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Webber, Elaine, and Jean Benedict. "Billing for Professional Lactation Services: A Collaborative Practice Approach." Clinical Lactation 6, no. 2 (May 2015): 60–65. http://dx.doi.org/10.1891/2158-0782.6.2.60.
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Studies indicate support following discharge is a key component to improved breastfeeding outcomes. Many women do not have access to professional lactation support because of financial constraints. Until direct insurance reimbursement for lactation consultant services is consistent and universal, creative solutions are needed. A collaborative practice model between lactation consultants and medical healthcare providers is one approach. A community hospital implemented an outpatient lactation clinic coordinated by lactation consultants working in conjunction with in-hospital pediatricians and nurse practitioners. Patients are seen jointly by both the lactation consultant and medical care provider, with services billed to commercial and state insurances through the medical practice. The outcome is increased access to care, improved breastfeeding outcomes with greater patient satisfaction, and increased revenues for the facility.
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Reinert, Bonita R., and Elizabeth A. Buck. "Issues in Liability Insurance and the Nursing Consultant." Clinical Nurse Specialist 3, no. 1 (1989): 42–45. http://dx.doi.org/10.1097/00002800-198900310-00014.
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Reinert, Bonita R., and Elizabeth A. Buck. "Issues in Liability Insurance and the Nursing Consultant." Clinical Nurse Specialist 3, no. 1 (1989): 42–45. http://dx.doi.org/10.1097/00002800-198921000-00014.
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Snyder-Drummond, Robin, Heather Bingham, and Jessica M. Lang. "Massachusetts Parents’ Experiences With Insurance Coverage for Lactation Consultant Services." Clinical Lactation 8, no. 1 (2017): 10–16. http://dx.doi.org/10.1891/2158-0782.8.1.10.
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The Women’s Preventive Services component of the Affordable Care Act (ACA) requires coverage of “lactation supplies and services” with no out-of-pocket cost to the patient. However, as IBCLCs providing in-home lactation consults, we found that during the first year of the ACA mandate, clients often described disappointment with coverage for home visits and for breastfeeding support in general. To have a more specific picture of women’s experiences, our association conducted an online survey of families in Massachusetts who sought insurance coverage for IBCLC care outside of the hospital since the ACA provisions came into effect. The goal was to identify the barriers that families who need these services commonly dealt with. Barriers reported by survey respondents included confusing and inconsistent information provided by insurance companies about coverage, lack of coverage for the time and place they sought IBCLC services, lack of coverage for IBCLCs at all, and restriction to a network that did not include IBCLC providers. These findings suggest that many women are not yet receiving the benefits of insurance coverage for lactation support and point to specific changes that insurance providers should make to provide adequate coverage as mandated under the ACA.
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Sung, Jaeyoung. "Corporate Insurance as a Necessary Form of Consultant—Investigator Contract." Geneva Papers on Risk and Insurance Theory 24, no. 2 (November 1999): 193–207. http://dx.doi.org/10.1023/a:1008793611953.
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Poerbonegoro, Galuh Adhitia, Margono Setiawan, and Sudjatno . "The Phenomena of Organizational Structure Change as Change Factor of Financial Consultant’s Motivation." KINERJA 21, no. 2 (September 16, 2017): 159. http://dx.doi.org/10.24002/kinerja.v21i2.1277.
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Life insurance has developed into an attractive industry and has an important role in supporting businesses, families and communities. It grew into a business commodity that attracted many people. Competition in the life insurance industry is increasingly complex and competitive due to the number of life insurance companies made a lot of customers have many choices that requires every company to be more responsive to acquire customers, to support the organizational change, motivation and performance of employees. According to the first interview with top management, obtained information that there is a distance between superiors and subordinate in Allianz Life Indonesia’s new system, where Business Partner (leader) only served to control Business Executive and give freedom to the actions carried out by subordinates so that the relationship between them is less synergy. The purpose of research is to describe implementation strategies and the impact of OSC to Financial Consultant’s motivation. This study uses a qualitative research method. Research results obtained implementation strategy of OSC, which influenced by factors such as the driver of an effective and efficient work system, increasing of industry competition, and maintaining customer trust. There are two impact to Financial Consultant’s motivation include intrinsic motivation and extrinsic motivation.Keywords: Insurance, Organizational Structure Change, Motivation, Financial Consultant
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Zichello, Christine, and Jim Sheridan. "Occupational Health Nurses and Workers' Compensation Insurance Programs." AAOHN Journal 56, no. 11 (November 2008): 455–58. http://dx.doi.org/10.3928/08910162-20081101-07.
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Today's occupational health nurse is likely a clinician, educator, case manager, consultant, and risk manager. Occupational health nurses improve working conditions, prevent injuries, reduce insurance-related costs, and rehabilitate workers. They not only develop health service programs taking into account both the welfare of workers and the organization's bottom line, they also make budgetary and staffing recommendations for the programs' implementation. Occupational health nurses must understand their organizations' workers' compensation insurance programs, how these programs work, and how nurses can maximize the companies' worker advantages and bottom line.
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Zichello, Christine, and Jim Sheridan. "Occupational Health Nurses and Workers' Compensation Insurance Programs." AAOHN Journal 56, no. 11 (November 2008): 455–58. http://dx.doi.org/10.1177/216507990805601103.
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Today's occupational health nurse is likely a clinician, educator, case manager, consultant, and risk manager. Occupational health nurses improve working conditions, prevent injuries, reduce insurance-related costs, and rehabilitate workers. They not only develop health service programs taking into account both the welfare of workers and the organization's bottom line, they also make budgetary and staffing recommendations for the programs' implementation. Occupational health nurses must understand their organizations' workers' compensation insurance programs, how these programs work, and how nurses can maximize the companies' worker advantages and bottom line.
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Shafer, Brian Michael, Thomasine Gorry, Paul Tapino, and Subha Airan-Javia. "Carelign: A Novel Handoff System for Medical and Surgical Consultants." Journal of Academic Ophthalmology 12, no. 01 (January 2020): e63-e66. http://dx.doi.org/10.1055/s-0040-1712173.
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Abstract Background Patient handoffs are ubiquitous in hospital settings. Historically, formal handoffs of patient information have been conducted in the inpatient setting mainly by primary teams, as opposed to medical and surgical consultants. Carelign is a software developed by the University of Pennsylvania Health System to function as an interdisciplinary, patient-centered handoff. While mainly utilized by primary teams for work management and transitions, it has been enhanced to include specialty consultant handoff functionality. Objective The aim of this study is to determine whether using Carelign for consultant handoffs improves clinical handoffs in comparison to the prior handoff system (a custom-built handoff report within the electronic health record) used by the Department of Ophthalmology at Penn Presbyterian Medical Center. Methods A 7-item questionnaire assessing the effectiveness, efficiency, accessibility, reliability, communication, and security of the handoff using a 1 to 5 scale was distributed to residents prior to and 6 months subsequent to the implementation of Carelign. Results Users reported a statistically significant increase in Health Insurance Portability and Accountability Act (HIPPA)-compliance (44 vs. 100%, p < 0.0001) and ability to communicate with primary teams (38 vs. 70%, p = 0.019) after implementation of Carelign. There was a trend toward significance with ease of accessing information after switching to Carelign (67 vs. 85%, p = 0.185). There was no statistically significant difference in effectiveness, efficiency, accessibility from home, or reliability of information on handoff after converting to the new system. Conclusion Carelign is perceived to be an effective tool that can be used by consulting providers to ensure HIPPA-compliance and the ability to communicate with primary teams without sacrificing effectiveness, efficiency, accessibility, or reliability.
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Zhukevych, Svitlana, and Nataliia Karpyshyn. "FINANCIAL CONSULTING FOR CITIZENS: THEORETICAL AND ORGANIZATIONAL ASPECTS OF ACTIVITY." Economic Analysis, no. 27(2) (2017): 91–97. http://dx.doi.org/10.35774/econa2017.02.091.
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The development of a financial consulting for citizens and promotion of financial consulting services have a positive effect on the efficiency of managing personal finances and the welfare of citizens. The theoretical and organizational aspects of financial advising of the population and the problems of its functioning in Ukraine are analyzed in the article. The financial consulting for citizens is the process of interaction between a consultant and a client (an individual). It is based on a particular methods or technology and involves providing fee or free information in the form of advice, conclusions and recommendations on optimization, rational using and profitable investment of personal funds. An independent financial adviser is an important subject in the financial consulting market that provides professional advices on getting a loan, choosing an insurance or retirement plan, placing a deposit, creating a family budget or personal financial plan. The personal financial plan is the main tool for the independent financial adviser. This is an action plan that is developed for a particular person or family to achieve the desired financial goals and includes selection of credit, investment, insurance, pension and other financial products. The preparation of the financial plan involves the development of an investment strategy and the creation of a financial protection plan. The services of independent financial advisers are not popular within the Ukrainian citizens because of their low purchasing power, high level of distrust regarding the professionalism of independent financial advisers and the quality of consulting services and the lack of awareness of the benefits of financial counseling.
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Becker-Dreps, Sylvia, Anne M. Butler, Leah J. McGrath, Kim A. Boggess, David J. Weber, Dongmei Li, Michael G. Hudgens, and J. Bradley Layton. "Effectiveness of Prenatal Tdap Immunization in the Prevention of Infant Pertussis in the United States." Open Forum Infectious Diseases 4, suppl_1 (2017): S68. http://dx.doi.org/10.1093/ofid/ofx162.163.
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Abstract Background The Centers for Disease Control and Prevention recommends that all pregnant women in the United States receive tetanus-diphtheria-acellular pertussis (Tdap) immunization to prevent infant pertussis. While the vaccine may be administered at any time during pregnancy, the recommendations define administration at 27 to 36 weeks of gestation as optimal timing to prevent infant pertussis. These recommendations were primarily based on immunogenicity studies. The objective of this study was to examine the clinical effectiveness of prenatal Tdap, and to understand whether effectiveness varies by gestational age at immunization. Methods We performed a nationwide cohort study of pregnant women with deliveries in 2010–2014 and their infants. Commercial insurance claims data were used to identify receipt of Tdap immunization in the pregnant women, and hospitalizations and outpatient visits for pertussis in their infants until 18 months of age. To address the difficulties in diagnosing pertussis, we also employed a “probable pertussis” definition, as an inpatient or outpatient diagnosis of pertussis, plus antibiotic treatment with a macrolide or trimethoprim/sulfamethoxazole within 7 days of diagnosis. Pertussis occurrence was compared between infants of mothers who received prenatal Tdap (overall, and stratified by gestational age at administration) and infants of unvaccinated mothers. Results There were 675,167 mother–infant pairs included in the cohort. Among infants whose mothers received Tdap at any time during pregnancy, the rate of pertussis hospitalization was 50% lower (adjusted hazards ratio (HR) = 0.50, 95% CI: 0.23, 1.09), and the rate of probable pertussis was 42% lower (HR = 0.58, 95% CI: 0.38, 0.89) than infants of unimmunized mothers. Pertussis rates were also lower for infants whose mothers received prenatal Tdap during the third trimester. Infants whose mothers received Tdap before the third trimester also tended to have lower rates of pertussis, but these estimates were imprecise. Conclusion Infants of mothers who received prenatal Tdap experienced half the rate of pertussis as compared with infants of unimmunized mothers. Our results do not provide evidence to support changing the currently recommended timing of Tdap administration in pregnancy. Disclosures S. Becker-Dreps, Pfizer: Consultant and Grant Investigator, Consulting fee and Research grant; A. M. Butler, Astra Zeneca: Consultant, Support to institution; Amgen: Grant Investigator, Investigator initiated grant to institution; 
D. J. Weber, Merck: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium; Pfizer: Consultant, Consulting fee; J. B. Layton, Merck: Member of Center for Pharmacoepidemiology, Support to institution; GlaxoSmithKline: Member of Center for Pharmacoepidemiology, Support to institution; UCB Biosciences: Member of Center for Pharmacoepidemiology, Support to institution
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Gibson, Sheree, Richard Kelly, SD Miller, and Tom Albin. "Human Factors Consulting: The Ins & Outs, Ups & Downs, Pros & Cons." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 62, no. 1 (September 2018): 878. http://dx.doi.org/10.1177/1541931218621200.
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The objective of this panel is to provide attendees with the opportunity to learn about what they always wanted to know about the wide world of human factors consulting, but were afraid to ask (or didn’t know to ask). This session should be of interest to meeting attendees at any stage of their career, including students and those who might be considering a career change or branching out. These panelists, together, have experience over a wide range of consulting domains, as well as being individuals who are at different stages in their consulting careers. As such, the panel session will provide attendees with multiple perspectives on select topics and on responses to attendees’ questions. Sheree Gibson, PE, CPE is President of Ergonomic Applications, a small industrial ergonomics consulting firm in South Carolina. She has been a consultant for most of her professional life, working for a forensic consulting firm as well as an in-house ergonomics consultant for Michelin Tire before setting out on her own. She has a B.S. in Mechanical Engineering and a M.S.E. in Applied Ergonomics, both from West Virginia University. She is active in the American Industrial Hygiene Association, the American Society of Safety Engineers and HFES. Sheree is also Vice-President of the Foundation for Professional Ergonomics. Richard Kelly, PhD earned his doctorate in Engineering Psychology from New Mexico State University and went on to work as an engineering psychologist for the Army at White Sands and then for the Navy at SPAWAR in San Diego. After about 10 years supporting large and small RDT&E programs and leading teams of scientists and engineers, he left the government to start Pacific Science & Engineering (PSE). Over the past 34 years, PSE has grown steadily from 2 to 50 employees and has been a prime contractor, subcontractor, and consultant on hundreds of projects in many different domains, including military, intelligence, industrial process, commercial, medical, education, autonomous vehicles, and more. PSE remains an independent, employee-owned company entirely focused on human performance in complex systems. The technical staff have received numerous recognitions from clients and professional groups for their outstanding work that makes a real difference for our users. Dee Miller, PhD works at Dell, Inc. in the Business Transformation Office as the Senior Principal UX & Service Design Engineer building relationships and appropriately influencing relevant internal teams and direct business contacts in the adoption of a human-centered approach to designing internal systems and processes and delivering services related to Order Experience Life Cycle. She recently started an independent consultancy called Dawn Specialty Consulting. One of the first projects of the new consultancy is consulting with a local non-profit and a police department on applying design thinking to community policing initiatives. Dee has prior experience consulting with state and federal government agencies on matters pertaining to transportation and healthcare. Tom Albin, PE, CPE, PhD is a licensed professional engineer and a certified professional ergonomist. He holds a PhD from the Technical University of Delft in the Netherlands. Currently the principal of High Plains Ergonomics Service, Tom has been engaged in ergonomics consulting since 2001. He has extensive experience as a researcher, a corporate ergonomist and as a product developer. He is active in the US and International Standards community, chairing the ANSI/HFES 100 computer workstation standard and serving as an accredited US expert on several ISO committees. He was Executive Director of the Office Ergonomics Research Committee from 2007 until retiring in 2018. Tom’s consulting work has been principally concerned with physical ergonomics issues in office and industrial settings. Current projects deal with evaluation of injury risk during push and pull tasks and with applied anthropometry. Topics Panelists will each be given time to introduce themselves at the beginning of the session. Each will speak for 7-10 minutes about their career path, ‘what I like best about consulting’, and ‘3-5 things I wish I had known before I started consulting’. The panel will also address the following topics: ethics, running a business (business plans, financing, insurance, legalities, managing employees, marketing, building relationships with clients, and writing contracts), and work/life balance. These topics will be introduced, in the form of questions from the moderator if/when questions from the audience are exhausted.
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Krilov, Leonard R., Jaime Fergie, Mitchell Goldstein, Christopher Rizzo, Lance Brannman, Jeffrey McPheeters, Stephanie Korrer, Tanya Burton, and Lucie Sharpsten. "743. Severity and Costs of Respiratory Syncytial Virus and Bronchiolitis Hospitalization in Commercially Insured Preterm and Term Infants Before and After the 2014 American Academy of Pediatrics Guidance Change on Immunoprophylaxis." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S267. http://dx.doi.org/10.1093/ofid/ofy210.750.
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Abstract Background In 2014, the American Academy of Pediatrics (AAP) stopped recommending respiratory syncytial virus (RSV) immunoprophylaxis in infants 29–34 weeks gestational age (wGA) without chronic lung disease (CLD) or congenital heart disease (CHD). This study examined the impact of this guidance change on the severity and costs of first year of life RSV hospitalizations (RSVH) and all-cause bronchiolitis hospitalizations (BH) among preterm (PT) vs. term infants in the 2014–2016 seasonal years relative to the 2011–2014 seasonal years. Methods Infants aged <1 year between July 1, 2011 and June 31, 2016 were identified from commercial insurance claims in the Optum Research Database. Diagnosis codes identified births of term and 29–34 wGA infants without CLD, CHD, or other health problems, RSVH, and BH. Length of stay (LOS), admission to the intensive care unit (ICU), and use of mechanical ventilation (MV) captured RSVH and BH severity. Costs were adjusted to 2015 USD. Results A total of 362,382 births (29–34 wGA and term without major health problems) were identified, of which 13,666 (3.8%) were PT. RSVH and BH were more severe among PT infants in 2014–2016 vs. 2011–2014, with a greater mean LOS (RSVH: 6.8 vs. 4.7 days, P = 0.008; BH: 7.2 vs. 4.6, P = 0.021), a higher proportion of infants admitted to the ICU (RSVH: 42.4% vs. 25.3%, P = 0.014; BH: 39.1% vs. 23.7%, P = 0.009), and increased use of MV (RSVH: 14.1% vs. 6.1%, P = 0.067; BH: 14.8% vs. 5.3%, P = 0.013). Among term infants, LOS and ICU admissions were similar between 2014–2016 and 2011–2014 (P > 0.05), but there was an increased use of MV in the 2014–2016 season (RSVH: 6.9% vs. 4.2%, P = 0.009; BH: 6.3% vs. 3.7%, P = 0.003). Mean costs per hospitalization were greater for PT infants in 2014–2016 compared with 2011–2014 (RSVH: $29,382 vs. $16,572, P = 0.059; BH: $26,101 vs. $15,896, P = 0.047), whereas mean term hospitalization costs were similar (RSVH: $15,011 vs. $15,472, P = 0.705; BH: $14,555 vs. $14,603, P = 0.957). Conclusion RSVH and BH severity and per-hospitalization costs (higher among PT infants relative to term infants) increased following the 2014 AAP immunoprophylaxis guidance change. The increases are likely explained by more frequent RSV hospitalizations among higher-risk 29–34 wGA infants in 2014–2016. Funded by AstraZeneca Disclosures L. R. Krilov, AstraZeneca/MedImmune: Consultant, Research grant and Research support. J. Fergie, AstraZeneca/MedImmune: Consultant and Speaker’s Bureau, Research grant and Research support. M. Goldstein, AstraZeneca/MedImmune: Consultant, Research grant and Research support. C. Rizzo, AstraZeneca: Employee, Salary and Stocks. L. Brannman, AstraZeneca: Employee, Salary and Stocks. J. McPheeters, Optum: Employee, Salary. AstraZeneca: Research Contractor, Consulting fee. S. Korrer, Optum: Employee, Salary. AstraZeneca: Research Contractor, Consulting fee. T. Burton, Optum: Consultant and Employee, Salary. AstraZeneca: Research Contractor, Consulting fee. L. Sharpsten, Optum: Employee, Salary. AstraZeneca: Research Contractor, Consulting fee.
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Petigara, Tanaz, Ya-Ting Chen, Zhiwen Liu, Michelle Goveia, David Johnson, and Gary S. Marshall. "1393. Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US)." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S706. http://dx.doi.org/10.1093/ofid/ofaa439.1575.
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Abstract Background The US vaccination schedule includes DTaP, IPV, Hib and HepB doses in the first 6 months of life. A previous analysis found variability in the timing of HepB doses in infants receiving DTaP-IPV/Hib. We explored factors associated with co-administration of DTaP-IPV/Hib and HepB on the same day. Methods This was a retrospective study using the MarketScan® commercial claims and encounters database. Infants born from 1 July 2010 - 30 June 2016, continuously enrolled in an insurance plan for ≥ 13 months and receiving ≥ 3 DTaP-IPV/Hib doses were included. Infants were assessed for HepB claims relative to the first and third DTaP-IPV/Hib doses. Because a HepB birth dose was assumed, the first HepB claim from 29 - 169 days following birth was counted as Dose 2, and the second claim from 170 days - 12 months as Dose 3. Associations between demographic, provider, and insurance characteristics, receipt of other pediatric vaccines, and co-administration of DTaP-IPV/Hib and HepB were analyzed using multivariate logistic regression. Results Among 165,553 infants who received a first DTaP-IPV/Hib dose, 60.7% received HepB Dose 2 on the same day. Among 162,217 infants who received a third DTaP-IPV/Hib dose, 45.1% received HepB Dose 3 on the same day. Infants in the Northeast were less likely (OR=0.38, 95%CI=0.36-0.39), while those in the West were more likely (OR=1.41, 95%CI=1.36-1.46) than infants in the South to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day. Infants vaccinated by pediatricians (OR=0.54, 95%CI=0.53-0.55) were less likely to receive the first dose of DTaP-IPV/Hib and HepB Dose 2 on the same day compared to infants vaccinated by family physicians. Infants who received PCV on the same day as the first dose of DTaP-IPV/Hib were more likely to receive HepB Dose 2 (OR=6.96, 95%CI=6.30-7.70) that day. These factors were also associated with co-administration of the third dose of DTaP-IPV/Hib and HepB Dose 3. Conclusion Differences in co-administration of DTaP-IPV/Hib and HepB were associated with region of residence, provider type and co-administration of PCV. The reasons underlying these differences merit exploration. A hexavalent vaccine containing DTaP, IPV, Hib, and HepB could improve timeliness of HepB vaccination, while reducing the number of injections during infancy. Disclosures Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder) Ya-Ting Chen, PhD, Merck & Co., Inc. (Employee, Shareholder) Zhiwen Liu, PhD, Merck & Co., Inc., (Employee) Michelle Goveia, MD, Merck & Co., Inc (Employee, Shareholder) David Johnson, MD, MPH, Sanofi Pasteur (Employee, Shareholder) Gary S. Marshall, MD, GlaxoSmithKline (Consultant, Scientific Research Study Investigator)Merck (Consultant, Scientific Research Study Investigator)Pfizer (Consultant, Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Grant/Research Support, Scientific Research Study Investigator, Honorarium for conference lecture)Seqirus (Consultant, Scientific Research Study Investigator)
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Handy, Lori, Jeffrey S. Gerber, Matthew Bryan, Theoklis Zaoutis, and Kristen Feemster. "Comparative Effectiveness of β-lactams Vs Azithromycin for Treatment of Outpatient Pediatric Community-acquired Pneumonia." Open Forum Infectious Diseases 4, suppl_1 (2017): S3—S4. http://dx.doi.org/10.1093/ofid/ofx162.007.
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Abstract Background Guidelines recommend amoxicillin as first-line therapy for mild, community-acquired pneumonia (CAP) in healthy, immunized children because of its effectiveness against S. pneumoniae. However, macrolides, which have inferior anti-pneumococcal activity, are the most commonly prescribed class of antibiotics for outpatient CAP. We aimed to determine the comparative effectiveness of β-lactam vs. macrolide antibiotics for the treatment of CAP. Methods We conducted a retrospective cohort study in 31 pediatric primary care practices. Patients 3 months to 18 years of age with CAP diagnosed between January 1, 2009 and December 31, 2013 were identified by ICD-9-CM codes. Clinical data were abstracted electronically. Treatment failure was defined as change in antibiotic by the pediatrician, emergency department (ED) visit, or hospitalization for pneumonia in the 2 weeks following diagnosis. Multivariable logistic regression models including children prescribed monotherapy of amoxicillin, broad-spectrum β-lactam antibiotics, or macrolides were built to determine the association of each class with treatment failure, adjusting for clinical and demographic characteristics. Results Of 10,470 children who received antibiotics for pneumonia, 4252 (40.6%) received amoxicillin, 4459 (42.6%) received macrolides, and 1759 (16.8%) received broad-spectrum β-lactams. The groups differed by age category, proportion of black patients, insurance type, documented fever, ordering of a chest X-ray, and prior antibiotic exposure. Treatment failure occurred in 633 children (6.1%); 418 required a change in antibiotic by the pediatrician, 169 required an ED visit, and 47 required hospitalization. In the adjusted model, macrolide prescribing was associated with a decreased odds of treatment failure in children <5 years old (aOR = 0.52, 95% CI 0.34, 0.78) and in children ≥5 years old (aOR = 0.32, 95% CI 0.25, 0.41). In practices with the lowest macrolide use, this relationship persisted (OR 0.46; 95% CI 0.23, 0.92). Conclusion While rates of treatment failure in children diagnosed with CAP in the outpatient setting were low, macrolides were associated with a lower failure rate than treatment with β-lactams. This may be due to residual confounding by indication or changing epidemiology of outpatient pneumonia. Disclosures T. Zaoutis, Astellas: Consultant, Consulting fee; Merck: Grant Investigator, Research grant; nabriva: Consultant, Consulting fee.
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Rowe, Kyle, Whitney Rowe, Josh Umbehr, Frank Dong, and Elizabeth Ablah. "Direct Primary Care in 2015." Kansas Journal of Medicine 10, no. 1 (January 14, 2019): 3–6. http://dx.doi.org/10.17161/kjm.v10i1.8640.
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Introduction. Direct primary care (DPC), a fee for membershiptype of practice, is an evolving innovative primary caredelivery model. Little is known about current membershipfees, insurance billing status, physician training, and patientpanel size in DPC practices. This study aimed to obtain currentdata for these variables, as well as additional demographicand financial indicators, and relate the findings to the HealthyPeople 2020 goals. It was predicted that DPC practices would(1) submit fewer claims to insurance, (2) have decreased membershipfees, (3) be primarily family medicine trained, and(4) have increased the projected patient panel size since 2005.
Methods. An electronic survey was sent to DPC practices(n = 65) requesting location, membership fees, projectedpatient panel size, insurance billing status, training,and other demographic and financial indicators. Datawere aggregated, reported anonymously, and compared totwo prior characterizations of DPC practices done in 2005.
Results. Thirty-eight of 65 (59%) practices responded to the2015 survey. The majority of respondents (84%) reported usingan EMR, offering physician email access (82%), 24-hour access(76%), same day appointments (92%), and wholesale labs (74%).Few respondents offered inpatient care (16%), obstetrics (3%),or financial/insurance consultant services. Eighty-eight percent(88%) of practices reported annual individual adult membershiprates between $500 and $1,499, decreased from 2005 where81% reported greater than a $1,500 annual fee. The proportion ofpractices who submit bills to insurance decreased from 75% in2005 to 11% in 2015. Fifty-six percent (56%) of practices reportedprojected patient panel size to be greater than 600, increasedfrom 40% in 2005. Family medicine physicians represented 87%of respondents, markedly different from 2005 when 62 - 77% ofDPC respondents were general internal medicine physicians.
Conclusions. Most DPC practices no longer submit to insuranceand are family medicine trained. Comparedwith the previous sampling, DPC practices report decreasedmembership fees and increased projected panelsize. These trends may signify the DPC movement’sgrowth in application and scope. KS J Med 2017;10(1):3-6.
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Curtis, J., K. Winthrop, B. Chan, S. Siegel, J. Stark, R. Suruki, R. Bohn, et al. "FRI0314 ANNUAL DIAGNOSTIC PREVALENCE OF ANKYLOSING SPONDYLITIS (AS) IN THE UNITED STATES USING MEDICARE AND MARKETSCAN DATA." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 747.1–748. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4246.
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Background:Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that affects the axial skeleton and sacroiliac joints, and can be classified as ankylosing spondylitis (AS) or non-radiographic (nr)-axSpA.1A 2016 analysis estimated the US diagnostic prevalence of axSpA to be 0.2% and AS to be 0.1%.2Previous studies use disparate populations and diagnostic definitions;3,4it is therefore unclear how AS prevalence has changed over time.Objectives:To investigate the annual diagnostic prevalence of AS in US healthcare insurance claims databases.Methods:A retrospective, observational cohort study was conducted using 2006–2014 data from US Medicare Fee-for-Service Claims (5% random sample of all enrolled patients [pts]) and Truven MarketScan®. Eligible pts were ≥20 years (yrs) and had ≥6 months of continuous medical and pharmacy enrolment prior to diagnosis. Diagnoses used relevant International Classification of Disease, 9thversion (ICD-9) diagnosis codes: ICD-9 720.x [x=any number] for “AS and other inflammatory spondylopathies [SpA]” or 720.0 for “AS”. Two diagnosis definitions were used: Definition 1, ≥1 relevant ICD-9 code from hospital discharge or ≥2 from rheumatologist visit; Definition 2, ≥1 relevant ICD-9 code from hospital discharge or rheumatologist visit. Annual diagnostic prevalence of SpA/AS was calculated as “number of enrolled pts who met the definition of SpA/AS within each calendar yr and had full insurance coverage (medical and pharmacy)”, divided by “total number of pts with full insurance coverage in the same yr”. A primary analysis of SpA prevalence rates used Definitions 1 and 2, followed by a sensitivity analysis for AS prevalence rates using only Definition 2. All prevalence rates are shown per 10,000 pts enrolled.Results:The annual diagnostic prevalence of SpA appeared to increase from 2006–2014 (Table). Similarly, the sensitivity analysis showed the annual diagnostic prevalence of AS appeared to increase during the period from 2006 (Medicare: 2.87/10,000 pts [n=501,031]; MarketScan: 1.37/10,000 pts [n=17,562,637]) to 2014 (Medicare: 4.77/10,000 pts [n=1,046,107]; MarketScan: 2.14/10,000 pts [n=34,553,135];Figure).Conclusion:The apparent increase in diagnostic prevalence of SpA and AS during the period from 2006–2014 may be a consequence of increased awareness and availability of effective treatments. Furthermore, the 2009 Assessment of SpondyloArthritis international Society development of the axSpA classification criteria to include pts with both established AS and nr-axSpA may have accelerated this increase.5References:[1]Strand V. Mayo Clin Proc 2017;92:555–64;[2]Curtis J. Perm J 2016;20:15–151;[3]Reveille J. Arthritis Care Res (Hoboken) 2012;64:905–10;[4]Danve A. Clin Rheumatol 2019;38:625–34;[5]Rudwaleit M. Ann Rheum Dis 2009;68:777–83.Table.Prevalence of SpA by calendar year and data sourceMedicare (5% random sample)MarketScanCalendar yrTotal number of eligible ptsPrevalence/10,000 ptsTotal number of eligible ptsPrevalence/10,000 ptsDefinition 1Definition 2Definition 1Definition 22006501,0314.397.6217,562,6371.332.172007816,9705.258.7219,518,0661.472.372008825,4454.898.7828,603,5251.582.532009830,9675.229.2131,757,0691.903.092010844,5285.499.9031,126,1721.963.172011879,9966.3010.7138,295,1211.943.112012921,9946.1710.8840,320,4371.913.0420131,032,8276.7410.8233,826,0412.003.1920141,046,1076.5210.8534,553,1352.213.51Medicare data included a 5% random sample of all enrolled pts age ≥20 yrs. pts: patients; SpA: ankylosing spondylitis and other inflammatory spondylopathies; yr: year.Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma, Kevin Winthrop Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer Inc, Roche, UCB, Benjamin Chan: None declared, Sarah Siegel: None declared, Jeffrey Stark Employee of: UCB Pharma, Robert Suruki Employee of: UCB Pharma, Rhonda Bohn Consultant of: UCB Pharma, Fenglong Xie: None declared, Huifeng Yun Grant/research support from: Bristol-Myers Squibb and Pfizer, Lang Chen: None declared, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB
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Rawlings, Keith M., Joseph J. Eron, Julie Priest, Janna Radtchenko, Joseph Mrus, Moti Rampogal, Alan Oglesby, Faith Fletcher, and Richard A. Elion. "1704. Regional and Racial Disparities in Response to Antiretroviral Therapy (ART) among People Living with Human Immunodeficiency Virus (PLWH)." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S835. http://dx.doi.org/10.1093/ofid/ofaa439.1882.
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Abstract Background This study evaluated differences in viral suppression by race and region among PLWH in care at 10 community practices. Methods PLWH (≥18 yrs) starting a new ART between Jan’15-Sept’19 with viral load at regimen prescription (Rx) and ≥6 months (mo) of prior history were selected from Trio Health HIV EMR database. Logistic regression [LR] estimated the association of covariates with outcome “viremic” (viral load >50 cells/ml) among those with viral load recorded 12-15 mo after baseline (BSL). Sensitivity analyses were conducted using viral loads at 9-15 mo, in patients (pts) on their BSL regimens for ≥12 mo, and pts with dispensing data. Covariates: BSL suppression, gender, race, age, payer, region (South vs non-South), BSL single vs multi-tablet regimen (STR vs MTR), and switch status from BSL regimen. Multicollinearity was not present. Results Of 20271 PLWH, 10373 (51%) were treated in South (41% not suppressed at BSL including 30% treatment-naïve [TN]) and 9898 (49%) in non-South (32% not suppressed including 26% TN). The following groups had higher suppression rates at 12-15 mo: males (83%) vs females (80%) p=0.003; white (85%) vs black (78%) and other known race (78%) p< 0.001; insured by commercial or Medicare insurance (both 85%) vs Medicaid (76%) or uninsured (71%) p< 0.001; treated in non-South (88%) vs South (77%) p< 0.001; age ≥50 (87%) vs < 50 (80%) p< 0.001, those who did not switch from BSL regimen (84%) vs switchers (82%) p< 0.001; on STR (84%) vs MTR (81%) p< 0.001. In LR, pts less likely to be suppressed at 12-15 mo were: < 50 adjusted odds ratio (aOR)=0.76 (0.67-0.88), unspecified gender vs female aOR=0.51 (0.28-0.92), black vs white aOR=0.65 (0.56-0.74), other race (Asian, etc.) vs white aOR=0.73 (0.59-0.91), insured by Medicaid vs commercially aOR=0.64 (0.50-0.82), uninsured vs commercially insured aOR=0.63 (0.53-0.75), treated in South aOR=0.43 (0.38-0.50), switched from BSL regimen aOR=0.75 (0.66-.086), on MTR vs STR aOR=0.81 (0.72-0.92), viremic at BSL aOR=0.41 (0.36-0.47). Sensitivity analyses results were similar. Conclusion Our findings highlighted higher rates of viremia among younger, black or other non-white race, pts treated in the South, on Medicaid or uninsured, on MTR, even after accounting for other characteristics. Disclosures Keith M. Rawlings, MD, ViiV Healthcare (Employee) Joseph J. Eron, MD, Gilead Sciences (Consultant, Research Grant or Support)Janssen (Consultant, Research Grant or Support)Merck (Consultant)ViiV Healthcare (Consultant, Research Grant or Support) Julie Priest, MSPH, GlaxoSmithKline (Employee, Shareholder) Janna Radtchenko, MBA, Trio Health (Employee) Joseph Mrus, MD, MSc, ViiV Healthcare (Employee) Moti Rampogal, MD, Gilead Sciences (Consultant, Research Grant or Support, Speaker’s Bureau)Janssen (Consultant, Research Grant or Support, Speaker’s Bureau)Merck (Consultant, Research Grant or Support)ViiV Healthcare (Consultant, Research Grant or Support, Speaker’s Bureau) Alan Oglesby, MPH, ViiV Healthcare (Employee) Richard A. Elion, MD, Gilead Sciences (Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)Jannssen (Speaker’s Bureau)Proteus (Research Grant or Support)Trio Health (Employee)ViiV Healthcare (Advisor or Review Panel member, Research Grant or Support)
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Alten, R., C. Behar, C. Boileau, P. Merckaert, E. Afari, V. Vannier-Moreau, S. Connolly, et al. "AB0205 A NOVEL METHOD FOR PREDICTING 1-YEAR RETENTION OF ABATACEPT USING MACHINE LEARNING TECHNIQUES: DIRECTIONALITY AND IMPORTANCE OF PREDICTORS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1127–28. http://dx.doi.org/10.1136/annrheumdis-2021-eular.868.
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Background:In the ACTION (NCT02109666) study, multivariable Cox proportional hazards regression models showed that the predictors of 1-year retention to abatacept treatment were: patient global pain assessment, country, reason for stopping last biologic, number of prior biologic treatments, abatacept monotherapy, RF/anti-cyclic citrullinated peptide (CCP) status, previous neoplasms, psychiatric disorders and cardiac disorders.1 Machine learning techniques, using the gradient-boosting model, subsequently identified additional predictors of abatacept retention in patients with moderate-to-severe RA enrolled in ACTION; however, the analysis did not show the directionality of the predictors.2Objectives:To improve the clinical interpretability of the machine learning model in terms of directionality and the importance of each variable in predicting retention.Methods:Previous analyses using the gradient-boosting model to identify predictors of abatacept retention at 1 year in the ACTION study have been described.2 This analysis used SHapley Additive exPlanations (SHAP), a mathematical framework, to show how a particular predictor value influences prediction in the context of all other predictors. Higher SHAP values indicate a higher likelihood of retention. The contribution of every variable in the model’s prediction (with the exception of country variables) was computed for each data point to capture individual variable impact. This enabled interpretation for level of importance and directionality at a patient level.Results:Using data from 2350 patients enrolled in ACTION (May 2008 to December 2013), the mean retention rate at 1 year was 59.3% (n=1393). Overall variable importance is shown in Figure 1. After removal of country variables, the top five baseline predictors of retention were: no previous corticosteroid use, ACR functional class II, ≥2 prior biologic treatments prior to abatacept initiation, abatacept monotherapy and HAQ-DI. In terms of directionality, no previous corticosteroid use, ≥2 prior biologic treatments prior to abatacept initiation, abatacept monotherapy and a higher HAQ-DI score at baseline were associated with a lower likelihood of retention; ACR functional class II was associated with a higher likelihood of retention.Conclusion:The gradient-boosting model previously identified predictors of abatacept retention from ACTION;2 the addition of SHAP in this analysis has provided information on the importance and directionality of those predictors. The most important predictor of abatacept retention was no previous corticosteroid use, which was associated with lower retention. The models and predictors identified could be further refined by using additional datasets from clinical trials. Machine learning offers an innovative and complementary approach to biostatistics and could be used to identify treatment response predictors at an individual patient level, leading to a more personalised treatment approach.References:[1]Alten R, et al. RMD Open 2017;3:e000538.[2]Alten R, et al. Presented at the virtual ACR Convergence 2020; 5–9 November 2020. Poster number 1745.Acknowledgements:This study was supported by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Claire Line, PhD, at Caudex and was funded by Bristol Myers Squibb.Disclosure of Interests:Rieke Alten Speakers bureau: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Consultant of: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Grant/research support from: AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Pfizer, Claire Behar Shareholder of: I have not invested directly in pharmaceutical companies producing drugs/devices for use in rheumatology however I may have shares via the funds linked to my life insurance., Consultant of: Bristol Myers Squibb, Christine Boileau Consultant of: AstraZeneca, Bristol Myers Squibb, Nanobiotix, Pierre Merckaert Consultant of: Bristol Myers Squibb, Ebenezer Afari Consultant of: Bristol Myers Squibb, Virginie Vannier-Moreau Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Sean Connolly Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Aurelie Najm Speakers bureau: Bristol Myers Squibb, Consultant of: Bristol Myers Squibb, Pierre-Antoine Juge Consultant of: Bristol Myers Squibb, Angshu Rai Shareholder of: Amgen Inc, Consultant of: Amgen Inc, Employee of: Amgen Inc, Bristol Myers Squibb, Yedid Elbez Consultant of: Bristol Myers Squibb, Karissa Lozenski Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb
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FOX, MARK D., GLENN McGEE, and ARTHUR CAPLAN. "Paradigms for Clinical Ethics Consultation Practice." Cambridge Quarterly of Healthcare Ethics 7, no. 3 (July 1998): 308–14. http://dx.doi.org/10.1017/s0963180198703111.
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Clinical bioethics is big business. There are now hundreds of people who “do” bioethics in community and university hospitals, nursing homes, rehabilitation and home care settings, and some (though quite a few less) who play the role of clinical ethics consultant to transplant teams, managed care companies, and genetic testing firms. Still, there is as much speculation about what clinically active bioethicists actually do as there was ten years ago. Various commentators have pondered the need for training standards, credentials, “certification” exams, and malpractice insurance for ethicists engaged in clinical consultation. Much of the discussion seems to accept an implicit presumption that all clinical ethics consultation practices look pretty much alike. But is this accurate? What do clinical ethicists do, how and where do they do it, and what kind of clinical ethics is useful in the hospital and in other settings?
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Ferguson, Andrew, and Gabriel Pündrich. "Does Industry Specialist Assurance of Non-Financial Information Matter to Investors?" AUDITING: A Journal of Practice & Theory 34, no. 2 (September 1, 2014): 121–46. http://dx.doi.org/10.2308/ajpt-50930.
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SUMMARY Previous studies in the financial economics literature highlight the value of non-financial information in Internet and telephony stocks (Amir and Lev 1996; Trueman, Wong, and Zhang 2001). Other studies consider the financial and share price performance implications of assurance of non-financial information such as ISO 9000 certification (Corbett, Montes-Sancho, and Kirsch 2005), Total Quality Management awards (Hendricks and Singhal 1997), and non-financial information disclosure (Coram, Monroe, and Woodliff 2009). However, prior studies have occurred in settings where disclosure and assurance of non-financial information is voluntary. We provide evidence on the value of assurance of non-financial information where the assurance of public resource disclosures made under the JORC Code by Australian Mining Development Stage Entities are mandatory. The assurance role undertaken by Competent Persons reporting under the JORC Code bears many close similarities to the financial reporting assurance role undertaken by auditors. Further, the information environment of MDSEs is characterized by high information asymmetry and the reality that the utility of non-financial technical information supersedes financial statement information in firm valuation. We document very weak evidence of greater abnormal returns evident when reserve disclosures are provided by specialist mining consultants. In supplementary analysis, we test for implications of switching mineral consultant and find that clients experience significant positive abnormal returns when the successor is larger. Overall, our findings support the insurance hypothesis, in that mandatory specialist assurance matters little where litigation risk is low.
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Cherabie, Joseph, Lindsey Larson, Sasinuch Rutjanawech, Alexander Franklin, Michael J. Hendrix, Jane A. O’Halloran, Rachel M. Presti, William Powderly, and Andrej Spec. "923. Long-term Mortality after Histoplasma Infection in People Living with HIV." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S495—S496. http://dx.doi.org/10.1093/ofid/ofaa439.1110.
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Abstract Background Histoplasmosis is a common opportunistic infection afflicting people living with HIV (PLWH) globally. There are no data on long term survival of PLWH with histoplasmosis. Methods We conducted a single-center retrospective cohort study of PLWH diagnosed with histoplasmosis between 2002 and 2017. Data collected included demographics, clinical characteristics, treatment, and mortality. Patients were categorized into three groups based on length of survival after diagnosis: early mortality (death within 90 days), late mortality (death at or after 90 days), and survivors. Between group differences in demographic and clinical characteristics were assessed using Chi square for categorical variables and Mann-Whitney U non-parametric tests for continuous variables. Mortality was compared using Cox proportional hazards. Insurance type (i.e. private versus public option) served as a surrogate indicator of socioeconomic status (SES). Patients diagnosed with histoplasmosis in or after 2008 were considered a part of the modern ART era, regardless of treatment regimen. Results Our review found 54 PLWH infected with histoplasmosis from 2002-2017. Overall mortality was 37%, with 14.8% early mortality and 22.2% late mortality. Median survival time in the early mortality group was 13.5 days (IQR 2.5-41 days), and 338 days (IQR 180.5-803.3) in the late mortality group. Compared to the late mortality group, survivors were over 6 times more likely to have suppressed HIV viral load at last observation (HR 6.19, p=0.013). Median HIV viral load at last observation was lower among the survivors (2 log copies/ml, IQR 0, 4.5) compared to the late mortality group (4.1 log copies/ml, IQR 2.6,5.5) (p=0.010). Survivors were twice as likely to have private insurance, but this did not reach statistical significance (HR 2.19, p=0.14). There was no statistically significant difference in survival based on the availability of modern ART (p=0.85). The year of diagnosis made no difference with regards to survival (p=0.914). Baseline Characteristics of PLWH with Histoplasmosis HIV-related Characteristics of PLWH with Histoplasmosis Conclusion Histoplasmosis continues to be associated with high mortality among PLWH. Improved long-term survival is seen in patients with suppressed HIV viral loads. Disclosures Andrej Spec, MD, MSCI, Astellas (Grant/Research Support)Mayne (Consultant)Scynexis (Consultant)
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Sakai, R., E. Tanaka, and M. Harigai. "AB1190 DIRECT MEDICAL COSTS OF HOSPITALIZATION DURING THE MAINTENANCE THERAPY IN PATIENTS WITH ANTINEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS USING JAPANESE HEALTH INSURANCE DATABASE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1885.2–1886. http://dx.doi.org/10.1136/annrheumdis-2020-eular.806.
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Background:Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) requires a long-term maintenance therapy (MT), often accompanied by hospitalization due to relapse and/or comorbidities such as infection1. However, data about direct medical costs of hospitalization during MT in patients with AAV is limited to date despite of an increasing concern about the economic burden of patients with AAV2-3.Objectives:To describe frequency of hospitalization and its direct medical costs during MT after the remission-induction therapy (RT) in patients with AAV using Japanese health insurance database.Methods:This retrospective longitudinal population-based study was conducted using claims data in Japan provided by Medical Data Vision Co., Ltd. We defined individuals as AAV cases receiving RT if they met all of the following: 1) having at least one ICD10 code (M300, M301, M313, or M318); 2) having at least one prescription of oral corticosteroids with prednisolone-equivalent dosage ≥30 mg/day, methylprednisolone pulse therapy, immunosuppressive drugs (cyclophosphamide [IVCY], methotrexate, or mycophenolate mofetil), or rituximab (RTX) during hospitalization between April 2008 and April 2017; and 3) having at least 7 days of hospitalization. The observation started from the next day of discharge from the first hospitalization for RT and ended at 24 months later, the month of loss of follow-up, or April 2017. We described the frequency of hospitalization and calculated direct medical costs (per month) during the observation. We analyzed medical costs from a societal perspective. We classified reasons of hospitalization into 3 categories; intensification of treatments for AAV, AAV MT including IVCY or RTX treatments, and comorbidities (infection, cardiovascular disease [CVD], malignancy, and others) using ICD10 codes plus treatments or interventions during the hospitalization.Results:In this study, 1,703 patients with AAV were included. The median [IQR] age was 72 [63, 79] years and 55.7% were female. The total number of hospitalization was 1,897 in 863 patients (50.7%). Among the hospitalizations, 296 hospitalization in 235 patients were categorized as intensification of treatments for AAV, 627 hospitalization in 297 patients were AAV MT, and 974 hospitalization in 572 patients were categorized as comorbidities. In the last category, infections were most frequent (220), followed by malignancy (54) and CVD (15). The mean direct medical costs per month was 20,945 EUR (1 EUR=125 JPY) in patients with hospitalization and 599 EUR in those without. Patients with hospitalization due to intensification of treatments for AAV had the highest direct medical costs (3,000 EUR), followed by those with hospitalization due to comorbidities (2,001 EUR), and those with hospitalization due to AAV MT (1,649 EUR).Conclusion:More than half of the patients had hospitalization during MT, and hospitalization due to comorbidities were most frequent. The mean direct medical costs in patients with at least one hospitalization was approximately 3.5 times as high as that in those without hospitalization.References:[1]Presse Med. 2015; 44:e251-e257[2]J. Rheumatol. 2015; 42:2383-91[3]Clin Exp Rheumatol.2019:137-43Acknowledgments:This work was supported by AMED under Grant Number JP17ek0109121.Disclosure of Interests:Ryoko Sakai Grant/research support from: Tokyo Women’s Medical University (TWMU) has received unrestricted research grants forDivision of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases from Ayumi Pharmaceutical Co. Ltd., Bristol Meyers Squib, Chugai Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., and with which TWMU paid the salary of R.S., Eiichi Tanaka Consultant of: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., Speakers bureau: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., masayoshi harigai Grant/research support from: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., and Teijin Pharma Ltd. MH has received speaker’s fee from AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Oxford Immuotec, Pfizer Japan Inc., and Teijin Pharma Ltd. MH is a consultant for AbbVie, Boehringer-ingelheim, Kissei Pharmaceutical Co., Ltd. and Teijin Pharma.
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McManus, Kathleen A., Karishma R. Srikanth, Samuel D. Powers, Rebecca Dillingham, and Elizabeth T. Rogawski McQuade. "1030. Medicaid Expansion: How Does it Impact HIV Outcomes in One Non-urban Southeastern Ryan White HIV/AIDS Program Clinic?" Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S544—S546. http://dx.doi.org/10.1093/ofid/ofaa439.1216.
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Abstract Background People living with HIV (PLWH) with Medicaid historically have lower viral suppression (VS) rates than those with other insurance. VS rates with Medicaid expansion (ME) are unknown. We examined HIV outcomes (engagement in care, VS) by insurance status for a non-urban Southeastern Ryan White HIV/AIDS Program (RWHAP) Clinic cohort for year after ME. Methods Participants were PLWH ages 18-63 who attended > 1 HIV medical visit/year in 2018 and 2019. Log-binomial models were used to estimate the association of characteristics with Medicaid enrollment prevalence and one-year risks of engagement in care and VS in 2019. Results Among 577 patients, 241 (42%) were newly eligible for Medicaid due to ME and 79 (33%) enrolled (Figure 1a). For those without Medicare, Medicaid enrollment was higher for those with incomes < 100% FPL (adjusted prevalence ratio [aPR] 1.67; 95% confidence interval [CI] 1.00-1.86) compared to those with incomes > 101% FPL. Those enrolled in Medicaid due to ME had 87% engagement in care compared to 80-92% for other insurance plans (Figure 1b). Controlling for 2018 engagement, older age (adjusted risk ratio [aRR] for 10 years 1.03, 95% CI 1.00-1.05; Table 1) was associated with being engaged in 2019. Engagement was lower for those with employment-based insurance (aRR 0.91, 95% CI 0.83-0.99) and Medicare (aRR 0.87, 95% CI 0.78-0.96). Of those with viral loads in 2018 and 2019 (n=549), those who newly enrolled in Medicaid due to ME had 85% VS compared to 87-99% for other insurance plans (Figure 1c). In univariate analysis, age, income, and baseline viral load status were associated with viral suppression (Table 2), and those with Medicaid due to ME (aRR 0.90, 95% CI 0.81-1.00) were less likely to achieve VS compared with others. Figure 1 Table 1 Table 2 Conclusion The low uptake of ME was likely influenced by many PLWH already having Medicare. While the RWHAP supports high quality HIV care, Medicaid enrollment improves access to non-HIV care and should be supported by RWHAP. Given that engagement in care was high for PLWH who newly enrolled in Medicaid, the finding of lower VS is surprising. The discordance may be due to medication access gaps associated with changes in pharmacy logistics. Future studies with larger cohorts will need to examine how ME contributes to PLWH’s overall health and to ending the HIV epidemic. Disclosures Kathleen A. McManus, MD, MSCR, Gilead Sciences, Inc (Research Grant or Support, Shareholder) Rebecca Dillingham, MD, MPH, Gilead Sciences, Inc (Research Grant or Support)Warm Health Technologies, Inc (Consultant)
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Dixon, Steven, and Sean Woodcock. "When can I drive? Advising patients when to drive after general surgical procedures." Journal of Patient Safety and Risk Management 23, no. 6 (August 16, 2018): 239–42. http://dx.doi.org/10.1177/2516043518794323.
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Introduction Advising patients when they are medically fit to drive following general surgical procedures is crucial to minimise risk to patients, the general public as road user’s and pedestrians and also avoid negligence claims against medical practitioners. Historically, in the UK, this advice has come from a number of sources including surgeons, general practitioners, insurers and the Driver and Vehicle Licensing Agency (DVLA). The aim of this study was to review how current surgical teams distribute this advice and what this advice is based upon. Materials and methods An online survey was devised and distributed to all consultant general surgeons and trainees in the North East of England via email. Leading vehicle insurance companies and the DVLA were contacted to assess what advice they gave for specific procedures (ventral hernia, appendicectomy, cholecystectomy, fundoplication). Results A total of 135 surveys were distributed, 56 were returned, with a response rate of 41.5%. Twenty-two (39.3%) of respondents were consultants, 30 (53.6%) were speciality trainees (ST3-8) and 4 (7.1%) were core surgical trainees (CT1-2). Some (14.2%) gave driving advice to every patient, 39.3% gave advice to most patients; 42.9% gave advice pre-operatively in clinic, 39.3% gave the advice pre-operatively on the day of surgery, and 96.4% of responders based their advice on traditional teaching. Discussion and conclusions: There is variation in the content and timing of advice regarding driving after general surgical procedures. This inconsistency will undoubtedly lead to incorrect information being distributed to patients and will impact post-operative patient safety. We suggest formulating consistent advice in a written format, standardising the process which in turn will protect patients and surgeons.
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Sakai, R., E. Tanaka, M. Yamagishi, M. Majima, and M. Harigai. "POS0730 DECREASED RISK OF OSTEONECROSIS OVER TIME IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS USING JAPANESE HEALTH INSURANCE DATABASE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 615. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1484.
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Background:In patients with systemic lupus erythematosus (SLE), prevalence of osteonecrosis (ON) was 20–40% 1, and 4–10 times higher risk of ON than the general population was observed 2,3. Because ON can influence patients’ physical activity and quality of life, it is essential for rheumatologists to manage ON appropriately. Recently, medications such as mycophenolate mofetil (MMF) and hydroxychloroquine (HCQ) were approved for SLE in Japan. Considering the changes in treatments for SLE over time, it is clinically important to investigate the risk and risk factors of ON in patients with the disease. However, to date, only evidence is found in the literature.Objectives:To estimate incidence rate (IR) and identify risk factors of ON in patients with SLE using a Japanese health insurance database.Methods:This retrospective longitudinal population-based study was conducted using claims data provided by Medical Data Vision Co., Ltd (Tokyo, Japan). We defined individuals as SLE cases if they met all of the following: 1) having at least one ICD10 code (M321 or M329); 2) having at least one prescription of oral corticosteroids (CS), methylprednisolone (mPSL) pulse therapy, immunosuppressive drugs (IS) (azathioprine, mizoribine, tacrolimus, MMF, cyclophosphamide, methotrexate), biologics (belimumab, rituximab) or HCQ between January 2010 and January 2017; 3) being 16 years old or over. The start of observation was defined by the first month in which cases met all of the above criteria. Patients were followed until the earliest of date of first ON, date of loss of follow-up, or the end of follow-up (December 2017). ON was defined when patients had at least one ICD code (M87.0, M87.1, M87.2, M87.3, M87.8, M87.9, M90.5) during the observation period. Patients were excluded if they had a previous diagnosis of ON during the first 3 months of the observation period. We defined baseline characteristics using the data in the month of starting observation, and calculated incidence rate (IR) in each year, adjusted relative risk (RR [95% CI]) of ON using a Poisson regression model, and adjusted odds ratio (OR [95% CI]) of risk factors of ON after adjusting for age and sex at baseline, and medications and comorbidities during the observation period using a logistic regression model.Results:In this study, 16,386 cases were included. The median age was 55 years and 81.3% were female. Median observation period was 33 months, and total observation period was 47,138 patient-years (PY). IR/1,000 PY of ON in each year from 2010 to 2017 was 13.2, 10.6, 11.0, 13.3, 13.1, 9.8, 8.5, and 7.3, respectively. Adjusted RR in each year from 2011 to 2017 compared to 2010 was 0.5 [0.2–1.4], 0.3 [0.1–0.9], 0.6 [0.3–1.4], 0.7 [0.3–1.6], 0.4 [0.2–0.8], 0.4 [0.2–0.8], and 0.3 [0.1–0.7], respectively. Adjusted OR was 1.22 [1.10–1.34] for younger age by decade, 1.41 [1.11–1.79] for male, 2.69 [1.52–4.76] for use of oral CS (> 0 and < 5 mg/day of prednisolone [PSL] equivalent dose versus no use), 2.21 [1.26–3.86] for oral CS (≥ 5 and < 10mg/day versus no use), and 1.25 [1.02–1.54] for dyslipidemia.Conclusion:Significant decrease in IR of ON after 2015 was observed in Japanese patients with SLE for the first time. Younger age, use of CS, and dyslipidemia were identified as significant risk factors of ON.References:[1]Rheumatology 2018;57(5):844-9.[2]BMJ Open. 2017;7(7):e016788.[3]Eur J Intern Med. 2016;35:e23-e4.Disclosure of Interests:Ryoko Sakai Speakers bureau: RS received fees from Bristol Myers Squibb Co., Ltd., Grant/research support from: Tokyo Women’s Medical University (TWMU), particularly the Division of Multidisciplinary Management of Rheumatic Diseases, Department of Rheumatology, has received unrestricted research grants from Ayumi Pharmaceutical Co.; Chugai Pharmaceutical Co., Ltd.; Eisai Co., Ltd., Nippon Kayaku Co., Ltd.; Taisho Toyama Pharmaceutical Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Co.; and Teijin Pharma Ltd., with which TWMU paid the salaries of RS., Eiichi Tanaka Speakers bureau: ET has received lecture fees from Abbvie, Asahi Kasei pharma co., Astellas Pharmaceutical, Ayumi Pharmaceutical, Chugai Pharmaceutical, Eisai Pharmaceutical, Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kyowa Pharma Chemical CO.,LTD., Janssen Pharmaceutical K.K., Mochida Pharmaceutical CO.,LTD., Pfizer, Takeda Pharmaceutical, and Teijin Pharma Ltd., Consultant of: ET has received lecture fees from Abbvie, Asahi Kasei pharma co., Astellas Pharmaceutical, Ayumi Pharmaceutical, Chugai Pharmaceutical, Eisai Pharmaceutical, Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kyowa Pharma Chemical CO.,LTD., Janssen Pharmaceutical K.K., Mochida Pharmaceutical CO.,LTD., Pfizer, Takeda Pharmaceutical, and Teijin Pharma Ltd., Miku Yamagishi: None declared, masako majima: None declared, masayoshi harigai Speakers bureau: MH has received speaker’s fee from AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co.,Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd., Consultant of: MH is a consultant for AbbVie, Boehringer-ingelheim, Bristol Myers Squibb Co., Kissei Pharmaceutical Co., Ltd. and Teijin Pharma., Grant/research support from: MH has received research grants from AbbVie Japan GK, Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Daiichi-Sankyo, Inc., Eisai Co., Ltd., Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., Sekisui Medical, Shionogi & Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd.
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Zeng, X., X. Leng, K. Wei, W. M. Tang, C. H. Tang, K. Tunceli, J. Aggarwal, et al. "FRI0428 RESULTS FROM A CROSS-SECTIONAL, OBSERVATIONAL STUDY TO ASSESS INADEQUATE PAIN RELIEF IN PATIENTS WITH KNEE AND/OR HIP OSTEOARTHRITIS IN CHINA." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 812.1–813. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5813.
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Background:Osteoarthritis (OA) of the knee and hip is a leading cause of disability worldwide, particularly due to the primary symptom of pain in the weight-bearing joints. There is limited data that characterizes patients who experience moderate to severe pain despite analgesic treatment in China.Objectives:This study estimates the real-world prevalence of inadequate pain relief (IPR) among patients with knee and/or hip OA who have been prescribed analgesic therapy and characterizes this patient population. The study was conducted in China, the Philippines, Thailand, Russia, and Mexico. This abstract presents results from China.Methods:This is a multinational, multi-site, cross-sectional, observational study. Physicians managing patients with OA were recruited and asked to enroll patients over 50 years of age with knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit. Patients completed a one-time assessment of pain, function, and health-related quality of life (HRQOL) using patient reported outcome (PRO) instruments. Physicians abstracted data from patient charts. IPR was defined as an average pain score of >4/10 on Brief Pain Inventory Question #5 (average pain). Statistical tests including chi-square for categorical variables and Mann-Whitney Wilcoxon test for continuous variables were conducted to assess differences in demographic and clinical characteristics as well as PROs between patients with and without IPR. A multivariate regression analysis was conducted to assess the relationship between IPR and PROs.Results:571 patients treated at 10 hospital centers in China were enrolled. 73% were female, the mean (SD) age was 62 (8.32) years. The number of years with OA ranged from less than one year to over 37 years, suggesting a broad sample of patients. Most patients were impacted by knee OA only (90%). Almost half (43%) of the study population met the definition of IPR. Patients with IPR tended to be older, have greater prevalence of obesity, have more comorbidities, and had longer disease duration. The majority (98%) of patients were receiving nonsteroidal anti-inflammatory drugs (NSAIDS), followed by chondroprotective medications (23%). However, more patients with IPR mentioned being dissatisfied with treatment (38% vs. 21%). After adjusting for covariates, patients with IPR reported worse HRQOL, more functional limitations, and reduced work productivity compared to patients without IPR.Conclusion:IPR is highly prevalent among individuals with knee and/or hip OA in China and is associated with decreased HRQOL and work productivity, impaired function, and treatment dissatisfaction. Developing awareness among healthcare professionals about the presence and potential impact of IPR is important for the ultimate improvement of OA patient management.PROmean (SE)No IPR(N=328)IPR(N=243)EQ-5D Index0.72 (0.01)0.49 (0.02)EQ-5D VAS72.3 (0.85)65.5 (1.00)WOMAC Pain Subscale13.1 (0.78)22.7 (1.52)WOMAC Stiffness Subscale4.2 (0.27)7.4(0.51)WOMAC Physical Function Subscale44.8 (2.61)76.9 (5.07)Work Productivity Loss30.0 (4.07)47.5 (10.46)Multivariate analysis adjusted for age, year since OA diagnosis/follow-up, gender, BMI, number of medication classes, insurance, physician specialty/academic responsibilities, number of affected joints, diabetes, CVD, hyperlipidemia/hypertension, and depression. All differences were statistically significant (p < 0.05) except work productivity loss (p=0.11)Disclosure of Interests:Xiaofeng Zeng Consultant of: MSD Pharmaceuticals, Xiaomei Leng Consultant of: MSD Pharmaceuticals, Knightley Wei Employee of: Employed by MSD Pharmaceuticals (China), Wen Min Tang Employee of: Employed by MSD Pharmaceuticals (China), Cai Hua Tang Employee of: Employed by MSD Pharmaceuticals (China), Kaan Tunceli Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Jyoti Aggarwal Consultant of: Merck & Co., Inc., Dena Ramey Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Fidel Lozano Employee of: Merck & Co. salaried employee, Ishita Doshi Shareholder of: Holds company stock at Merck Sharp & Dohme Corp., Employee of: Employed by Merck Sharp & Dohme Corp., Cynthia Macahilig Consultant of: Consultant to Merck Sharp & Dohme Corp., Shardul Odak Consultant of: Consultant to Merck Sharp & Dohme Corp., Kelly Johnson Employee of: Employed by Merck & Co., Inc.
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Seymour, Erlene K., Lucius Daniel, Eva Pointer, Stephen T. Smith, and Charles A. Schiffer. "High Dependence on Medicare and Foundation Grant Assistance Among Patients with Hematologic Malignancies Receiving Novel Oral Therapeutics." Blood 134, Supplement_1 (November 13, 2019): 64. http://dx.doi.org/10.1182/blood-2019-128905.
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Introduction: Oral novel therapeutics place a high financial burden on patients. A specialty pharmacy at Karmanos Cancer Institute (KCI) was established which streamlines prior authorization, determines patient cost-sharing, then automatically applies for additional financial assistance (through co-pay cards or foundation grant funding as needed) prior to setting final patient cost-sharing and drug delivery. We evaluated patterns of cost and need for additional funding since this program was established. Methods: We used the KCI Specialty Pharmacy dataset for a retrospective review of patients who received prescriptions for hematologic malignancies between March 2018 - May 2019. Oral therapeutics >$10,000/month average wholesale price were considered high cost. We evaluated patients by drug prescribed and insurance type (Medicare, Medicaid, Private) and gathered information on insurer cost, final patient cost-sharing, cost covered by foundation grant assistance (if needed), and cost covered by manufacturer co-pay cards (if needed). We also calculated time in days from prescription written date to date of prior authorization, as well as prescription written date to date of delivery to the patient for all new first-time prescriptions. Results: 214 prescriptions among 100 patients were available for analysis. 2 of these patients switched insurance types. Drugs that were evaluated included imatinib, dasatinib, bosutinib, nilotinib, ponatinib, ruloxitinib, venetoclax, acalabrutinib, ibrutinib, ixazomib, midostaurin, gilteritinib, everolimus (for relapsed Hodgkin lymphoma), vorinostat, and enasidenib. The majority of patients had Medicare +/- supplemental insurance (52%), followed by private insurance (33%), and Medicaid (17%). Among all patients, 35% required additional financial assistance (for 75 claims). Most of these were through foundation grant funding (26% of all patients, 59 claims) and the remaining through manufacturer co-pay cards (9% of all patients, 16 claims). Medicaid patients did not require additional financial aid and have low cost-sharing given cost-sharing subsidies provided by Medicaid. Most of the patients requiring financial assistance were Medicare patients receiving foundation grant funding (Table). There were 10% of patients who did not receive additional assistance, but had high cost-sharing exceeding $100/prescription (range $295-$3514). Claims costs for all prescriptions totaled just over $2,000,000. The majority of the cost was paid by insurers with more than half covered by Medicare, ~$52,950 paid by foundation grant assistance, ~$8,486 paid by manufacturer co-pay cards, and $23,818 by patient cost-sharing. There were 105 first-time prescriptions to evaluate. When comparing the times required for prior authorization and delivery of drugs to patients, median times were similar by insurance type (Table), and most prescriptions received prior authorization approval within 1 day and were delivered within 7 days. Conclusions: Financial assistance was needed for 35% of all patients on novel therapeutics, mostly through foundation grant assistance. Medicare covered half of total 2 million dollar cost. Medicare patients bear the most burden, with 40% requiring foundation grant assistance, and 19% acquiring high co-pays. The KCI Specialty Pharmacy attained a total of ~$61,433 in financial assistance, and provided an efficient process for fast authorization and drug delivery which did not vary by insurance type or need for grants. Disclosures Smith: Genentech Advisory Council: Other: Pharmacy Consultant.
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Weiler, M., O. Schieir, M. F. Valois, S. J. Bartlett, L. Bessette, G. Boire, G. Hazlewood, et al. "SAT0127 REAL-WORLD PREDICTORS OF STARTING DIFFERENT ADVANCED DMARD TREATMENTS IN RHEUMATOID ARTHRITIS: A PROSPECTIVE INVESTIGATION FROM THE CANADIAN EARLY ARTHRITIS COHORT (CATCH) GROUP." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 999–1000. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2063.
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Background:RA patients with inadequate DMARD response may be treated with a TNF inhibitor (TNFi), non-TNFi or janus kinase inhibitor (JAKi) [1].Objectives:Compare characteristics of real-world early RA (ERA) patients starting TNFi, non-TNFi, and JAKi post DMARD failure.Methods:Data were analyzed from early RA patients (symptoms < 1 year) enrolled in CATCH who started TNFi, non-TNFi or JAKi as first line advanced therapy from 2014 to 2019. Descriptive statistics, t-tests and chi-square tests summarized and compared secular trends and patient characteristics initiating each class of therapy. Multinomial logistic regression analyses were done.Results:246 participants started advanced therapy during the study period; (75%) female, mean(SD) age 50(14) years. First line prescriptions for JAKi increased and TNFi decreased (Fig. 1). Those receiving JAKi had longer disease duration, fewer tender joints, and lower DAS28, CDAI, ESR, MD global (all p <0.05) (Table 1). The strongest predictor of starting JAKi was province (Ontario where access is preferential for JAKi and biosimilar TNFi) (Table 2). Those prescribed TNFi had shorter disease duration, younger age, fewer comorbidities, and treatment location outside Ontario (Table 1,2). Those starting non-TNFi had higher DAS28; predictors included older age, higher education, and more comorbidities (Table 1,2).Table 1.Characteristics prior to starting advanced therapyVariableTotal Sample(N = 246)JAKi(N = 61)TNFi(N = 153)Non-TNFi(N = 32)p-value£Disease duration (months) mean (SD)39 (34.1)50.8 (39.3)32.5 (29.1)48 (38.6)0.0006DAS28 (ESR - CRP if ESR was missing) mean (SD)4.2 (1.4)3.6 (1.4)4.3 (1.4)4.8 (1.5)0.0012CDAI mean (SD)21.5 (14.8)16.5 (13.7)22.9 (14.8)24.8 (14.9)0.0089Tender joint count (0-28), median (IQR)§4 (7)2 (6)5 (8)6 (9)0.0224ESR median (IQR)§13 (20)12 (13)13 (20)28.0 (23.5)0.0448MD Global (0-10) mean (SD)4.2 (2.7)3.2 (2.7)4.4 (2.6)4.8 (2.8)0.0030§IQR: 75 – 25 percentile£p-value: ANOVA for continuous variable, chi-square for categoricalTable 2.Multinomial regression for initiating advanced DMARD therapyDisease stage & Clinical Disease ActivityAdvanced DMARDAdjusted for Age, sex, education, comorbidityFullyAdjustedφNon-TNF vs TNFJAK vsTNFNon-TNF vs TNFJAK vsTNFAge1.01 (0.98, 1.05)1.01 (0.99, 1.04)1.01 (0.97, 1.05)1.02 (0.99, 1.05)Women vs Men1.98 (0.71, 5.58)1.33 (0.63, 2.80)2.35 (0.76, 7.27)1.72 (0.73, 4.02)Education(< HS vs ≥ HS)2.92 (1.28, 6.63)1.49 (0.78, 2.86)2.83 (1.12, 7.15)2.08 (0.97, 4.47)RDCI baseline1.35 (1.01, 1.81)1.21 (0.95, 1.53)1.30 (0.95, 1.78)1.23 (0.94, 1.60)Private Insurance(No vs Yes)NINI1.26 (0.47, 3.40)0.99 (0.44, 2.25)RF PositiveNINI1.47 (0.56, 3.85)1.84 (0.82, 4.12)CDAININI1.01 (0.98, 1.04)0.97 (0.94, 1.00)RegionQuebec vs Ontario (ON)NINI0.59 (0.20, 1.72)0.44 (0.20, 0.94)West vs ONNINI1.32 (0.29, 5.98)0.11 (0.01, 0.99)φAdjusted for; baseline age, sex, education, RDCI; province; RF positive in first year; private insurance; CDAI at visit prior to initiationConclusion:Patient and physician related factors (location of practice) determined which advanced therapeutic was prescribed. JAKi use is increasing in ERA.Reference:[1]Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases Published Online First: 22 January 2020Disclosure of Interests:Madina Weiler: None declared, Orit Schieir: None declared, Marie-France Valois: None declared, Susan J. Bartlett Consultant of: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Speakers bureau: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Gilles Boire Grant/research support from: Merck Canada (Registry of biologices, Improvement of comorbidity surveillance)Amgen Canada (CATCH, clinical nurse)Abbvie (CATCH, clinical nurse)Pfizer (CATCH, Registry of biologics, Clinical nurse)Hoffman-LaRoche (CATCH)UCB Canada (CATCH, Clinical nurse)BMS (CATCH, Clinical nurse, Observational Study Protocol IM101664. SEROPOSITIVITY IN A LARGE CANADIAN OBSERVATIONAL COHORT)Janssen (CATCH)Celgene (Clinical nurse)Eli Lilly (Registry of biologics, Clinical nurse), Consultant of: Eli Lilly, Janssen, Novartis, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Glen Hazlewood: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant of: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion,Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, LillyPharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Diane Tin: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Vivian Bykerk: None declared, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB
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Farber, Charles M., Anthony Mato, Chadi Nabhan, Thomas J. Kipps, Christopher Flowers, Neil E. Kay, Nicole Lamanna, et al. "Analysis of Early Mortality of Chronic Lymphocytic Leukemia (CLL) Patients Treated in US Practices in the Connect CLL® Registry." Blood 126, no. 23 (December 3, 2015): 5270. http://dx.doi.org/10.1182/blood.v126.23.5270.5270.
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Abstract Introduction The natural history of patients (pts) with CLL varies considerably. Some pts may have asymptomatic, indolent disease, while others may require therapy soon after diagnosis. Clinical staging systems cannot identify early-stage pts at risk for inferior survival. Genetic and molecular markers can provide additional information regarding prognosis and response prediction, however their utilization is limited in routine practice (Mato, ASCO 2015) and results can be conflicting. There is a need to identify characteristics of early-stage CLL pts at highest risk of early progression and/or death. Such characteristics, if readily available and reproducible, may identify such pts as candidates for early-intervention studies; particularly in the era of kinase inhibitor therapy. The Connect CLL registry is the largest prospective study describing real-world management of a diverse cohort of 1494 CLL pts. In this analysis, we evaluate key factors that are associated with early CLL-associated mortality in clinical practice. Methods Connect CLL is a multicenter, observational cohort study aimed at understanding patterns of CLL management without a study-specific intervention. Eligible pts were adults with a clinical diagnosis of CLL, enrolled between 2010-2014 at 179 community (n=1311), 17 academic (n=155), and 3 government (n=28) sites within ≤ 2 months of initiating either a first line of therapy (LOT1), or a second-line or subsequent LOT (LOT≥2). The goal of this analysis was to assess potential predictors of death occurring within 18 months following initiation of frontline therapy (LOT1). Because CLL usually presents as an indolent disease associated with a prolonged clinical course, we chose to define early mortality as any death occurring ≤ 18 months following enrollment. Univariate logistic regression was performed against potential predictor variables including several clinical characteristics and comorbid conditions, race, treatment (Tx) site, insurance type, geographic region, presence of prior malignancies, genetic prognostic factors (FISH and cytogenetics) at enrollment, cell surface markers (Zap70, CD38), reasons for Tx initiation and Tx choice for LOT1 (BR or FCR). IgVH mutation status and genetic mutations (P53, Notch1, etc.) were not included as these tests were not readily performed in community practice. Predictors that were found to be significant at the 0.15 significance level were included in the multivariable logistic regression using a stepwise variable selection process, to identify factors associated with early mortality. Results 1344 pts completed 18 months of follow-up (n=1111) or died (n=233) within the first 18 months of study enrollment. Of these, 801 pts were enrolled in LOT1 (median time from diagnosis to LOT1 was 1.3 yrs; IQR, 0.1-3.7 yrs). 82 of 801 pts (10.2%) died within 18 months of LOT1 initiation; 41% of pts with available clinical information who died, were defined as early-stage (Rai stage 0-1). Of 26 potential predictors evaluated, 12 were associated with early mortality among LOT1 pts at the 0.15 significance level in univariate analyses including site, race, age>75, CD-38, del(17p), ECOG PS, CCI group, RAI stage, creatinine clearance, insurance status, reasons for Tx initiation, anemia and lymphocytosis. In multivariable logistic regression analyses we identified 4 independent predictors of mortality within 18 months of LOT1 initiation (Table): pt age, CD38 expression, baseline decreased hemoglobin (as a reason for Tx initiation), and race. Conclusions In CLL pts with Rai stage 0-1, we have identified 4 factors which are associated with increased risk of death within 18 months of initiation of frontline therapy. Interestingly, neither choice of FCR vs BR chemoimmunotherapy nor the presence of del(17p)/del(11q) were predictors of early mortality. Using these results, we are currently designing a model to predict early mortality in early-stage pts. Once validated, these results may provide a framework for trials targeting the "early stage, symptomatic" CLL pts for novel interventions. Table. Multivariable Analysis: Predictors of Early Mortality Odds ratio estimate 95% CI P -value LOT1, n=781 Age ≥75 years, yes vs no 2.2 1.4-3.5 0.0012 CD38 expression, positive vs negative/not specified 1.8 1.1-2.9 0.0182 Anemia as reason for treatment, yes vs no 2.1 1.3-3.4 0.0040 Race, other vs Caucasian 1.9 1.0-3.8 0.0501 Disclosures Farber: Gilead: Speakers Bureau; Genentech: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Pharmacyclics: Honoraria, Speakers Bureau. Mato:TG Therapeutics: Research Funding; Genentech: Consultancy; AbbVie: Consultancy, Research Funding; Pronai Pharmaceuticals: Research Funding; Gilead: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Celgene Corporation: Consultancy, Research Funding; Janssen: Consultancy. Nabhan:Celgene Corporation: Honoraria, Research Funding. Kipps:Pharmacyclics Abbvie Celgene Genentech Astra Zeneca Gilead Sciences: Other: Advisor. Flowers:Spectrum: Research Funding; Pharmacyclics: Research Funding; Infinity Pharmaceuticals: Research Funding; OptumRx: Consultancy; Gilead Sciences: Research Funding; Spectrum: Research Funding; Genentech: Research Funding; Onyx Pharmaceuticals: Research Funding; Acerta: Research Funding; OptumRx: Consultancy; Gilead Sciences: Research Funding; AbbVie: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Consultancy; Onyx Pharmaceuticals: Research Funding; Genentech: Research Funding; Millennium/Takeda: Research Funding; Celegene: Other: Unpaid consultant, Research Funding; Janssen: Research Funding; Infinity Pharmaceuticals: Research Funding; Acerta: Research Funding; AbbVie: Research Funding; Seattle Genetics: Consultancy; Celegene: Other: Unpaid consultant, Research Funding; Janssen: Research Funding; Millennium/Takeda: Research Funding. Kay:Pharmacyclics: Research Funding; Hospira: Research Funding; Genentech: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Tolero Pharma: Research Funding; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding. Lamanna:Genentech-Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Infinity: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Grinblatt:Celgene Corporation: Consultancy, Honoraria, Speakers Bureau. Kozloff:Celgene: Consultancy, Speakers Bureau; Genentech: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; AbbVie: Consultancy. Sullivan:Celgene Corporation: Employment, Equity Ownership. Flick:Celgene Corporation: Employment, Equity Ownership. Kiselev:Celgene Corporation: Consultancy. Bhushan:Celgene Corporation: Employment, Equity Ownership. Swern:Celgene Corporation: Employment, Equity Ownership. Sharman:TG Therapeutics, Inc.: Research Funding; Celgene Corporation: Consultancy, Research Funding; Gilead: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Research Funding; Calistoga: Honoraria; Roche: Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding.
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Sharara, Sima L., Sara E. Cosgrove, Sara E. Cosgrove, Alicia Arbaje, Ayse P. Gurses, Kate Dzintars, and Sara C. Keller. "1063. A Healthcare Worker-Informed Approach to the Hospital-to-Home Transition on Oral Antibiotics." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S376. http://dx.doi.org/10.1093/ofid/ofz360.927.
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Abstract Background Improved antibiotic decision-making during the hospital-to-home transition is an important but under-addressed target for antimicrobial stewardship. This study aims to provide a healthcare worker-informed approach to characterize prescriber antibiotic decision-making and patient medication management at discharge to identify barriers to and strategies for antibiotic stewardship during the hospital-to-home transition. Methods Semi-structured interviews were conducted at an academic medical center with relevant stakeholders including house staff (n = 10), nurses (n = 2), nurse practitioners (n = 5), inpatient pharmacists (n = 4), and discharge coordinators (n = 2). Interviews focused on challenges to antibiotic decision-making and patient medication management at discharge. Transcripts were independently coded and analyzed by two physicians using the constant comparative method. Results We identified four main barriers to antibiotic decision-making at hospital discharge: (1) uncertainty over antibiotic choice (due to lack of microbiology data), (2) pressure to discharge, (3) lack of control over antibiotic decision-making (attending-led decision with little room for input), and (4) lack of awareness of cost and insurance coverage. We also identified challenges to patient medication management specific to patient education: (1) role ambiguity around who provides education and (2) lack of education to patients around side effects. To improve antibiotic decision-making, prescribers relied heavily on institutional guidelines and interaction with experts in informing antibiotic choices, and used multidisciplinary approaches to verify antibiotic cost and availability. Five strategies to improve medication management were proposed: (1) assessing patient health literacy when providing instructions, (2) an in-hospital trial of the oral antibiotic to ensure tolerance, (3) ensuring the patient leaves the hospital with the antibiotic in hand, (4) care coordination after discharge, and (5) close follow-up with prescribers after discharge. Conclusion Our findings identify barriers to discharge antibiotic decision-making and medication management that allow for targeted interventions to improve antibiotic decision-making during the hospital-to-home transition. Disclosures Sara E. Cosgrove, MD, MS, Basilea: Consultant; Theravance: Consultant.
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Sakai, R., E. Tanaka, M. Majima, and M. Harigai. "FRI0075 DECREASED RISKS OF HOSPITALIZED INFECTION UNDER TARGETED THERAPIES VS METHOTREXATE IN ELDERLY AND OLDER ELDERLY PATIENTS COMPARED TO YOUNGER PATIENTS WITH RHEUMATOID ARTHRITIS USING JAPANESE HEALTH INSURANCE DATABASE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 614–15. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1913.
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Background:Recently, vital prognosis has been improved in patients with rheumatoid arthritis (RA)1. In elderly patients, it is difficult to establish a treatment strategy due to multi-morbidities and treatment-related risks. Since older age is a significant risk factor of serious infections, one of the primary concerns during treatment of RA, rheumatologists should always strike a balance between efficacy and safety of the immunosuppressive treatment. However, infection data under the targeted therapy (TT) in elderly patients is still limited to date.Objectives:To compare the risk of hospitalized infection (HI) under the TT among young, elderly, and older elderly patients with RA using the Japanese health insurance database.Methods:This retrospective longitudinal population-based study was conducted using claims data in Japan provided by Medical Data Vision Co., Ltd. We defined individuals as RA cases if they met all of the following: 1) having at least one ICD10 code (M05x, M06x except for M061, or M08x except for M081 and M082); 2) having at least one prescription of disease-modifying antirheumatic drugs (DMARDs) including methotrexate (MTX) and TT (biological DMARDs and Janus kinase inhibitors) between April 2008 and September 2018; and 3) 16 years old or older. We define the month patients met the above all criteria for the first time in this database as the index month. We excluded patients who were prescribed any DMARDs during the first 12 months from MTX users and those with prescription of any TT during the first 12 months from TT users (i.e., prevalent users). Among the study population, we divided patients into 3 groups according to their age at the index month; young group (16-64), elderly group (65-74), and older elderly group (>=75). The observation started from the index month and ended at 36 months later, the last month of the exposure of DMARDs, the month of loss of follow-up, or September 2019, whichever came first. HI was defined by ICD10 code with one prescription of predefined drugs for each infection during hospitalizations. Some of HIs were defined by ICD10 code alone.Results:In this study, 8269, 6454, 5745 patients with RA were included in the young, elderly, and older elderly groups, respectively. The incidence rate (IR) of HI (/100 patient-years [PY]) [95%CI] was 3.4 [3.1-3.7] in the young group, 5.8 [5.3-6.3] in the elderly group, and 12.0 [11.2-12.8] in the older elderly group. IR rate (IRR) of HI (reference: the young group) was 1.7 [1.5-1.9] in the elderly group and 3.6 [3.2-4.0] in the older elderly group. In the young group, the IRR of HI in TT users vs MTX users was significantly elevated (1.8 [1.5-2.1]), whereas, those of the elderly and the older elderly groups were significantly decreased (IRR 0.8 [0.7-0.9] for elderly; 0.6 [0.5-0.7] for older elderly). Concomitant use of immunosuppressive DMARDs or prednisolone >=10mg/day with TT became less frequent with aging.Conclusion:The elderly and older elderly patients had significantly higher risks of HI compared to the young. The risk of HI under the TT compared to MTX was decreased in the elderly patients, probably due to adjusting for treatment by attending physicians.References:[1]Arthritis Rheum 2014;66:786-93Acknowledgments:This work was supported by JSPS KAKENHI Grant Number 17K08963.Disclosure of Interests:Ryoko Sakai Grant/research support from: Tokyo Women’s Medical University (TWMU) has received unrestricted research grants forDivision of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases from Ayumi Pharmaceutical Co. Ltd., Bristol Meyers Squib, Chugai Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corp., and with which TWMU paid the salary of R.S., Eiichi Tanaka Consultant of: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., Speakers bureau: ET has received lecture fees or consulting fees from Abbvie, Asahi Kasei pharma co., Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo Co., Eisai Pharmaceutical, Janssen Pharmaceutical K.K., Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical Co., and UCB Pharma., masako majima: None declared, masayoshi harigai Grant/research support from: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., and Teijin Pharma Ltd. MH has received speaker’s fee from AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Oxford Immuotec, Pfizer Japan Inc., and Teijin Pharma Ltd. MH is a consultant for AbbVie, Boehringer-ingelheim, Kissei Pharmaceutical Co., Ltd. and Teijin Pharma.
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Vladzymyrskyy, A. V. "Matrix for direct-to-consumer telemedicine quality assessing." Journal of Telemedicine and E-Health 6, no. 4 (December 30, 2020): 24–44. http://dx.doi.org/10.29188/2542-2413-2020-6-4-34-44.
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Introduction. The growing demand for online medical services, the active inclusion of telemedicine consultations in state health insurance programs, and the general intensive development of telemedicine require a methodology for quality assurance and control. Objective is to develop a methodological basis for a comprehensive assessment of the quality and effectiveness of direct-to-consumer telemedicine consultations. Material and methods. There are sources of primary data: systematizing scientific publications (descriptions of models and methodologies for telemedicine quality assessing); own theoretical researches, accumulated practical experience with of directto-consumer telemedicine. Methods of analysis and synthesis have been use. Results and discussion. The matrix for for direct-to-consumer telemedicine quality assessing has formed. It includes four domains «Accessibility», «Efficiency», «Safety» and «Responsibility» from the standpoint of all participants of the distant interaction processes: patient and/or legal representative; medical consultant; operator of a telemedicine information system; medical organization; health care system (society). The matrix takes into account the aspects of goal-setting and the interests of each participant. There are structured metrics in frame of each domain. Conclusions. The matrix can be used as a basis for scientific research and as a methodology for internal and departmental quality control of medical care provided via telemedicine technologies.
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Alpesh, Amin N., Allison Keshishian, Lin Xie, Onur Baser, Kwanza Price, Lien Vo, Prianka Singh, et al. "Early Comparison of Major Bleeding, Stroke and Associated Medical Costs Among Treatment-Naive Non-Valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin." Blood 126, no. 23 (December 3, 2015): 745. http://dx.doi.org/10.1182/blood.v126.23.745.745.
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INTRODUCTION: Recent large randomized controlled trials have shown that novel oral anticoagulants (NOACs) are at least as effective as warfarin for risk reduction of stroke or systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and are associated with similar or lower rates of bleeding.1,2,3,4 The study aimed to compare real-world major bleeding and stroke risk reduction and their related medical costs following initiation of apixaban compared to other oral anticoagulants (OACs) among treatment-naïve NVAF patients. METHODS: From a large national commercial and Medicare advantage insurance database, adult patients initiating apixaban, dabigatran, rivaroxaban, or warfarin (01/01/2013-12/31/2014) were identified. The OAC prescription date was designated as the index date. Patients were required to have an AF diagnosis (ICD-9-CM: 427.31) and continuous health plan enrollment for 6 months pre-index date. Patients with evidence of mitral valvular heart disease, valve replacement procedures, pregnancy, or OAC claims before the index date were excluded. Patients were classified into four cohorts based on their index prescription: apixaban, dabigatran, rivaroxaban and warfarin. Time-to- first stroke and major bleeding events, identified by the Cunningham algorithm plus additional bleeding sites, were compared using a Cox proportional hazards model. Major bleeding and stroke-related medical costs including those for recurring events were calculated per patient per month (PPPM) and compared using propensity-weighted generalized linear models. RESULTS: The study included 5,573 apixaban, 4,104 dabigatran, 13,370 rivaroxaban, and 25,978 warfarin patients. Apixaban patients had significantly higher CHA2DS2-VASc (3.6) and HAS-BLED (2.4) scores compared to dabigatran (CHA2DS2-VASc=3.3, HAS-BLED=2.2; p<0.001) and rivaroxaban (CHA2DS2-VASc=3.3, HAS-BLED=2.3; p<0.001) patients but lower scores compared to warfarin patients (CHA2DS2-VASc=4.0, HAS-BLED=2.7; p<0.001). After adjusting for baseline characteristics, apixaban patients were significantly less likely to have the first major-bleeding event within 1 year of treatment initiation compared to rivaroxaban (HR=0.71; 95% CI=0.62-0.82), warfarin (HR=0.71; 95% CI=0.62-0.80) patients, and trended towards numerically lower risk compared to dabigatran (HR=0.87; 95% CI=0.74-1.03) patients. Furthermore, apixaban patients were 26% less likely to have the first stroke within 1 year of treatment initiation compared to warfarin patients (HR=0.74; 95% CI=0.68-0.81), and trended towards numerically lower risk compared to rivaroxaban (HR=0.94; 95% CI=0.86-1.04) and dabigatran (HR=0.91; 95% CI=0.81-1.02) patients. Major bleeding-related medical costs were lower in apixaban patients compared to rivaroxaban ($85, p<0.001) and warfarin ($122, p<0.001) patients. The stroke-related medical costs were not significantly different; however, patients treated with apixaban had numerically lower PPPM stroke-related costs ($46) compared to those treated with rivaroxaban ($51) and warfarin ($68). CONCLUSION: In a large insured population, treatment-naïve NVAF patients treated with apixaban were significantly less likely to have a major bleed compared to those prescribed rivaroxaban or warfarin and less likely to have a stroke compared to those prescribed warfarin. Additionally, patients prescribed apixaban had lower major bleeding costs compared to those prescribed rivaroxaban and warfarin. 1 Lip GYH, Halperin JL, Petersen P, Rodgers GM, Pall D, Renfurm RW. A phase II, double-blind, randomized, parallel group, dose-finding study of the safety and tolerability of darexaban compared with warfarin in patients with non-valvular atrial fibrillation: the oral factor Xa inhibitor for prophylaxis of stroke in atrial fibrillation study 2 (OPAL-2). J Thrombrosis Haemostasis. 2015;13:1405-13. 2 O'Donoghue ML, Ruff CT, Giugliano RP, et al. Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation. Eur Heart J. 2015;36(23):1470-7. 3 Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013;368(8):699-708. 4 Lanssen M, Raskob G, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): A randomized double-blind trial. Lancet 2010;375(9717):807-15. Disclosures Alpesh: Pfizer Inc.: Consultancy. Keshishian:Pfizer Inc.: Consultancy, Other: A. Keshishian is an employee of STATinMED Research, which is a paid consultant to Pfizer Inc.. Xie:Pfizer Inc.: Consultancy, Other: L. Xie is an employee of STATinMED Research, which is a paid consultant to Pfizer Inc.. Baser:Pfizer Inc.: Consultancy, Other: O. Baser is an employee of STATinMED Research, which is a paid consultant to Pfizer Inc.. Price:Pfizer Inc.: Employment. Vo:Bristol-Myers Squibb: Employment. Singh:Bristol-Myers Squibb: Employment. Bruno:Bristol-Myers Squibb: Employment. Mardekian:Pfizer Inc.: Employment. Tan:Pfizer Inc.: Employment. Singhal:Bristol-Myers Squibb: Employment. Patel:Bristol-Myers Squibb: Employment. Odell:Pfizer Inc.: Employment. Trocio:Pfizer Inc.: Employment.
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Isnardi, C. A., E. E. Civit De Garignani, A. García Ciccarelli, J. Sanchez Alcover, R. Garcia Salinas, S. Magri, E. Albiero, et al. "AB0214 SURVIVAL, EFFICACY AND SAFETY OF GOLIMUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS AND SPONDYLOARTHRITIS: DATA FROM AN ARGENTINEAN COHORT." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1133–34. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1399.
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Background:Golimumab is a human monoclonal antibody directed against TNFα in its soluble and transmembrane forms. It can be used subcutaneously or intravenously and has shown efficacy for use in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).Objectives:The aim of this study was to evaluate the efficacy, safety, and cumulative survival of golimumab in patients with RA, PsA and AS from different rheumatology centers in Argentina.Methods:We performed a longitudinal study of consecutive adults with RA (ACR/EULAR 2010 criteria), PsA (CASPAR criteria) and AS (ASAS 2009 criteria), who have started treatment with subcutaneous or intravenous golimumab according to medical indication in each center. Data was obtained by review of medical records. Sociodemographic and clinical data, musculoskeletal manifestations, comorbidities, previous treatments were recorded. In reference to golimumab treatment, start date, route of administration and concomitant treatments were identified. Disease activity was assessed using DAS28 for RA patients, DAPSA and MDA for PsA and BASDAI for AS. The presence of adverse events (AE) was recorded. If golimumab was stopped, date and cause was documented. Patients were followed up until golimumab discontinuation, loss of follow-up, or study completion (November 30, 2020). Statistical analysis: Chi2 test or Fischer exact test and T test or Mann Whitney and ANOVA or Kruskal Wallis, as appropriate. The incidence of EA was assessed in events every 100 patient/year. Kaplan-Meier curves and log Rank analysis. Cox proportional regression.Results:One hundred eighty two patients were included, 116 with a diagnosis of RA, 30 with PsA and 36 with AS. Most of them (70.9%) were female with a median (m) age of 55 years (IQR 43.8-64) and m disease duration of 7 years (IQR 4-12.7) at treatment initiation. Al least one prior biological DMARD or a small molecule was received by 63 patients (34.6%). The most frequent indication cause was conventional DMARD failure. In 94.8% of the patients Golimumab was administered subcutaneously, and in 80.8% in association with conventional DMARDs, the most frequently used was methotrexate. Total follow-up was 318.1 patients/year.Golimumab treatment showed clinical improvement in all three groups of patients. In RA patients DAS28 significantly decreased during the first 12 months of follow-up, m 5.9 (IQR 4.9-6.6) at baseline, 3.8 (IQR 2.6-4.6) at 6 months and 2.8 (IQR 2.1-3.6) at 12 months, p <0.0001. In PsA, m DAPSA-ESR value was 32.2 (IQR 24.2-47.7), 10.1 (IQR 5.8-18.3) and 11.2 (IQR 3.4-24) at baseline, 6 and 12 months, respectably (p <0.0001). In AS, m BASDAI was 6.2 (IQR 4.8-7.3), 2.8 (IQR 1.7-4.1) and 2.2 (IQR 1.1-3.2), at baseline, 6 and 12 months respectively (p <0.0001).The incidence of adverse events was 6.6 per 100 patients/year, being infections the most frequents ones. During follow-up, 50 patients (27.5%) discontinued golimumab, the most frequent cause was treatment failure (68%), followed by lack of health insurance (16%) and adverse events (10%). Golimumab persistence was 79% and 57.6% at 12 and 24 months, respectively. Treatment survival was 50.2 months (95% CI 44.4-55.9). Patients who had received prior treatment with biological DMARDs or small molecules showed lower survival (Figure 1). In the multivariate analysis, adjusting for age, sex and disease duration, those patients showed twice the risk of suspending treatment (HR 2.01, 95% CI 1.1-3.7).Figure 1.Golimumab survival according to prior b-DMARD o small molecule treatment.Conclusion:Golimumab treatment in real life patients in Argentina has shown good efficacy and safety. Drug survival was over 4 years and almost 80% were still using golimumab after one year. Prior treatment with other b-DMARDs o small molecules was associated with lower treatment survival.Disclosure of Interests:Carolina Ayelen Isnardi Speakers bureau: Bristol Myers Squibb, Janssen, Grant/research support from: Pfizer, Emma Estela Civit De Garignani Speakers bureau: Abbvie, Novartis, Agustín García Ciccarelli Speakers bureau: Janssen, Novartis, Consultant of: Novartis, Grant/research support from: Janssen, Novartis, Jimena Sanchez Alcover: None declared, Rodrigo Garcia Salinas Speakers bureau: Abbvie, AMGEN, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen Cilag, Montpellier-UCB, Novartis, Roche – Genentech, Sanofi, Merck Serono., Sebastian Magri Speakers bureau: Abbvie, AMGEN, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen Cilag, Montpellier-UCB, Novartis, Roche – Genentech, Sanofi, Merck Serono., Eduardo Albiero Consultant of: Janssen, Carla Gobbi Speakers bureau: Pfizer, Consultant of: Pfizer, Janssen, Edson Velozo Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: Abbvie, Janssen, Novartis, Grant/research support from: Janssen, Novartis, Pfizer, Enrique Soriano Speakers bureau: AbbVie, Novartis, Bristol MS, Novartis, Eli Lilly, Genzyme, Pfizer, Amgen, and Roche, Consultant of: Novartis, AbbVie, Pfizer, Eli Lilly, Sanofi, Sandoz, Amgen., Grant/research support from: Roche, Novartis, AbbVie, Glaxo Smith Kline, BMS, Martín Brom: None declared, Johana Zacariaz Grant/research support from: Bristol Myers Squibb, Ingrid Strusberg Speakers bureau: Gema Biotech SAU, BMS, Abbvie, Consultant of: Gema Biotech SAU, Abbvie, Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Marcos BARAVALLE Speakers bureau: Montepellier, Consultant of: Abbvie, Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Sol Castaños Speakers bureau: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Liliana Morales Speakers bureau: Lilly, Consultant of: Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Sergio Paira: None declared, Romina Calvo: None declared, Alberto Ortiz: None declared, Rodolfo Perez Alamino Speakers bureau: Pfizer, Abbvie, Amgen, Bristol-Myers-Squibb, Lilly, Janssen, Novartis, Hernan Maldonado Ficco Speakers bureau: Pfizer, Abbvie, Jansen, Novartis, Bago, Bristol, Eli Lilly., Consultant of: Pfizer, Abbvie, Novartis, Jansen, Bago, Eli Lilly., Gustavo Citera Speakers bureau: Abbvie, BMS, Lilly, Jansen, Gema, Pfizer, Roche, Grant/research support from: Pfizer
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Garrido-Cumbrera, M., D. Poddubnyy, C. Bundy, L. Christen, R. Mahapatra, S. Makri, C. J. Delgado-Domínguez, S. Sanz-Gómez, P. Plazuelo-Ramos, and V. Navarro-Compán. "POS0244 PATIENT JOURNEY WITH AXIAL SPONDYLOARTHRITIS: CRITICAL ISSUES FROM THE PATIENT PERSPECTIVE. RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 343.2–344. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2426.
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Background:The journey of axial spondyloarthritis (axSpA) for most patients is slow and arduous.Objectives:The goal of this analysis is to describe the journey to diagnosis and further management in axSpA patients.Methods:2,846 unselected patients participated in EMAS, a cross-sectional study (2017-2018) across 13 European countries. Descriptive analysis of sociodemographic factors, insurance scheme, diagnostic journey and post diagnosis healthcare utilization was performed. Mann-Whitey test was used to analyse possible differences between BASDAI (>4 v ≤4) and the number of visits to healthcare professionals and follow-up tests undertaken.Results:Mean age was 43.9 years, 61.3% were female, 48.1% university educated, 67.9% married, 53.9% employed and 81.7% had public health insurance. Mean age at symptoms onset was 26.6 (11.1), while mean age at diagnosis was 33.7 (11.5) and mean diagnostic delay was 7.4 years. Over 50% had a diagnostic delay of ≥4 years. Prior to receiving a diagnosis, patients visited on average 2.6 specialists. The most commonly performed diagnostic tests were x-rays (72.3%), HLA B27 tests (65.4%) and MRIs (64.3%). 78.4% were diagnosed by a rheumatologist while 14.9% received their diagnosis by a GP. Patients who experienced a diagnostic delay of more than a year (n= 2,208) undertook a considerable number of visits to specialists and medical tests in the year prior to participating in EMAS, which increased with disease activity. Patients with active disease (BASDAI >4) reported a higher number of visits to rheumatologists (3.7±3.5 vs 2.9±2.6), general practitioners (6.6±10.0 vs 3.5±4.1), physiotherapists (19.3±25.0 vs 11.7±17.0), and psychologists/psychiatrists (3.4±10.7 vs 1.9±7.7). Patients with active disease also undertook more x-rays (1.8±2.8 vs. 1.3±1.9), MRI scans (0.9±1.2 vs. 0.6±1.1), and blood tests (4.7±4.4 vs 3.6±3.2). However, one in five patients visited the rheumatologist only once in the year prior to EMAS (21.1%).Conclusion:Diagnostic delay continues to be a key challenge in the axSpA patient journey, with patients waiting an average of 7.4 years and visiting multiple doctors prior to diagnosis. Once diagnosed, disease management presents a further challenge, as patients with higher disease activity reported more healthcare professional visits as well as medical tests. Safeguarding health and controlling healthcare utilization requires effective disease management, greater education for non-specialists, rapid referral routes for diagnosis and collaborative care between specialists and non-specialists.Figure 1.axSpA Patient journey according to EMASAcknowledgements:This study was supported by Novartis Pharma AG. The authors would like to thank all participants who participated in this study.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Denis Poddubnyy Consultant of: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Abbvie, MSD, Novartis and Pfizer, Christine Bundy Consultant of: Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer, Laura Christen Employee of: Novartis Pharma AG, Raj Mahapatra: None declared, Souzi Makri: None declared, Carlos Jesús Delgado-Domínguez: None declared, Sergio Sanz-Gómez: None declared, Pedro Plazuelo-Ramos: None declared, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB
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Hayes, K., M. Panaccio, H. Zhou, and M. Fahim. "AB1166 DETERMINANTS OF REPOSITORY CORTICOTROPIN INJECTION TREATMENT INITIATION FOR PATIENTS WITH RHEUMATOID ARTHRITIS IN A LARGE CLAIMS DATABASE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1873.1–1874. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2329.
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Background:The treatment goal in rheumatoid arthritis (RA) is sustained remission and prevention of RA flares [1]. While targeted biologics have improved disease outcomes, almost one-third of patients (pts) discontinue treatment by 1 year and 50% by 2 years, with lack of efficacy as the most common reason [2]. Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides and is an agonist for all 5 melanocortin receptors (MCRs). Activation of MCRs by RCI has been shown to have direct and indirect anti-inflammatory and immunomodulatory effects. RCI is indicated for adjunctive therapy for short-term administration in RA flares or uncontrolled disease [3].Objectives:To characterize RA pts that initiate RCI therapy and identify predictors of RCI initiation, compared to biologic disease-modifying antirheumatic drugs (DMARDs).Methods:This retrospective cohort study identified pts with ICD-9/10 diagnosis for RA over an 11-year period (2008-2018) in a large claims database (Truven MarketScan®). Adults with ≥1 claim for RCI (RCI cohort) or ≥1 RA-related biologic claim but no RCI (non-RCI cohort) were selected and characterized by demographics, disease severity (Claims-based Index for RA Severity, CIRAS), comorbidities (Charlson Comorbidity Index, CCI), treatment patterns, and healthcare resource utilization in the 12-month baseline (BL) period prior to their index date (i.e., the 1stRCI claim or last claim for biologic for non-RCI cohort). Predictors of RCI initiation were identified by multivariable logistic regression, controlling for demographics and BL characteristics.Results:A total of 393 pts initiated RCI therapy while 188,062 initiated biologic treatment with no RCI claims. At BL, cohorts were similar with respect to mean age (~56 years), gender (76-79% female), and insurance type (79-80% commercial). Cohorts differed by region, plan type, and index year. Compared to non-RCI patients, the RCI cohort had significantly higher CCI and CIRAS scores; higher use of traditional DMARDs (65.6% vs. 61.9%), corticosteroids (CS, 91.3% vs 68.8%), prescription nonsteroidal anti-inflammatory drugs (NSAIDs, 66.9% vs 58.5%), and opioids (67.7% vs 47.5%), but lower biologic use (45.8% vs. 87.7%) (all p<0.05). RCI pts had significantly higher mean number of inpatient, emergency room, office, and outpatient visits (all p<0.05).RCI therapy initiation was most significantly impacted by treatment patterns, including number of DMARDs, CS, and opioids tried in the previous year (Figure 1). Corticosteroid use was the strongest predictor of RCI initiation, especially extended use at any dose (OR≥2.6) and extended use of the highest doses (>15 mg/day, OR=8.5), present in 21% of the RCI cohort (Figure 1). Drug benefit generosity (proportion of out-of-pocket costs) was also associated with RCI initiation in any plan qualified as better than “below average” (OR=2.1-2.9). Anemia, renal disease, and Sjogren’s syndrome were also associated with higher odds of RCI initiation (OR=1.4-2.1).Conclusion:RA pts initiating RCI therapy were prescribed a greater number of traditional DMARDs, CS, and opioids in the previous 12 months compared to non-RCI pts, and have evidence of more severe disease and comorbidities. Extended and high dose CS use were the factors most associated with RCI initiation.References:[1]Smolen JS, et al. Ann Rheum Dis. 2017;76:960–977[2]Strand V, et al.. Rheumatol Ther. 2017;4(2):489-502.[3]Acthar Gel (repository corticotropin injection; perscribing information). Mallinckrodt ARD LLC, Bedminster, NJ 07921 USA. 2019.Disclosure of Interests:Kyle Hayes Employee of: Mallinckrodt ARD, LLC, Mary Panaccio Employee of: Mallinckrodt Pharmaceuticals, Huanxue Zhou Consultant of: I am full time employee in KMK Consulting Inc. and providing consulting service to Mallinckrodt, Mohammed Fahim Consultant of: I am full time employee in KMK Consulting Inc. and providing consulting service to Mallinckrodt
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Cohen, Alexander T., Allison Keshishian, Theodore Lee, Gail Wygant, Lisa Rosenblatt, Patrick Hlavacek, Jack Mardekian, Daniel Wiederkehr, Janvi Sah, and Xuemei Luo. "Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases." Blood 134, Supplement_1 (November 13, 2019): 326. http://dx.doi.org/10.1182/blood-2019-121769.
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BACKGROUND: Venous thromboembolism (VTE) is the second leading cause of death in cancer patients. The treatment of cancer-associated VTE carries a significantly greater risk of major bleeding (MB) and recurrent VTE compared to that in non-cancer patients. CHEST Guidelines suggest the use of low molecular weight heparin (LMWH) over a vitamin K antagonist (VKA) in patients diagnosed with VTE and cancer. The last decade has seen an emergence of non-VKA anticoagulants (NOACs) for the treatment of VTE. Despite completed and ongoing clinical trials, there is a lack of real-world evidence comparing the effectiveness and safety of LWMH with VKAs and NOACs among VTE patients with active cancer. Therefore, this study evaluates the risk of MB, clinically relevant non-MB (CRNMB), and recurrent VTE (fatal or non-fatal) among VTE patients with active cancer prescribed apixaban, LMWH, or warfarin in routine clinical practice. METHODS: Four US commercial insurance claims databases were used to identify VTE patients with active cancer (defined as cancer diagnosis or cancer treatment [chemotherapy, radiation and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30-days following the first VTE event (01SEP2014-31MAR2018). Patients who used LMWH as bridging therapy for warfarin (≤14 days before or after warfarin initiation) were classified as warfarin users. Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Additional analysis using all available follow-up was also conducted. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of MB, CRNMB, and recurrent VTE. RESULTS: After applying all eligibility criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. The mean follow-up was 105, 88, and 113 days for apixaban, LMWH, and warfarin, respectively. Among the weighted VTE cancer population, 51% of the patients had metastatic cancer and 77% of patients received cancer treatment. Further, 15% of patients had very high-risk cancer (brain, stomach, or pancreas), and 40% patients had high-risk cancer (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma). Apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients also had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH (Figure). When the entire available follow-up period (mean follow-up was 137, 106, and 166 days for apixaban, LMWH, and warfarin, respectively) was used, the trends were similar to the 6-month analysis for apixaban vs. LMWH and warfarin vs. LMWH. However, apixaban patients were associated with a lower risk of both MB and recurrent VTE compared to warfarin patients. CONCLUSION: VTE patients with active cancer initiating apixaban had significantly lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH patients. Apixaban patients also had a lower risk of recurrent VTE compared to warfarin patients. These results may be helpful for clinicians in evaluating different anticoagulation treatments for VTE patients with active cancer. Further studies are needed to evaluate these outcomes between different anticoagulation treatment options. Figure Disclosures Cohen: Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; ACI Clinical: Consultancy; Navigant: Consultancy; McKinsey: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boston Scientific: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.
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Cohen, Alexander T., Allison Keshishian, Theodore Lee, Gail Wygant, Lisa Rosenblatt, Patrick Hlavacek, Jack Mardekian, Daniel Wiederkehr, Janvi Sah, and Xuemei Luo. "Safety and Effectiveness of Apixaban, LMWH and Warfarin Among Venous Thromboembolism (VTE) Patients with Active Cancer: A Subgroup Analysis of VTE Risk Scale." Blood 134, Supplement_1 (November 13, 2019): 327. http://dx.doi.org/10.1182/blood-2019-126931.
Full textAbstract:
BACKGROUND: Cancer is an independent risk factor for venous thromboembolism (VTE) and the strongest predictor for all-cause and pulmonary embolism-related mortality. VTE risk is 4-7 times higher in cancer patients compared to non-cancer patients. Different cancer types are associated with different risk of VTE. Cancers of the brain, pancreas, stomach, liver, lungs, and kidneys-and hematologic malignancies-have the strongest association with the occurrence of VTE. The Khorana risk score based on the cancer type, blood counts, and body mass index is one of the VTE risk scales to predict the risk of thrombosis in cancer patients. This study evaluates the risk of major bleeding (MB), clinically relevant non-major (CRNM) bleeding, and recurrent VTE (non-fatal and fatal) among VTE patients with active cancer prescribed apixaban, low-molecular weight heparin (LMWH), or warfarin stratified by VTE risk. METHODS: A pooled study using four US commercial insurance claims databases identified VTE patients diagnosed with active cancer (defined as cancer diagnosis [any stage] or cancer treatment [chemotherapy, radiation, and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30 days following the first VTE event (01SEP2014-31MAR2018). Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. A subgroup analysis using a modified Khorana VTE risk scale (cancer type only) was conducted. Patients were classified as very high risk (stomach, brain, or pancreas), high risk (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma), or other (all remaining cancer types) depending on their cancer type. Cox proportional hazard models were used to evaluate the risk of MB, CRNM bleeding, and recurrent VTE. The statistical significance (P<0.10) of the interaction between treatment and different levels of VTE risk was evaluated. RESULTS: After applying the selection criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. Among all VTE cancer patients after IPTW, 15% of patients had very high-risk cancer and 40% patients had high-risk cancer. In the main analysis, apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin (Figure). When stratifying by the VTE risk scale, study findings were generally consistent with the primary analysis and across the different subgroups. No significant interactions were observed for MB or CRNM bleeding (Figure). Two significant interactions were evident for recurrent VTE: apixaban trended towards a lower risk of recurrent VTE compared to LMWH across all three subgroups, but the magnitude of the difference was larger in the other cancer group vs. very high risk and high risk cancer groups. For warfarin vs. LMWH, different trends in recurrent VTE risk were observed among patients with different VTE risk levels (Figure). CONCLUSION: Across subgroups of VTE cancer patients with different VTE risk levels, apixaban had a lower risk of recurrent VTE compared to warfarin and a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH consistent with the overall results. Warfarin patients had a similar risk of MB and CRNM bleeding compared to LMWH. Further studies are needed to evaluate the role of anticoagulants in high-risk subgroups of VTE cancer patients. Figure Disclosures Cohen: Aspen: Consultancy, Speakers Bureau; CSL Behring: Consultancy; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Guidepoint Global: Consultancy; TRN: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; Boston Scientific: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Speakers Bureau; AbbVie: Consultancy; GLG: Consultancy; Medscape: Consultancy, Speakers Bureau; McKinsey: Consultancy; Navigant: Consultancy; Takeda: Consultancy; ACI Clinical: Consultancy. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.
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Schreiber, K., C. Johansen, U. F. Jensen, A. Egeberg, S. F. Thomsen, A. L. Hansen, T. B. Laurberg, L. Skov, and L. E. Kristensen. "PARE0024 AWARENESS ABOUT FAMILY PLANNING AND PREGNANCY EXPECTATION AMONG PATIENTS WITH CHRONIC INFLAMMATORY DISEASE OF THE SKIN OR JOINTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1297.1–1298. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3723.
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Background:Patients affected by chronic inflammatory diseases of the skin or joints (CIDs; including psoriasis [PSO], rheumatoid arthritis [RA], juvenile idiopathic arthritis [JIA], psoriatic arthritis [PsA], non-radiographic axial spondyloarthritis [nr-axSpA; reported in the survey as ‘axSpA’], or ankylosing spondylitis [AS]) may be challenged in their attempts to have children. A multinational survey conducted in Europe and the US, including 969 patients, revealed that most patients’ concerns regarding family planning and pregnancy (FPP) were inadequately or inconsistently addressed.1Objectives:To investigate the general level of information on FPP and the potential concerns among Danish patients with CIDs.Methods:An online survey to identify FPP issues was designed, and CID patients aged 18–50 years (yrs) were included. Respondents were recruited through patient organisations providing their members with a link to the questionnaire. In addition to demographics, information relating to time of diagnosis, treatments received, pregnancies, and course of disease were collected along with access to and concerns regarding FPP. Descriptive statistics were applied.Results:Eligible patients included 368 with rheumatological diagnoses (RA, PsA, JIA, nr-axSpA, or AS; 304 [83%] female, mean age: 40 yrs; 64 [17%] male, mean age: 42 yrs) and 95 with dermatological diagnoses (PSO or PsA; 64 [67%] female, mean age: 37 yrs; 31 [33%] male, mean age: 42 yrs). Among the rheumatic patients, 43% of females and 53% of males were currently receiving systemic treatment and 37% of females and 22% of males had received >3 different systemic treatments (other than painkillers and non-steroidal anti-inflammatory drugs [NSAIDs]). Lack of access to FPP information was consistent across age groups, but higher in those with dermatological diagnoses (Table).In total, 68% of patients with rheumatological and 73% with dermatological diagnoses had biological children and among these 18% and 23% of patients, respectively, indicated their disease had affected how many children they had or planned to have. The most frequent concerns among patients with rheumatological diagnoses were the potential physical impact of a pregnancy, disease worsening, heredity and being able to take care of the child (19, 16, 16 and 13%, respectively), whilst disease worsening and heredity (12 and 16%, respectively) were the most frequent concerns in those with dermatological diagnoses. Many patients experienced disease worsening during or after pregnancy (rheumatologic diagnoses: 16% and 34%; dermatologic: 20% and 59%, respectively).Conclusion:Danish CID patients of reproductive age have concerns related both to their disease and to FPP, which affect their decisions around family planning. The majority of patients responding to this survey reported limited access to information about FPP, pointing to a need for healthcare professionals to provide standardised family planning information.References:[1] Chakravarty E. BMJ Open 2014;4:e004081.Table.Thematic analysis and quotesThemeDescriptionQuoteOral-RA linksRA medications caused dry mouthThe medications, really, really are awful on your mouth, in particular prednisone. I get very raw gums… it [was] painful to brush my teeth.We don’t have saliva to wash things away. We have a different mouth floraComplicated oral careTime-demanding oral care routines.Multiple oral health care tools and adaptations used depending on current oral health, and RA activity.The severe pain made it very hard to open my mouth to brush my teeth. The joint damage [makes it] really hard to handle a toothbrush.We have to have toothbrushes with a wide handle… and different attachments when we need them.Even with those [special] products, the pain sometimes was just overwhelming. I’m dedicated about brushing my teeth, but boy, it was a struggle. It took me a long time to brush my teeth.Access to professional oral careLack of dental insurance and costs of careLogistical access: multiple dental visits.Physical access: attending appointments; prolonged sitting in a dental chair.I have a hygienist, and a dentist, and a gum dentist and a bunch of dentists with fancy names. I see them every 3 months.Dental offices have dental hygienists. And some of them are an A+, and some of them are C-…it’s important that hygienists are trained, that they really understand the tools.When I go back in the [dental] chair, it was uncomfortable [when first diagnosed]. I struggled. I couldn’t keep my mouth open.Shame due to oral healthShame relating to poor oral health.Seeking oral care possibly considered unusual for their age.I would feel ashamed. Something’s wrong. Everyone around me has these beautiful teeth. I don’t, and something is wrong.I’m getting braces. At my age, I’m getting braces.Table.Proportion of patients with rheumatological or dermatological diagnoses who reported having little or no access to FPP information, stratified by ageAgeRheumatological diagnosisN (%)Dermatological diagnosisN (%)18–29 yrs19 (49)14 (74)30–39 yrs61 (58)16 (73)40–50 yrs134 (60)34 (63)Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Karen Schreiber Consultant of: UCB Pharma (Advisory Board), Caecilie Johansen Consultant of: UCB Pharma (Advisory Board), Ulla-Fie Jensen Consultant of: UCB Pharma (Advisory Board), Employee of: UCB Pharma, Alexander Egeberg Grant/research support from: Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation and the Kgl Hofbundtmager Aage Bang Foundation, Consultant of: UCB Pharma (Advisory Board), Speakers bureau: AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co. Ltd., Pfizer, Eli Lilly, Novartis, Galderma, Dermavant, UCB Pharma, Mylan, Bristol-Myers Squibb and Janssen Pharmaceuticals, Simon F. Thomsen Grant/research support from: UCB Pharma, AbbVie, Novartis, Sanofi, Leo Pharma, and Janssen Pharmaceuticals, Consultant of: UCB Pharma (Advisory Board), AbbVie, Novartis, Sanofi, Eli Lilly, Roche, Janssen Pharmaceuticals, Pfizer, Celgene, Leo Pharma, Almirall, Speakers bureau: UCB Pharma, AbbVie, Novartis, Sanofi, Eli Lilly and Leo Pharma, Asbjorn L Hansen Consultant of: UCB Pharma (Advisory Board), Employee of: UCB Pharma, Trine Bay Laurberg Consultant of: UCB Pharma (Advisory Board), Lone Skov Grant/research support from: Pfizer, AbbVie, Novartis, Sanofi, Janssen Pharmaceuticals, and LEO Pharma, Consultant of: UCB Pharma (Advisory Board), AbbVie, Janssen Pharmaceuticals, Novartis, Eli Lilly, LEO Pharma, Almirall, and Sanofi, Speakers bureau: AbbVie, Eli Lilly, Novartis, and LEO Pharma. Investigator for AbbVie, Janssen Pharmaceuticals, Boehringer Ingelheim, AstraZeneca, Eli Lilly, Novartis, Regeneron, and LEO Pharma, Lars Erik Kristensen Consultant of: UCB Pharma (Advisory Board), Sannofi (Advisory Board), Abbvie (Advisory Board), Biogen (Advisory Board), Speakers bureau: AbbVie, Amgen, Biogen, Bristol-Myers Squibb,Celgene, Eli Lilly, Gilead, Forward Pharma, Janssen Pharmaceuticals, MSD, Novartis, Pfizer, and UCB Pharma
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Gowda, Sachit, Amelia Langston, Jonathan L. Kaufman, Nishi N. Shah, Mary Jo Lechowicz, Lawrence H. Boise, Sagar Lonial, and Ajay K. Nooka. "Hospitalization Outcome Metrics Based On Payer Status In Myeloma Patients That Receive Autologous Stem Cell Transplant (ASCT)." Blood 122, no. 21 (November 15, 2013): 5606. http://dx.doi.org/10.1182/blood.v122.21.5606.5606.
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Abstract Background Myeloma patients have experienced great survival benefits in the last decade due to the use of novel agents and autologous stem cell transplant (ASCT). Prior studies report a complex interplay between payer status and the receipt of ASCT. We have evaluated if the payer status affects outcome metrics of length of stay (LOS), in-hospital mortality rate (IHM), and total hospitalization charges in the context of survival benefit of myeloma with this procedure. Methods We used the NIS (Nationwide Inpatient Sample) 2001-2010 database (part of the HCUP database) to obtain the patient data. Using private insurance as the reference group, we performed multivariate logistic regression to understand the association of payer status with LOS, IHM, hospitalization charges. We adjusted our model for age, race and the presence or absence of co-morbidities. Comorbidites were identified using comorbidity software that created measures reported by Elixhauser et al. Results From 01/2001 until 12/2010, 25656 admissions for ASCT as principal procedure for the principal diagnosis of multiple myeloma were included in our analysis. The IHM rate during this period based on payer status was 3.04%, 1.56%, 1.20% and 0.4% for medicare, medicaid, private insurance and others, respectively. Median LOS for medicaid and medicare were 17 days while private insurance and other insurances had a median LOS of 16 days. Medicare patients undergoing ASCT had higher likelihood of IHM compared to private insurance [Odds ratio: 2.62 ( 95%CI 1.46 – 4.72)]; while medicaid patients had non-significant increase. LOS in medicaid patients was longer compared to private insurance [(Odds ratio: 1.53 ( 95%CI 1.16-2.02)]. Conclusion Myeloma patients with medicare undergoing ASCT had higher likelihood of in-hospital death compared to patients with private insurance. Medicaid patients had a lengthier in-hospital stay but there seems to be no significant difference in hospitalization charges in the different payer groups. However, the acceptable overall cumulative mortality rate suggests that myeloma patients can continue to enjoy the survival benefits associated with ASCT despite payer status. Further studies evaluating long-term outcomes outside the hospital admission would be required to better understand the association of payer status with overall survival benefits of ASCT. Disclosures: Kaufman: Onyx: Consultancy; Celgene: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Janssen: Consultancy; Millenium: Consultancy; Merck: Research Funding. Boise:Onyx: Consultancy. Lonial:Millennium: Consultancy; Celgene: Consultancy; Novartis: Consultancy; BMS: Consultancy; Sanofi: Consultancy; Onyx: Consultancy.
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Gouverneur, A., J. Avouac, C. Prati, J. L. Cracowski, T. Schaeverbeke, A. Pariente, and M. E. Truchetet. "POS0225 RISK OF MAJOR CARDIOVASCULAR EVENT ACROSS JAK INHIBITOR TREATED PATIENTS: ANALYSIS OF A NATIONAL CLAIM DATABASE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 331.2–332. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2976.
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Background:Inhibiting a specific JAK may impede more than one pathway, explaining both the efficacy and adverse effects observed with JAK inhibitors (JAKi). Among those, there have been recent concerns about potential thromboembolic risks with these drugs. As patients enrolled are not representative of all patients who may receive JAKi, data from trials are unlikely to provide definitive answers. Real impact of JAKi in real life on major cardiovascular events is not known.Objectives:To evaluate the risk of venous and arterial thromboembolic events with the use of JAKi in a real-world setting.Methods:A self-controlled case series analysis (method in which individuals act as their own control) was performed using data from the French national healthcare insurance system SNDS (“Système National des Données de Santé”), which included all anonymized individual level data about sociodemographic data, outpatient healthcare dispensed, hospital discharge summaries, and registration status for a list of 30 long term diseases. All patients treated by JAKi (baricitinib or tofacitinib) for rheumatoid arthritis, psoriasis arthritis and/or inflammatory bowel disease, and with at least one thromboembolic event (venous (VTE): deep vein thrombosis (DVT), pulmonary embolism (PE), arterial (ATE): acute coronary syndrome (ACS), myocardial infarction (MI), transient ischemic attack (TIA) and stroke) between 2017/11/01 and 2019/06/30 were included in the study. Associations were evaluated by incidence rate ratios (IRR), which compare the rate of events during exposed periods with rate of event during all other observed time periods. Exposed periods were defined as i) exposure to JAKi, ii) the month following exposure (post-exposure 1-30 days), and iii) long-term post-exposure (31 to 60 days). A pre-exposure period of 7 days was individualized to identify event-dependent probabilities of exposure and potential reverse causality bias, and all other periods were considered as non-exposed periods.Results:Among the 5,870 patients treated with JAKi between 2017/11/01 and 2019/06/30, 94 presented an incident thromboembolic event and were included. Almost two thirds were female (n=61, 64.9%), and median age was 65.4 [IQR: 55.5; 75.8] years. Most of patients have a rheumatoid arthritis (n=91, 96.8%), 62 (66.0%) were treated by baricitinib, and 32 (34.0%) by tofacitinib. Almost half (n=42, 44.7%) presented a venous thromboembolism, mainly DVT (n=31, 33.0%), and 52 (55.3%) presented an arterial thromboembolism, mainly MI (n=16, 17.0%) and stroke (n=14, 14.9%). Eleven patients (11.7%) died during the study period. The median time of occurrence of VTE was 4.3 [IQR: 2.5; 8.9] months, and 6.1 [IQR: 3.3; 9.2] months for ATE.The median duration of exposure was 6.0 [IQR: 3.3; 10.1] months for VTE, and 12.0 [IQR: 4.8; 15.3] months for ATE. The IRR for VTE and ATE were increased during exposure, and during the 30 days following exposure (Table 1). The IRR for VTE was only increased during exposure and in the early post-exposure phase contrary to the IRR for ATE that was also increased in the pre-exposure 7-Day period. Analysis conducted on survival patients confirmed results.Table 1.NPatient-yearsIRR95%CIVenous thromboembolic eventsNon-exposure (reference)83975.01-Pre-exposure to JAK-i1135.24.70.6-38.0Exposure to JAK-i272090.59.84.1-23.3Post-exposure 1-30 d5369.06.21.9-19.9Post-exposure 31-60 d1139.01.50.2-12.6Arterial thromboembolic eventsNon-exposure (reference)74076.81-Pre-exposure to JAK-i3344.111.52.8-46.8Exposure to JAK-i326363.87.42.9-18.7Post-exposure 1-30 d8659.211.53.8-34.6Post-exposure 31-60 d2132.24.30.8-22.0Conclusion:The present study found an increased risk of VTE and ATE for baricitinib and tofacitinib. The risk persists in the month following the discontinuation of treatment but disappears after day 30 post-exposure.Disclosure of Interests:Amandine Gouverneur: None declared, Jérôme Avouac Consultant of: JA has/had consultancy relationship and/or has received research funding in the area of potential treatments for rheumatoid arthritis from (last three years): Abbvie, Galapagos, Pfizer, Bristol Myers Squibb, Sanofi, Nordic Pharma, Chugai and MSD., Grant/research support from: JA has/had consultancy relationship and/or has received research funding in the area of potential treatments for rheumatoid arthritis from (last three years): Abbvie, Galapagos, Pfizer, Bristol Myers Squibb, Sanofi, Nordic Pharma, Chugai and MSD., Clément Prati: None declared, Jean-Luc Cracowski: None declared, Thierry Schaeverbeke Consultant of: TS consultancy and/or research fundings: Abbvie, Lilly, Pfizer, Galapagos, Novartis, BMS, Medac, NordicPharma, Biogen, Mylan, Janssen., Grant/research support from: TS consultancy and/or research fundings: Abbvie, Lilly, Pfizer, Galapagos, Novartis, BMS, Medac, NordicPharma, Biogen, Mylan, Janssen., Antoine Pariente Grant/research support from: AP reports acting as an independant expert towards the French Medicines Agency (Agence Nationale de Securité du Médicament et des Produits de Santé, ANSM) and the European Medicines Agency (EMA). AP coordinates the DRUGS Systematised Assessment in real-liFe EnviRonment (DRUGS-SAFER) programme funded by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)., Marie-Elise Truchetet Consultant of: has/had consultancy relationship and/or has received research funding in the area of potential treatments for rheumatoid arthritis and spondyloarthritis and their complications from (last three years): Abbvie, Galapagos, Lilly, Medac, Novartis, Pfizer, and Roche., Grant/research support from: has/had consultancy relationship and/or has received research funding in the area of potential treatments for rheumatoid arthritis and spondyloarthritis and their complications from (last three years): Abbvie, Galapagos, Lilly, Medac, Novartis, Pfizer, and Roche.
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Ogunshakin, Nelson. "Briefing: Consultants face indemnity insurance crisis." Proceedings of the Institution of Civil Engineers - Civil Engineering 157, no. 4 (November 2004): 149. http://dx.doi.org/10.1680/cien.2004.157.4.149.
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Stewart, Ronald B. "The Future of Pharmacy: Armageddon or Pollyanna?" Annals of Pharmacotherapy 29, no. 12 (December 1995): 1292–96. http://dx.doi.org/10.1177/106002809502901219.
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Objective: To review important events and predictions about pharmacy that have occurred in the practice since my career began and describe changes in opportunities that have developed over the past 35 years. Data Sources: I used personal recollections and information from the State of Florida Pharmacy Association journal over a 35-year period. Other supporting data were used to describe current practice opportunities. Data Synthesis: Over the past 35 years many people have predicted the demise of the pharmacy profession. The reasons stated for this demise have varied over the years and include government interference, the expansion of chain and mail-order pharmacies, managed care, loss of the compounding function, Medicaid reimbursement, national health insurance, and pharmacy technicians. Despite these gloomy predictions, community and hospital pharmacies have flourished over the past 35 years and new roles for pharmacists have emerged in managed care, consultant pharmacy, academic pharmacy, and the pharmaceutical industry. with the enactment of the Omnibus Budget Reconciliation Act of 1990 requirements, it appears that the public has even greater expectations from community pharmacists as medication advisors. The pharmacy profession is changing more rapidly than ever and pharmacists must prepare for these rapid changes. Colleges of pharmacy should inculcate in their students the importance of lifelong learning to keep abreast with change. Conclusions: Society will always need experts on drugs. Pharmacists must rise to the challenge and accept new and changing roles in drug therapy management. If that occurs the future of pharmacy will be ensured.
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Pina Vegas, L., P. Le Corvoisier, L. Penso, M. Paul, E. Sbidian, and P. Claudepierre. "POS0201 RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS INITIATING BIOLOGICS/APREMILAST FOR PSORIATIC ARTHRITIS: A NATIONWIDE POPULATION-BASED STUDY USING THE FRENCH HEALTH INSURANCE DATABASE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 317.2–317. http://dx.doi.org/10.1136/annrheumdis-2021-eular.287.
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Background:Psoriatic arthritis (PsA) is associated with other diseases of the spectrum of spondyloarthritis but also appears to be linked to an increased prevalence of numerous comorbidities and more specifically cardiovascular risk factors and events. Several biological disease-modifying anti-rheumatic drugs (bDMARDs) have demonstrated anti-inflammatory effects in PsA. However, their comparative cardiovascular safety profiles remain unknown.Objectives:Our objective was to assess the relative comparative risk of major adverse cardiovascular events (MACEs) of different classes of bDMARDs or apremilast for PsA.Methods:This nationwide cohort study involved the administrative healthcare database of the French health insurance scheme covering approximately 67 million individuals linked to the hospital discharge database. All adults with PsA who were new users of bDMARDs/apremilast (neither in the year before the index date) during 2015-2019 were included. Patients with previous cardiovascular diseases were excluded. End of follow-up was December 31, 2019. The primary end point was an occurrence of MACE (acute myocardial infarction and ischaemic stroke) in a time-to-event analysis with propensity score-weighted Cox and Fine-Gray models (including age, sex, inflammatory diseases associated, cardiovascular risk biomarkers and other comorbidities). To assess the sensitivity of the estimated weighted hazard ratio (HRw) with respect to several possible models, we performed a per-protocol analysis, a conventional multivariate Cox model, an analysis using a larger definition of MACE, an analysis modifying the new-user definition (as those who had not filled a prescription for a bDMARDs or apremilast for 5 years before the index date) and an analysis modifying the treatment discontinuation definition.Results:Between 2015 and 2019, we included 9,510 bDMARD new users (mean age 48.5±12.7 years; 42% men), including 7,289 starting a TNF inhibitor, 1,058 an IL12/23 inhibitor and 1,163 an IL17 inhibitor, with 1,885 apremilast new users (mean age 54.0±12.5 years; 44% men). MACEs occurred in 51 (0.4%) patients (Figure 1). After propensity score weighting, the risk of MACEs was significantly greater with IL12/23 (HRw 2.0, 95%CI 1.3-3.0) and IL17 (HRw 1.9, 95%CI 1.2-3.0) inhibitors than TNF inhibitors, with no significant increased risk with apremilast (HRw 1.3, 95%CI 0.8-2.2). Similar results were observed with the Fine-Gray competing-risks survival model. The sensitivity analyses results were consistent with those of the main analysis.Conclusion:Analysis of a large national database revealed an overall small number of MACEs. Using robust methodology from the causal inference field, the risk of MACEs was greater for PsA new users of IL12/23 and IL17 versus TNF inhibitors. The risk of MACEs did not significantly differ between new users of apremilast and new users of TNF inhibitors.Figure 1.Flowchart for analytic approach Data are n. bDMARD: biological disease-modifying antirheumatic drugs; CVD: cardiovascular disease; TNF: tumor necrosis factor; IL: interleukin; MACE: major adverse cardiac events.Acknowledgements:L Pina Vegas received a Master 2 grant from the French Society of Rheumatology (Bourse Master 2ème Année 2019)Disclosure of Interests:Laura Pina Vegas: None declared, Philippe Le Corvoisier: None declared, Laetitia Penso: None declared, Muriel Paul: None declared, Emilie Sbidian: None declared, Pascal Claudepierre Speakers bureau: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Consultant of: Abbvie, Pfizer, Roche-Chugai, Bristol-Myers Squibb, MSD, UCB, Novartis, Janssen, Lilly, Celgene (consulting fees, less than 10,000 $ each)., Employee of: Roche Chugai, Sanofi Aventis, Celgene, Pfizer, MSD, Novartis and BMS (investigator).
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Hwang, M., M. Weisman, L. S. Gensler, A. Tahanan, M. Ishimori, T. Hunter, R. Bolce, et al. "POS0904 FACTORS ASSOCIATED WITH SWITCHING FROM ONE ANTI-TNF AGENT TO ANOTHER ANTI-TNF, OR IL17 AGENT IN PATIENT WITH ANKYLOSING SPONDYLITIS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 710.1–710. http://dx.doi.org/10.1136/annrheumdis-2021-eular.515.
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Background:A recent study examining Commercial Claims Insurance database found that many patients with ankylosing spondylitis (AS) do not remain on their initial TNF inhibitor two years after initiation, particularly women and those taking opioids.Objectives:To examine factors associated with switching from one TNF inhibitor (i)agent to either another TNFi, IL-17i or JAKi over time (at <2years and >2 years) in a longitudinal cohort of AS patients.Methods:Patients enrolled in the Prospective Study of Outcomes in AS (PSOAS), an observational longitudinal study of predictors of AS severity operative since 2002-2020 including over 1250 patients meeting modified New York criteria. Data collected included age, gender, ethnicity, HLA-B27 status, disease activity (BASDAI or ASDAS), erythocyte sedimentation rate (ESR), C-reactive protein (CRP), disease severity,(functional (BASFI) or radiographic (mSASSS)), comorbidities, smoking, exercise, disease duration, depression (either by self report or by the Center for Epidemiologic Studies Depression Scale (CES-D) and other medication usage (NSAIDs, including the NSAID index, nonbiologic DMARDs, opioids, anti-depressants, anxiolytics and hypnotics). Logistic regression models were built to identify clinical and sociodemographic characterstics associated with medication switching to another TNFi, IL-17i, or other biologic therapy (another TNFi, Il-17i, or JAKi) within 2 years and after 2 years of initiation).Results:Of those patients in PSOAS who had at least two years of follow-up, 496 were prescribed anti-TNF, 34 anti-IL-17 and 3 anti-JAK agents. According to the multinomial logistic regression analysis, patients who switched from their original TNFito another TNFi, IL-17i or JAKi within two years after initiating their original TNFi were more likely to be older, have higher baseline subjective disease activity (BASDAI), less radiographic severity by MSASSS, exercise > 120 minutes/week and less likely to be currently smoking. Patients who switched after two years were less likely be depressed, had shorter disease duration, had greater subjective disease activity, were more likely to be exercising > 120 minutes/week, and had more comorbidities.Conclusion:Different factors were encountered in AS patients who switched from their initial TNFi to another TNFi, IL-17i or JAKi within 2 years versus after 2 years of treatment.Table 1.Factors Associated With Switching From One TNFi To A Second TNFi or IL-17i or JAKi Before or After Two Years Based On Multinomial Logistic Regression Model (N=496 Patients)VariableSwitched within 2 years vs. not switchedp-value*Switched after 2 years vs. not switchedp-value*Gender (Male vs. Female)0.99(0.637, 1.549)0.980.95 (0.528, 1.719)0.87HLA-B27_(+ vs. -)0.99 (0.639, 1.523)0.950.66 (0.365, 1.192)0.17Depression (CESD≥ 16 or self-report)(Yes vs. No)0.99 (0.676, 1.445)0.950.35 (0.182, 0.672)0.002Disease duration at baseline (≥20 vs. <20 years)0.72 (0.485, 1.062)0.100.27 (0.146, 0.491)<0.001Age at baseline (≥40 vs. <40) (years)2.00 (1.291, 3.101)0.0021.23 (0.693, 2.193)0.48CRP (≥0.8 vs. <0.8)1.94 (1.230, 3.056)0.0040.90 (0.454, 1.789)0.77BASFI (≥40 vs. <40)1.34 0.852, 2.118)0.200.87 (0.450, 1.688)0.68BASDAI (≥4 vs. <4)1.73 (1.064, 2.797)0.032.31 (1.202, 4.427)0.01NSAID index (≥50 vs. <50)1.32 (0.822, 2.128)0.250.83 (0.437, 1.586)0.58NSAIDs used (Yes vs. No)0.84 (0.534, 1.309)0.430.85 (0.479, 1.510)0.58Exercise (≥120 vs. <120) (minutes/week)1.95 (1.396, 2.731)<0.0011.66(1.057, 2.613)0.03ASDAS (≥3 vs. <3)0.78 (0.454, 1.356)0.391.07 (0.478, 2.399)0.87Number of comorbidities (≥2 vs. <2)1.40 (0.997, 1.951)0.051.63 (1.029, 2.575)0.04mSASSS (≥4, vs. <4)0.63 (0.421, 0.957)0.030.81(0.474, 1.392)0.03Current smoker (Yes vs No)0.69 (0.385, 1.225)<0.0010.79 (0.297, 2.076)0.20*p-values calculated based on multinomial logistic regression model when switching is defined as being prescribed a second TNFi or taking IL-17i or JAKi before or after 2 years from first TNFi initiationDisclosure of Interests:Mark Hwang Consultant of: UCB, Novartis, Michael Weisman Consultant of: Novartis, GSK, UCB, Lilly, Lianne S. Gensler Consultant of: AbbVie, GlaxoSmithKline, Eli Lilly, Novartis, Pfizer, UCB Pharma, Amirali Tahanan: None declared, Mariko Ishimori: None declared, Theresa Hunter Employee of: Eli Lilly, Rebecca Bolce Employee of: Eli Lilly, Jeffrey Lisse Employee of: Eli Lilly, Mohammad Rahbar: None declared, Minyang Shan Employee of: Eli Lilly, John D Reveille Consultant of: UCB, Grant/research support from: Eli Lilly
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Hamad, Yasir, Katelin B. Nickel, Yvonne Burnett, and Margaret A. Olsen. "610. Incidence of Acute Kidney Injury in Outpatient Parenteral Antimicrobial Therapy (OPAT) Patients Receiving Vancomycin." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S366. http://dx.doi.org/10.1093/ofid/ofaa439.804.
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Abstract Background Vancomycin therapy is known to be associated with nephrotoxicity. Predictors of nephrotoxicity in outpatients are not well defined and have only been reported in relatively small studies. We examined the factors associated with incidence of nephrotoxicity during outpatient parenteral antimicrobial therapy (OPAT) using administrative data. Methods A large insurance claims database of privately insured patients (IBM-MarketScan) ages 18 - 64 from 2010 to 2016 was queried for patients discharged from the hospital on vancomycin OPAT. The primary endpoint was 42-day hospital readmission with acute kidney injury (AKI). A Chi-square test was used to examine associations with AKI. Factors with significant associations in univariate analysis were then incorporated into a multivariable logistic regression model. Results A total of 14,196 patients were included in the study, median age was 54 years and 53.8% were male. Hospital readmission with AKI occurred in 385 (2.7 %). Factors associated with AKI in univariate analysis included older age, living in a rural area, heart failure (CHF), chronic kidney disease (CKD), liver disease, diabetes, cancer, septicemia, MRSA infection, concomitant penicillin therapy, receiving therapy at home versus an infusion center, and infectious diseases consult during index hospitalization. In the multivariable model, septicemia, CHF, CKD, liver disease, and concomitant use of a penicillin family drug were independently associated with increased risk of acute kidney injury (Table). Conclusion Septicemia, use of penicillins and some comorbidities were associated with AKI in patients treated with vancomycin OPAT. Patients at high risk for vancomycin nephrotoxicity should be monitored closely and an alternative therapy should be considered. Table Disclosures Margaret A. Olsen, PhD, MPH, Merck (Grant/Research Support)Pfizer (Consultant, Grant/Research Support)
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Whicher, Bryan. "Professional Indemnity Insurance for Scientific and Safety Consultants." Safety and Reliability 23, no. 4 (December 2003): 55–56. http://dx.doi.org/10.1080/09617353.2003.11690774.
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Pappas, D. A., T. Blachley, J. H. Best, S. Zlotnick, K. Emeanuru, and J. M. Kremer. "FRI0104 PERSISTENCE OF TOCILIZUMAB THERAPY AMONG PATIENTS WITH RHEUMATOID ARTHRITIS: DATA FROM THE US-BASED CORRONA RHEUMATOID ARTHRITIS REGISTRY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 631–32. http://dx.doi.org/10.1136/annrheumdis-2020-eular.708.
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Background:Understanding the persistence of biologic therapies and factors associated with discontinuation can help inform treatment decisions for patients with rheumatoid arthritis (RA).Objectives:To evaluate the persistence of tocilizumab (TCZ) therapy and identify factors associated with its discontinuation among US patients with RA in routine clinical practice.Methods:Eligible participants were TCZ-naïve patients enrolled in the Corrona RA registry who initiated TCZ after January 1, 2010 and had ≥ 1 follow-up visit. Persistence of therapy was defined as maintaining continuous TCZ treatment with no interruptions; patients were considered no longer persistent upon the first discontinuation of TCZ. Persistence was calculated using Kaplan-Meier survival analysis for the overall population; secondary analyses evaluated persistence excluding patients who stopped TCZ with no reported reason for discontinuation (patients with non-medical reasons for discontinuation [eg, insurance] were censored) and in only those patients who initiated intravenous (IV) TCZ. Cox proportional hazards modeling was used to identify factors associated with persistence.Results:A total of 1789 TCZ initiators were included; 81.0% were female, 85.0% were white and 75.4% were overweight or obese. The mean (SD) age was 58.5 (12.6) years and mean (SD) disease duration was 12.0 (9.6) years. Most patients (93.4%) had prior biologic use and 67.4% had received ≥ 2 prior biologics. Overall, 28.8% initiated TCZ as monotherapy. Among all TCZ initiators, the median (95% CI) duration of persistence was 20 (18 to 22) months (Fig 1). Factors associated with an increased hazard of TCZ discontinuation included smoking and higher baseline CDAI, whereas prior tumor necrosis factor inhibitor (TNFi) use was associated with a reduced hazard (Fig 2A). After excluding patients with no reported reason for discontinuation (remaining n = 1303), the median (95% CI) duration of persistence was 46 (38 to 55) months (Fig 1); smoking, use of 1 prior non-TNFi and higher baseline patient pain score were associated with an increased hazard of discontinuation (Fig 2B). Among the 1284 patients who initiated TCZ IV, median (95% CI) duration of persistence was 22 (19 to 25) months (Fig 1); smoking, lack of insurance and higher baseline patient fatigue score were associated with an increased hazard of discontinuation, whereas use of 1 prior TNFi was associated with a decreased hazard (Fig 2C).Conclusion:In this real-world population of US patients with RA, TCZ was most frequently initiated after an inadequate response to ≥ 2 biologics. Overall median duration of persistence was approximately 20 months and was higher (46 months) when patients with no reported reason for TCZ discontinuation were excluded. As expected, factors indicative of higher baseline disease activity were associated with shorter persistence.Acknowledgments:This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Genentech, Inc., with financial support provided by Genentech, Inc.Disclosure of Interests:Dimitrios A Pappas: None declared, Taylor Blachley Employee of: Corrona, LLC, Jennie H. Best Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Steve Zlotnick Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Kelechi Emeanuru Employee of: Corrona, LLC – employment, Joel M Kremer Shareholder of: May own stocks and opinions, Grant/research support from: Research and consulting fees from AbbVie Inc., Consultant of: AbbVie, Amgen, BMS, Genentech, Inc., Gilead, GSK, Lilly, Pfizer, Regeneron and Sanofi, Employee of: Corrona, LLC employee
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Deodhar, A., K. Winthrop, R. Bohn, B. Chan, R. Suruki, J. Stark, H. Yun, S. Siegel, L. Chen, and J. Curtis. "SAT0370 TUMOUR NECROSIS FACTOR INHIBITOR THERAPY DOES NOT REDUCE THE INCIDENCE OF COMORBIDITIES AND EXTRA-ARTICULAR MANIFESTATIONS IN ANKYLOSING SPONDYLITIS: AN ANALYSIS OF THREE US CLAIMS DATABASES." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1132.1–1133. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4201.
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Background:Comorbidities and extra-articular manifestations (EAMs) substantially increase disease burden and mortality risk in patients (pts) with ankylosing spondylitis (AS).1,2Tumour necrosis factor inhibitors (TNFi) are highly efficacious and effective in AS treatment (tx), and are used after inadequate response to non-steroidal anti-inflammatory drugs.3,4However, the impact of TNFi on the incidence of comorbidities and EAMs in pts with AS is unknown.5Objectives:To determine the incidence of comorbidities and EAMs in TNFi vs non-TNFi treated pts with AS in the US.Methods:This was a retrospective, observational cohort study using data from 3 healthcare insurance claims databases: Multi-Payer Claims Database (MPCD Optum Insight; 2007–2010), Truven MarketScan®(2010–2014) and US Medicare Fee-for-Service Claims database (2006–2014). Eligible pts: ≥20 years (yrs) for MarketScan/MPCD or ≥65 yrs for Medicare, had an AS diagnosis (≥2 International Classification of Disease, 9thversion [ICD-9] diagnosis codes of 720.0 from a rheumatologist) and ≥12 months’ continuous medical and pharmacy enrolment prior to AS diagnosis (AS index date). Pts with AS not receiving tx were excluded. Tx exposure was reported from the first date of a new prescription/administration of an AS tx (no prior exposure) after the AS index date. Crude incidence rates (IR; shown as cases/100 pt-yrs) were calculated for EAMs (uveitis, psoriasis [PSO], psoriatic arthritis [PsA], inflammatory bowel disease [IBD]), with follow-up until the earliest of: death, lost medical/pharmacy coverage, study period end, first outcome occurrence, tx switch/discontinuation. Hazard ratios (HRs) of comorbidities (hospitalised infection, solid cancers) and EAMs for propensity score (PS)-matched pt groups were calculated using Cox proportional hazard regression models. Pts with the specific comorbidity/EAM of interest prior to AS index date were excluded. PS analyses assessed probability of TNFi initiation vs non-TNFi tx and adjusted for factors including comorbidities and demographics. HRs with confidence intervals crossing 1 are not reported.Results:20,460 pts with AS were eligible (MPCD: 2,384; MarketScan: 9,032; Medicare: 9,044). In all databases, crude IR of EAMs were higher for TNFi vs non-TNFi treated pts (Figure 1). In the PS-matched cohort, incidences of hospitalised infections were lower in TNFi vs non-TNFi treated pts from the MarketScan and Medicare databases (Figure 2). Higher incidences of solid cancers and EAMs were observed in TNFi vs non-TNFi treated pts; Medicare data (Figure 2). A higher risk of PsA and PSO was seen in TNFi vs non-TNFi treated pts; MarketScan data (Figure 2). PS-matched cohort data from the MPCD database were non-significant.Conclusion:Despite strong efficacy in treating AS-related signs and symptoms, similar incidence of comorbidities and increased incidence of some EAMs (IBD, PSO/PsA, uveitis) was seen in TNFi vs non-TNFi treated pts in the PS-matched analyses. This may be due to channelling of pts with more severe AS to receive TNFi, despite the PS-matched analysis aiming to overcome this. Moreover, prior medical history of Medicare pts may not be captured in the database, as pts are typically older with longer disease durations. While these results confirm previous findings,6a prospective observational study is required to generalise to pts outside the US.References:[1]Stolwijk C. Ann Rheum Dis 2015;74:1373–8;[2]Bremander A. Arthritis Care Res 2011;63:550–6;[3]Braun J. Scand J Rheumatol 2005;34:178–90;[4]Ji X. Front Pharmacol 2019;10:1476;[5]Maxwell LJ. Cochrane Database Syst Rev 2015:CD005468;[6]Walsh J. J Pharm Health Serv Res 2018;9:115–21.Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Kevin Winthrop Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer Inc, Roche, UCB, Rhonda Bohn Consultant of: UCB Pharma, Benjamin Chan: None declared, Robert Suruki Employee of: UCB Pharma, Jeffrey Stark Employee of: UCB Pharma, Huifeng Yun Grant/research support from: Bristol-Myers Squibb and Pfizer, Sarah Siegel: None declared, Lang Chen: None declared, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corona, Crescendo, Genentech, Janssen, Pfizer, Roche and UCB Pharma