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1
Barnett, K. C., and E. C. Joseph. "Keratoconjunctivitis Sicca in the Dog Following 5-Aminosalicylic Acid Administration." Human Toxicology 6, no. 5 (September 1987): 377–83. http://dx.doi.org/10.1177/096032718700600506.
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1 Keratoconjunctivitis sicca (KCS) is an inflammatory eye condition, affecting the cornea and conjunctiva, caused by a deficiency in the aqueous fraction of tears. The condition is relatively common in the dog with a varied aetiology. A number of drugs have been implicated in the production of KCS in the dog including salicylazosulphapyridine (sulphasalazine). 2 This paper details clinically evident KCS in a 12-month oral toxicity study with 5-aminosalicylic acid (5-ASA), the therapeutically active metabolite of sulphasalazine. 3 The condition was first diagnosed at study week 22 and subsequently progressed both in incidence and severity. There was a distinct sex-difference in the response, with treated females being more affected than males. 4 There was a close correlation between the production of KCS and reduced lacrimation as assessed by the Schirmer tear test. 5 Although sulphasalazine causes KCS in dogs there have been no reports of ocular lesions of this type in man with this drug. It is highly probable that the dog is not a predictive model for man with regard to KCS induction by sulphasalazine or its metabolite 5-ASA.
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Afsar, NS, MMN Khan, MMH Chowdhury, SA Haq, M. Khalilur Rahman, and MMR Khan. "A Comparative Study on Efficacy of Methotrexate and Sulphasalazine in Spondyloarthropathies." TAJ: Journal of Teachers Association 24, no. 1 (June 30, 2011): 43–47. http://dx.doi.org/10.3329/taj.v24i1.37449.
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Background: Spondyloarthropathies include a wide spectrum of disease. The study was conducted with the aim of observing the efficacy of SSZ and MTX in different subclasses of spondyloarthropathies and to compare the treatment response of the two drugs.
Methods: This study was conducted in the Department of Medicine and Rheurnatology clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU) between January 1999 and July 2001.A total number of one hundred twenty five patients was included in the study. Patients with active disease more than three months, regularly taking NSAIDs and not on DMARD in the last three months were included in the study. Monthly follow up of the patients was done for 6 months.
Result: One hundred twenty five patients were included in this study. Male female ratio was 11.5:1. Mean age of patients was 24.17±7.15 years. The mean disease duration was 47.8±32.8 months. The present study categorized the patients into responder and non responder. Among the 78 patients in AS subclass, after completion of 6 month trial 55.6% patients in SSZ group and 39.4% patients in MTX group were categorized responder. The difference of response between drug groups was not significant (p=0.158). In the JCA subclass 81.82% in SSZ and 50% in MTX group were responder. The numbers of patient in Reiter's/Reactive Arthritis in our study were too small to make a definite comment.
Conclusion: It can be concluded from this study that both the SSZ and MTX are effective DMARDs for spondyloarthropathies. Statistical analysis did not prove superiority of one drug over another, though the response rates were numerically higher in SSZ group.
TAJ 2011; 24(1): 43-47
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Helene Ibfelt, E., R. Kart Jacobsen, T. I. Kopp, R. Cordtz, A. Svarre Jakobsen, N. Seersholm, S. Burhan Shaker, and L. Dreyer. "OP0232 TREATMENT WITH METHOTREXATE AND RISK OF LUNG DISEASE IN PATIENTS WITH RHEUMATOID ARTHRITIS: A NATIONWIDE POPULATION-BASED COHORT STUDY FROM DENMARK." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 147–48. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1609.
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Background:Methotrexate (MTX) is the recommended first-line drug in EULAR and ACR treatment guidelines for rheumatoid arthritis (RA) and hence the most commonly prescribed DMARD in the treatment of this group of patients. However, lung disease is considered a potential adverse effect of MTX treatment.Objectives:To investigate the risk of interstitial lung disease (ILD) and acute and chronic respiratory failure in RA patients treated with MTX and other medications.Methods:From the Danish National Patient Register (DNPR) and the clinical DANBIO Register for rheumatic diseases, we retrieved data on RA patients registered between 1997 and 2015. Information on ILD and respiratory failure outcomes was obtained from DNPR, and information on redeemed prescriptions for MTX and other medications was obtained through linkage to the Danish Prescription Register. Associations between MTX and lung disease outcomes were analyzed in Cox regression models adjusted for age, calendar time, sex and use of other medications possessing the potential for pulmonary toxicity. Standardized Incidence Ratios (SIRs) of lung disease were calculated to compare RA patients to the general population.Results:Of the 30,512 RA patients identified, 60% patients had redeemed at least one prescription for MTX, 35% had redeemed a prescription for sulphasalazine, 6% had redeemed a prescription of either amiodarone or nitrofurantoin, and 27% had not received any of the included drugs at the end of the 5-year follow-up for ILD and respiratory failure. MTX treatment was not associated with an increased risk of lung disease (≥1 redeemed prescription(s) compared to no prescriptions), HR 1.00 (95% CI 0.78 to 1.27) for ILD and 0.54 (95%CI 0.43 to 0.67) for respiratory failure at 5-year follow-up (Table). The SIR was 3-4 times increased for ILD in MTX-treated RA patients, but this was no different from the RA population in general compared to the background population.Table.Hazard ratios (HR) with 95% confidence intervals (95%CI) for the risk of interstitial lung disease (ILD) and acute or chronic respiratory failure in 30,512 patients with rheumatoid arthritis up to 5 years after diagnosis.ILD (incl. drug-induced cases)1 year of follow up5 years of follow upEvents, NHR (95% CI)Events, NHR (95% CI)Methotrexate, ≥1 redeemed prescription(s) vs. none621.03 (0.71 to 1.48)1661.00 (0.78 to 1.27)Sulphasalazine, ≥1 redeemed prescription(s) vs. none210.88 (0.54 to 1.43)901.14 (0.89 to 1.48)Amiodarone and/or nitrofurantoin, ≥1 redeemed prescription(s) vs. none10.57 (0.08 to 4.10)70.65 (0.31 to 1.38Women72Ref.155Ref.Men551.51 (1.06 to 2.16)1301.74 (1.38 to 2.21)Acute or chronic respiratory failure1-year of follow up5-years of follow upEvents, NHR (95% CI)Events, NHR (95% CI)Methotrexate, ≥1 redeemed prescription(s) vs. none360.48 (0.32 to 0.73)1580.54 (0.43 to 0.67)Sulphasalazine, ≥1 redeemed prescription(s) vs. none140.70 (0.39 to 1.26)991.09 (0.86 to 1.38)Amiodarone and/or nitrofurantoin, ≥1 redeemed prescription(s) vs. none63.01 (1.31 to 6.94)221.33 (0.86 to 2.06)Women71Ref.239Ref.Men381.07 (0.72 to 1.59)1201.04 (0.83 to 1.29)Conclusion:RA patients had an increased risk of ILD compared to the general population, but that risk was not further increased in patients treated with MTX compared to non-MTX treated.Disclosure of Interests:None declared
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Mukherjee, Dibyendu, Suman Nandi, Soumyabrata Roy Chaudhuri, Sucharita Patra, and Mithun Roy. "Prescription audit of rheumatoid arthritis patients treated at primary and secondary care level, before reaching a tertiary care centre hospital in Eastern India." International Journal of Advances in Medicine 7, no. 5 (April 23, 2020): 770. http://dx.doi.org/10.18203/2349-3933.ijam20201564.
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Background: To analyse the usage pattern of pharmacological agents in the treatment of rheumatoid arthritis in Eastern India at a community level before reaching a specialized rheumatology clinic.Methods: Total 200 patients earlier diagnosed to be RA on treatment were selected and their demographic details, duration of treatment, agents prescribed, adverse drug reactions (ADRs) were analysed.Results: At the end of the study analysis, we observed that HCQ (24.4%) and Sulphasalazine (20.9%) were the commonest disease modifying anti-rheumatoid drug (csDMARD) used, followed by Methotrexate (16.9%). Dual combination csDMARD (33.1%) was preferred. Biological therapy was a rarity (0.5%). Steroids (21.0%) and NSAIDs (22.5%) was commonly used. Complementary and Alternative Medicines (CAM) (44.0%) was used often. Polypharmacy was the trend. Not all patients diagnosed as RA met the 2010 ACR/EULAR classification criteria of RA.Conclusions: In 15% patients, the diagnosis of RA was inappropriate according to the recent classification criteria. csDMARD was preferred either as monotherapy or combination therapy. Use of steroids and NSAID was a common practice. ADR were mild in severity.
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Duran, E., E. Bilgin, E. C. Bolek, G. K. Yardimci, B. Farisoğullari, L. Kiliç, A. Akdoğan, et al. "FRI0336 CONCOMITANT USE OF BIOLOGIC DMARDS WITH CSDMARDS INCREASES DRUG RETENTION RATE AND IMPROVES TREATMENT RESPONSE IN THE PSORIATIC ARTHRITIS. HUR-BIO REAL LIFE RESULTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 761.2–761. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4782.
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Background:For inflammatory arthritis, drug retention is accepted as an important indicator of the effectiveness and safety of biological drugs.Objectives:The objective of this study was to determine of the effects first and overall bDMARD drug retention rate during concomitant csDMARD in psoriatic arthritis (PsA).Methods:HUR-BIO (Hacettepe University Rheumatology Biologic Registry) is a prospective, single center database of biological treatments since 2005. All PsA patients (469) who enrolled in HUR-BIO registry and prescribed at least once biologic DMARD (bDMARD) were included in the study. The subjects were divided into two groups depending on whether or not to use csDMARDs (methotrexate, sulphasalazine or leflunomide) at the last control visit. Demographic, clinical and therapeutic data were collected from this database. Baseline disease activity before the first bDMARD initiation was assessed with DAPSA and PsAID-12.Table.Demographics, baseline and follow-up clinical characteristics of PsA patientsWith concomitant csDMARD n=288Without concomitant csDMARD n=167pAge (mean, SD)48.9 (12.1)45.1 (12.4)0.002Female n (%)204 (70.8)113 (67.7)0.48PsA disease duration (med, IQR)7 (13)7 (14.5)0.53Age at PsA diagnosis (mean, SD)39 (11.7)40.8 (12.9)0.81BMI (mean, SD)29.6 (6.0)29.2 (5.9)0.53Axial involvement n (%)68 (34.0)37 (44.6)0.09HLA-B 27 (+) n (%)21/76 (27.6)17/69 (24.6)0.68Duration of use first bDMARD (months) (med, IQR)22.4 (51.3)14.1 (31.4)0.003Duration of use overall bDMARD (months) (med, IQR)56.8 (69.4)24.4 (57.7)<0.001Switching bDMARD (+) n (%)148 (52.5)71 (42.8)0.04Initial DAPSA1(med, IQR)19.4 (11.7)17.3 (10.2)0.04Initial PSAID2(med, IQR)5.7 (3)5.6 (2.8)0.55Final visit PSAID3(med, IQR)2.8 (3.8)2 (5.7)0.41Final visit DAPSA4(med, IQR)Remission (n,%)Low disease activityModerate disease activityHigh disease activity10.2 (12.4)12.5 (12.5)0.01Remission (n,%)61 (23.9)111 (43.5)72 (28.2)11 (4.3)27 (17.6)59 (38.6)58 (37.9)9 (5.9)0.13Low disease activity111 (43.5)59 (38.6)Moderate disease activity72 (28.2)58 (37.9)High disease activity11 (4.3)9 (5.9)1: n=249,2: n=214,3: n=109,4: n=408p<0.001p=0.003Results:HUR-BIO PsA registry included 469 PsA patients. Baseline, clinical characteristics and follow-up parameters were given in Table. The using overall bDMARD were adalimumab 294 (62.0%), etanercept 135 (28.8%), infliximab 119 (25.4%), certolizumab pegol 107 (22.8%), secukinumab 67 (14.3%), golimumab 58 (12.4%), ustekinumab 25 (5.3%) and tofacitinib 11 (2.3%). Two hundred eighty eight (61.4%) patients used concomitant cDMARDs [methotrexate 176 (37.5%), leflunomide 94 (20.0%), sulphasalazine 35 (7.5%) and two csDMARD combination 17 (3.6%)]. The first-year retention rate of first bDMARD with or without concomitant csDMARDs were 88% and 80%, respectively. The median duration of first bDMARD retention with or without concomitant csDMARDs were 131.7 and 91.4 months, respectively (Figure). The first-year retention rate of overall bDMARDs with or without concomitant csDMARDs were 92% and 85%, respectively. The median drug retention rate of overall bDMARD in using csDMARD and not using csDMARD were 141.5 and 131.5 months, respectively. Retention rates (both for first bDMARD and overall bDMARDs) were significantly higher in concomitant csDMARDs using group (p=0.003 for first bDMARD retention, p<0.001 for overall bDMARDs retention, log-rank; Figure). In concomitant csDMARD using group, no differences were identified methotrexate or other csDMARDs.Conclusion:In this study, csDMARDs, either methotrexate or leflunomide/sulphasalazine have additional effect for both retention rate and treatment response of bDMARDs. On the other hand, using bDMARD monotherapy is relatively higher than rheumatoid artritis (1).Figure.Drug retention rate of the first bDMARD and overall bDMARDs according to concomitant csDMARD use (csDMARD:conventional synthetic Disease Modifiying Antirheumatic Drug)Disclosure of Interests:Emine Duran: None declared, Emre Bilgin: None declared, Ertugrul Cagri Bolek: None declared, Gözde Kübra Yardimci: None declared, Bayram Farisoğullari: None declared, Levent Kiliç: None declared, Ali Akdoğan: None declared, Omer Karadag: None declared, Şule Arpaş Bilgen: None declared, Sedat Kiraz: None declared, Ali İhsan Ertenli: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB
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Proudman, Susanna M., Michael J. James, Llewellyn D. Spargo, Robert G. Metcalf, Thomas R. Sullivan, Maureen Rischmueller, Katerina Flabouris, Mihir D. Wechalekar, Anita T. Lee, and Leslie G. Cleland. "Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use." Annals of the Rheumatic Diseases 74, no. 1 (September 30, 2013): 89–95. http://dx.doi.org/10.1136/annrheumdis-2013-204145.
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BackgroundThe effects of fish oil (FO) in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA. This study examined the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).MethodsPatients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.ResultsIn the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.ConclusionsFO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.
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Carmona, L., J. Weaver, E. Burn, B. Illingens, D. Vizcaya, R. Sawant, T. Duarte-Salles, P. Ryan, and D. Prieto-Alhambra. "SAT0138 DRUG-RELATED PANCYTOPENIA AND LEUKOPENIA IN RHEUMATOID ARTHRITIS: ARE ALL CSDMARDS EQUAL?" Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1006–7. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4075.
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Background:Cytopenia is a known side-effect of conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in rheumatoid arthritis (RA). There is a lack of data on the comparative risk of cytopenia with different csDMARDs.Objectives:To assess the comparative risk of leukopenia and pancytopenia for the most frequently used first-line csDMARDs: methotrexate (MTX), hydroxychloroquine (HCQ), sulphasalazine (SSZ), and leflunomide (LEF).Methods:The study used data from 7 databases from 4 countries: CCAE, MDCR, Optum, IQVIA Ambulatory EMR (US); IQVIA THIN IMRD EMR (UK); IQVIA Disease Analyzer EMR (Germany); and SIDIAP (Spain). Cohorts included adult patients with a diagnosis of RA from 2005 to 2019 with at least one-year prior follow-up, no prior inflammatory arthritis, initiaton of first-line csDMARD, and no cytopenia in the preceding 30 days. Participants were followed from one day after treatment initiation to the earliest of event occurrence, treatment discontinuation/switching plus 14 days in the on-treatment analysis, five years in the intent-to-treat (ITT) analysis, or loss to follow-up. MTX was used as reference group. Cox models were fitted with propensity score stratification for observed confounding and negative control outcomes calibration for residual error. Estimates across database were pooled where I2<40% was seen.Results:Overall 166,347 patients were included. Pooled rates of leukopenia and pancytopenia for MTX were 10.9 and 3.2 per 1,000 person years, respectively. Figure 1 and 2 show the results for the different databases and pooled estimates where applicable. Database estimates are not reported where adequate covariate balance not attained, and meta-analysis not shown where I2>0.4. MTX showed slightly higher hazards of leukopenia and of pancytopenia compared to LEF but no consistently differential risks compared to HCQ or SSZ.Figure 1.Calibrated hazard ratios (95% CI) vs MTX, on-treatment analysisConclusion:Cytopaenia is rare, and apparently more frequent with MTX and less with LEF. Since prior full blood counts were inconsistently obtained in fewer than 50% of csDMARD new users (e.g. more frequent in MTX [42%] than HCQ [32%] in CCAE and Optum; roughly equal in MDCR), these results should inform future monitoring recommendations.Figure 2.Calibrated hazard ratios (95% CI) vs MTX, ITT analysisDisclosure of Interests:Loreto Carmona Grant/research support from: Novartis Farmaceutica, SA, Pfizer, S.L.U., Merck Sharp & Dohme España, S.A., Roche Farma, S.A, Sanofi Aventis, AbbVie Spain, S.L.U., and Laboratorios Gebro Pharma, SA (All trhough institution), James Weaver Shareholder of: J&J Shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Edward Burn: None declared, Ben Illingens: None declared, David Vizcaya Employee of: Bayer, Ruta Sawant Shareholder of: AbbVie, Employee of: AbbVie, Talita Duarte-Salles: None declared, Patrick Ryan: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen
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Yasar Bilge, N. S., T. Kaşifoğlu, S. Kiraz, A. İ. Ertenli, E. Dalkiliç, C. Bes, H. Emmungil, et al. "AB0650 BIOSIMILAR INFLIXIMAB EXPERIENCE IN SPONDYLOARTRITIS PATIENTS: TREASURE REAL LIFE RESULTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1620.2–1620. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3918.
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Background:Biosimilar infliximab (bio-INF) was approved for all indications of the reference product in several countries. It has been marketed since 2014 in Turkey and used in the same indications with its bio-originator.Objectives:Herein, we aimed to analyse clinical features and the drug survival rates of spondyloarthritis patients who have recieved bio-INF.Methods:This multicenter, prospective observational cohort study used the TReasure database in which web-based registration of rheumatoid arthritis and SpA patients are being performed in 13 centers across different regions of Turkey. Age, gender, and acute phase responses (erythrocyte sedimentation rate and C-reactive protein), HAQ scores, VAS patient global, VAS fatigue, VAS pain, VAS physician global, BASDAI, BASFI, ASDAS ESH and ASDAS CRP values, clinical findings of SpA patients, number of patients who has received bio-INF as first line therapy or after switch, treatments which are used before bio-INF, the reasons for switching bio-INF to another biologic DMARD and drug survival rates were retrospectively evaluated.Results:A total number of 231 SpA (94 (40.7 %) female, 137 (59.3%) male, mean age 43±11 yrs) patients have received biosimilar infliximab in the database. Of the 231 patients 127 (55%) had received bio-INF as first line therapy, whereas 104 (46 (19.9%) 2ndchoice, 58 (25.1%) 3rdchoice) patients used switching after another biologic DMARD. Previously used biologic and synthetic DMARDs were adalimumab (28.6%), etanercept (22.5%), golimumab (9.1%), original infliximab (8.2%), secukinumab (13.4%), methotrexate (23.8%), leflunamid (10.4%), sulphasalazine (60.6%). The baseline and first visit (3. Months) diseases activity scores were shown in Table 1. Drug survival rates were 79.1 in 12. months, 65.5 in 24. months and 54.6 in 60. months. (Figure 1). The most common reasons for switching from biosimilar infliximab to another biologic DMARD is secondary (25(10.8%)), and primary ineffectiveness (22(9.5%)). Other reasons to discontinuation of treatment are psoriasis (5 (2.1%)), infusion reaction (3(1.2%)), allergic reaction (22(8.8 %)), chest pain (3(1.2%)), dyspnea (1 (0.4%)), vasculitis (1 (0.4%)) and patient or doctor wish (7 (3.4%)).Conclusion:The results of this real life data provides evidence that biosimilar infliximab is an effective and safe treatment option with long term use in SpA patients. Drug survival rates of bio-INF is similar to its bio-originator.Table 1.Disease activity scoresBaseline visit3.monthpmedian (Q1-Q3)median (Q1-Q3)HAQ score0,63 (0,4-1)0,25 (0-1)<0,001BASDAI6,2 (4,8-7)2,8 (1-5)<0,001BASFI5,05 (3,3-6)2,1 (0,45-4)<0,001VAS Patient Global70 (50-80)30 (10-50)<0,001VAS Doctor Global60 (40-70)30 (20-40)<0,001VAS Pain50 (3-80)30 (10-50)0,572VAS fatigue70 (50-80)40 (10-65)<0,001ESR24 (11-45)11 (6-23)<0,001CRP12,1 (4,4-30)3,91 (2,19-9)<0,001ASDAS ESR3,12 (2,51-4)2,05 (1,39-3)<0,001ASDAS CRP3,53 (2,86-4)2,21 (1,5-3)<0,001*Wilcoxon Signed Rank TestFigure 1.Drug survival ratesDisclosure of Interests:Nazife Sule Yasar Bilge: None declared, Timuçin Kaşifoğlu: None declared, Sedat Kiraz: None declared, Ali İhsan Ertenli: None declared, Ediz Dalkiliç: None declared, Cemal Bes: None declared, Hakan Emmungil: None declared, Belkis Nihan Seniz: None declared, Burcu Yağiz: None declared, Muhammet Çinar: None declared, Servet Akar: None declared, Önay Gerçik: None declared, Duygu Ersözlü: None declared, Gezmiş Kimyon: None declared, Ridvan Mercan: None declared, Omer Karadag: None declared, Yavuz Pehlivan: None declared, Levent Kiliç: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB
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Haroon, M., S. Batool, S. Asif, F. Hashmi, and S. Ullah. "AB0533 COMBINATION OF METHOTREXATE AND LEFLUNOMIDE IS SAFE AND HAS GOOD DRUG RETENTION AMONG PATIENTS WITH PSORIATIC ARTHRITIS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1298.1–1298. http://dx.doi.org/10.1136/annrheumdis-2021-eular.978.
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Background:Among patients with psoriatic arthritis (PsA), there remains a considerable confusion regarding the effectiveness of conventional synthetic DMARDs (csDMARDs), especially methotrexate (MTX). The availability of biologic DMARDs and targeted synthetic DMARDs have revolutionised the management of psoriatic disease; however, it comes with a significant cost burden. We believe that combination of DMARDs, especially combining MTX and Leflunomide (LEF) provides a valuable low-cost treatment option for patients with PsA after failure of MTX monotherapy. Hence, in our practice, we are inclined to use combination of potent DMARDs after MTX failure, prior to considering biologic therapies. Little is known about the combination use of LEF and MTX in PsA, especially in the context of drug retention time and tolerability.Objectives:We aimed to review our PsA cohort data especially examining the drug retention of first-line csDMARD monotherapy and combination csDMARDs.Methods:In our centre, MTX is a preferred first line csDMARD, unless contraindicated, and patients are followed up with a protocol on 4-6 weekly basis unless complete remission is achieved. MTX if needed is escalated to the maximum tolerated dose (up to 25mg/week), and if PsA is still active then preferably LEF is added (usual starting dose for add-on therapy is 10mg a day and if needed escalated to 20mg a day, without any loading dose). Other csDMARDs, such as sulphasalazine are used, if needed. For this study, after written-informed consent, only those adult patients were included who had a follow up of at least 6 months with our rheumatology services, and were fulfilling CASPAR criteria. Moreover, only patients who were DMARD-naïve (no prior DMARD therapy for any cause, including psoriasis), and initiated DMARD as monotherapy after 1 April 2018 were included. If any patient had already been on any DMARDs prior to attending our rheumatology services was excluded.Results:A total of 81 PsA patients [mean age 45.6±6 years; 52% male; mean PsA disease duration=9±4 years; 35% with dactylitis, 42% with enthesitis, 17% with sacroiliitis, median current PASI=2.6, median number of swollen joints=8.0, median number of tender joints= 11.0] fulfilled the inclusion and exclusion criteria. As regards first-line csDMARD monotherapy, 88% (n=71) of patients were commenced on MTX. In total, 79% (n=56 out of 71) of patients who were started on MTX as their first-line csDMARD therapy failed this monotherapy during follow-up (51=ineffective, 5=intolerance). After a median follow-up of 22 months, MTX median drug retention among all MTX monotherapy users (n=71) was only 7 months (IQR 5-7); and among MTX failures (n=56), MTX monotherapy median drug retention was 6.0 months (IQR 4-8). Eighty percent (n=45 out of 56) of the MTX monotherapy failure cohort was started on combination therapy of MTX and LEF (combo MTX+LEF); among them, only 7 patients needed escalation of therapy to bDMARDs, and the rest are still using combo MTX+LEF. It was noted that to date median drug retention time of combo MTX+LEF has been 8 months (IQR 7-11), and 84% (n=38 out of 45) of these patients are still using this combo therapy. Significantly more patients managed to continue the combo MTX+LEF therapy compared to MTX monotherapy (84% vs. 21%, p<0.001)Conclusion:Among csDMARD naïve PsA patients, 79% of patients failed MTX monotherapy with median drug retention time of only 6 months. Combination of MTX and LEF was well tolerated and had good drug retention time, with 84% of patients having ongoing treatment to date. Our data provides initial evidence that MTX and LEF combination therapy could be an effective treatment option for PsADisclosure of Interests:Muhammad Haroon Speakers bureau: Roche, Novartis, Grant/research support from: Abbvie, Pfizer, Shabnam Batool: None declared., Sadia Asif: None declared., Farzana Hashmi: None declared., Saadat Ullah: None declared.
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Murayama, Takasi, and Satosi Nakasaki. "A study on effectiveness of sulphasalazine for rheumatoid arthritis - A comparison with other oral remission inducing drugs." Ensho 8, no. 6 (1988): 555–60. http://dx.doi.org/10.2492/jsir1981.8.555.
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Banerjee, Antara, Marco Scarpa, Surajit Pathak, Patrizia Burra, Giacomo C. Sturniolo, Francesco P. Russo, Ram Murugesan, and Renata D'Incá. "Inflammatory Bowel Disease Therapies Adversely Affect Fertility in Men- A Systematic Review and Meta-analysis." Endocrine, Metabolic & Immune Disorders - Drug Targets 19, no. 7 (October 11, 2019): 959–74. http://dx.doi.org/10.2174/1871530319666190313112110.
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Background and Aims: Sexual functions are sometimes adversely affected by the therapeutic drugs delivered for treating IBD. Much attention has been focused on pregnancy/sexual issues in women. Relatively less attention has been poured in to address this issue in men. This systematic review assesses the drugs having potential detrimental effects on fertility in men. Methods: Three databases were searched by two researchers independently for potentially relevant publications between 1964 to 2015 and 249 papers were retrieved. Studies that dealt with sexual problems after IBD drugs administration were included in the purview of this review. Results: Fourteen studies with 327 human patients and 110 animals were analysed. Sulphasalazine treated patients had lower spermatozoa count, lower sperm motility and higher risk of oligospermia compared to mesalazine treated ones. Biologics seem to be safe to use while attempting to conceive however, proper clinical studies reporting male fertility problems in IBD patients are lacking. Azathioprine caused oligospermia but a meta-analytical approach was not possible due to heterogeneity in studies. Some animal studies showed methotrexate affects abnormal testis structure and spermatogenesis. Conclusion: This study summarises the current literature and safety issues affecting fertility parameters in men and animals treated with IBD therapeutic drugs, which can further assist clinicians in better management of adult male IBD patients.
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Bobirca, Anca, Ioan Ancuta, Florin Bobirca, Cristina Tataru, Cristina Comsa, Carina Mihai, Mihai Bojinca, and Victor Stoica. "BREASTFEEDING IN RHEUMATOID ARTHRITIS IN ROMANIA." Romanian Journal of Rheumatology 25, no. 4 (December 31, 2016): 199–203. http://dx.doi.org/10.37897/rjr.2016.4.5.
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Background. Rheumatoid arthritis (RA) is not a contraindication to pregnancy. It is only mandatory to observe several recommendations: planning pregnancy, adapting anti-rheumatic medication and monitoring disease activity every trimester. Postpartum, RA often relapses, therefore, breastfeeding can be exposed to anti-rheumatic drugs. Only Methotrexate, Leflunomide and Cyclophosphamide are fully contraindicated during lactation. TNF inhibitors are compatible with breastfeeding, while other biological therapies are not recommended, due to the lack of data. Objectives. This study aimed to evaluate pregnancy outcomes among female patients with RA, who attended rheumatology clinics from different Romanian cities. Secondary objectives were disease course and anti-rheumatic medication post-partum, the occurrence of RA postpartum flares and the adherence to breastfeeding. Patients and methods. This is a pilot observational, multicentric study, performed between October 2012 and July 2016. We have analyzed 41 patients diagnosed with RA before conception and who had at least one pregnancy after diagnosis. We recorded the pregnancy outcome, and, regarding the postpartum period, the occurrence of disease relapse and the antirheumatic medication exposure during lactation. Results. The 41 patients had 72 pregnancies, with 39 deliveries resulting in 42 healthy infants; 30 patients chose to breastfeed. Postpartum, the disease relapsed in 23/30 patients after a mean of 9.56 weeks. Therefore, these infants were exposed to anti-rheumatic drugs during lactation (anti-inflammatory drugs, Sulphasalazine and Hydroxicloroquine). No biological therapy was administrated during breastfeeding. Conclusion. The data obtained regarding the relapse risk and breastfeeding while using antirheumatic drugs are generally within international recommendations. We need more experience to be able to manage difficult situations and to take the best decision for our female patients with RA.
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Fornaciari, Giovanni, Carlo Salvarani, Marina Beltrami, PierLuigi Macchioni, Reinhold W. Stockbrügger, and Maurice G. Russel. "Musculoskeletal Manifestations in Inflammatory Bowel Disease." Canadian Journal of Gastroenterology 15, no. 6 (2001): 399–403. http://dx.doi.org/10.1155/2001/612531.
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Muscoloskeletal manifestations are the most common extraintestinal complications of inflammatory bowel disease. Wide ranges in prevalence have been reported, depending on the criteria used to define spondylarthropathy. In 1991, the European Spondylarthropathy Study Group developed classification criteria that included previously neglected cases of undifferentiated spondylarthropathies, which had been ignored in most of the oldest epidemiological studies on inflammatory bowel disease. The spectrum of muscoloskeletal manifestations in inflammatory bowel disease patients includes all of the clinical features of spondylarthropathies: peripheral arthritis, inflammatory spinal pain, dactylitis, enthesitis (Achilles tendinitis and plantar fasciitis), buttock pain and anterior chest wall pain. Radiological evidence of sacroiliitis is common but not obligatory. The articular manifestations begin either concomitantly or subsequent to the bowel disease; however, the onset of spinal disease often precedes the diagnosis of inflammatory bowel disease. The prevalence of the different muscoloskeletal manifestations is similar in ulcerative colitis and Crohn's disease. Symptoms usually disappear after proctocolectomy. The pathogenetic mechanisms that produce the muscoloskeletal manifestations in inflammatory bowel disease are unclear. Several arguments favour an important role of the intestinal mucosa in the development of spondylarthropathy. The natural history is characterized by periods of flares and remission; therefore, the efficacy of treatment is difficult to establish. Most patients respond to rest, physical therapy and nonsteroidal anti-inflammatory drugs, but these drugs may activate bowel disease. Sulphasalazine may be recommended in some patients. There is no indication for the systemic use of steroids.
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Baset, Md Abdul, Bidhu Bhusan Das, Devendra Nath Sarkar, Mainuddinin Ahmed, Md Ismail Hossain, Mirza Sumaiya Tanzin, Mst Fahmiah Begum, Md Abdul Ohab, Md Shafiul Alam, and Mahfuzer Rahman. "Effectiveness of Methotrexate and Salfasalazine Alone Versus Methotrexate and Sulphasalazine Combination in the Treatment of Rheumatoid Arthritis." Bangladesh Journal of Medicine 26, no. 2 (November 10, 2015): 67–75. http://dx.doi.org/10.3329/bjmed.v26i2.25451.
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Background: Rheumatoid arthritis is a chronic, autoimmune, inflammatory disorder of unknown aetiology that is characterized by symmetric synovitis and the propensity to cause joint destruction, disability and premature death. Disease-modifying anti-rheumatic drugs (DMARDs) slow the natural course of the disease, reduce joint damage and pain, and retard loss of function and disability. Disease modifying agents should be started as early as possible. A number of studies demonstrating the effectiveness of combinations of DMARDs in early RA.Methods: This is a comparative descriptive type of study was conducted in the Department of Medicine, Rangpur Medical College and Hospital, Rangpur & Medicine Specialists Chambers, Rangpur, over a period of 2 (two) years from July 2010 to June 2012 on newly diagnosed RA patients on the basis of ACR criteria. The 30 patients were divided into 3 groups. Group I got MTX, Group II got SSZ and Group III got MTX & SSZ. Purposive consecutive sampling method was employed. The objective of the study was to evaluate the outcome of patients of rheumatoid arthritis treated with MTX or SSZ alone versus MTX and SSZ in combination. The primary outcome measure was change in DAS28.Results: The mean DAS 28 score baseline was found 7.23±0.44 in group I, 7.29±0.39 in group II and 7.86±0.41 in group III. The mean DAS 28 score end of the study was 4.24±0.39 in group I, 4.85±0.54 in group II and 3.08±0.36 in group III. The difference was statistically significant (P<0.001) among the three groups. There is no toxicity found in any group. Regarding side effects, the difference was not statistically significant (P>0.05) among the three groups.Conclusion : This study suggests that the mean changes in the DAS28 score significantly lower in those who received combination therapy compared with those who received either MTX or SSZ alone during one year follow up.Bangladesh J Medicine Jul 2015; 26 (2) : 67-75
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Pazmino, Sofia, Annelies Boonen, Veerle Stouten, Diederik De Cock, Johan Joly, Kristien Van der Elst, Rene Westhovens, and Patrick Verschueren. "Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial." Annals of the Rheumatic Diseases 79, no. 5 (April 2, 2020): 556–65. http://dx.doi.org/10.1136/annrheumdis-2019-216874.
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ObjectivesTo evaluate the cost-effectiveness of treat-to-target strategies among recently diagnosed patients with rheumatoid arthritis (RA) using methotrexate (MTX) and a step-down glucocorticoid (GC) scheme (COBRA Slim) compared with (1) this combination with either sulphasalazine (COBRA Classic) or leflunomide (COBRA Avant-Garde) in high-risk patients and (2) MTX without GCs (Tight-Step-Up, TSU) in low-risk patients.MethodsThe incremental cost-utility was calculated from a healthcare perspective in the intention-to-treat population (n=379) of the 2-year open-label pragmatic randomised controlled Care in early RA trial. Healthcare costs were collected prospectively through electronic trial records. Quality-adjusted life years (QALYs) were estimated using mapping algorithms for EuroQoL-5 Dimension. Multiple imputation was used to handle missing data and bootstrapping to calculate CIs. Robustness was tested with biological disease-modifying antirheumatic drugs at biosimilar prices.ResultsIn the high-risk group, Classic (∆k€1.464, 95% CI −0.198 to 3.127) and Avant-Garde (∆k€0.636, 95% CI −0.987 to 2.258) were more expensive compared with Slim and QALYs were slightly worse for Classic (∆−0.002, 95% CI −0.086 to 0.082) and Avant-Garde (∆−0.009, 95% CI −0.102 to 0.084). This resulted in the domination of Classic and Avant-Garde by Slim. In the low-risk group, Slim was cheaper (∆k€−0.617, 95% CI −2.799 to 1.566) and QALYs were higher (∆0.141, 95% CI 0.008 to 0.274) compared with TSU, indicating Slim dominated. Results were robust against the price of biosimilars.ConclusionsThe combination of MTX with a GC bridging scheme is less expensive with comparable health utility than more intensive step-down combination strategies or a conventional step-up approach 2 years after initial treatment.Trial registration numberNCT01172639.
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Prats-Uribe, A., B. Illingens, D. Vizcaya, J. Weaver, E. Burn, R. Sawant, K. Marinier, P. Ryan, and D. Prieto-Alhambra. "SAT0131 CARDIO- AND CEREBROVASCULAR RISK WITH CONVENTIONAL SYNTHETIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (CSDMARDS) IN RHEUMATOID ARTHRITIS (RA): A REAL-WORLD COMPARATIVE ASSESSMENT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1002. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3463.
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Background:RA is associated with an increased cardiovascular (CV) risk. csDMARDs are first-line treatments for RA and can mitigate this risk, but limited data exist on their CV effects. Previous trials have reported protective effects for methotrexate (MTX) and hydroxychloroquine (HCQ), but no similar data exist on sulfasalazine (SSZ) or leflunomide (LEF).Objectives:To assess the comparative effect of csDMARDs on the risk of myocardial infarction (MI) and stroke in RA patientsMethods:Data from 6 claims/electronic health records databases across Germany, US, and UK, all mapped to the Observational Medical Outcomes Partnership (OMOP) common data model. A cohort study was conducted including patients ≥18 years old, with first RA diagnosis in 2005-2019, initiating csDMARD monotherapy with MTX, HCQ, SSZ, or LEF. Those with a prior diagnosis of other inflammatory arthritis or <1 year prior follow-up were excluded. Patients were followed until first outcome, death, loss of or 5 years follow-up. Propensity score stratification was used, and hazard ratios (HR) estimated for HCQ, SSZ and LEF compared to MTX in each dataset using Cox regression. HR were calibrated (cHR) for residual confounding using negative control outcomes. Estimates were pooled where I2for heterogeneity <0.4. Intention to treat and an on treatment analyses are reported.Results:145,248 patients were included (MTX: 73,996, HCQ: 49,752, SSZ: 12,256, LEF: 9,244). Pooled rates of MI and stroke for MTX were 7.64 and 10.26 per 1,000 person years respectively. Detailed estimate cHRs are shown in Figure 1 for the intention to treat analysis. MI risk with SSZ and LEF was comparable to MTX. Risk of stroke was similar between LEF and MTX, but reduced for HCQ and SSZ compared to MTX, with pooled cHR (95% CI) 0.86 (0.78 to 0.95) and 0.71 (0.52 to 0.98) for HCQ and SSZ respectively. Similar results were found for “on treatment” analyses.Figure 1.Calibrated hazard ratios (cHRs) for MI and strokeConclusion:Overall, all four csDMARDs had similar effects on MI risk. HCQ and SSZ use were associated with a decreased risk of stroke compared to MTX. The observed differences may be attributable to differential effects on the atherosclerotic process, differential disease control, or both.Database estimates not reported where adequate covariate balance not attained. Meta-analysis results not reported where I2>0.4. MEDICARE did not pass diagnostics for SSZ and LEF analyses. cHR: calibrated Hazard Ratio; CI: Confidence Interval; MTX: Methotrexate; HCQ: Hydroxychloroquine; SSZ: sulphasalazine; LEF: Leflunomide; THIN: The Health Improvement Network (UK); Optum: Optum de-identified Clinformatics Datamart (US); MDCR: Medicare (US); GERMANY: IQVIA Disease Analyzer EMR (Germany); CCAE: IBM MarketScan Commercial Claims and Encounters (US); AMBEMR: IQVIA Ambulatory EMR (US)Database estimates not reported where adequate covariate balance not attained. Meta-analysis results not reported where I2>0.4. MEDICARE did not pass diagnostics for SSZ and LEF analyses. cHR: calibrated Hazard Ratio; CI: Confidence Interval; MTX: Methotrexate; HCQ: Hydroxychloroquine; SSZ: sulphasalazine; LEF: Leflunomide; THIN: The Health Improvement Network (UK); Optum: Optum de-identified Clinformatics Datamart (US); MDCR: Medicare (US); GERMANY: IQVIA Disease Analyzer EMR (Germany); CCAE: IBM MarketScan Commercial Claims and Encounters (US); AMBEMR: IQVIA Ambulatory EMR (US)Disclosure of Interests: :Albert Prats-Uribe: None declared, Ben Illingens: None declared, David Vizcaya Employee of: Bayer, James Weaver Shareholder of: J&J Shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Edward Burn: None declared, Ruta Sawant Shareholder of: AbbVie, Employee of: AbbVie, Karine Marinier Employee of: Servier, Patrick Ryan: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen
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McKee, P., A. Irvine, C. Riddell, and E. Ball. "OP0265-HPR IMPACT OF COVID-19 PANDEMIC ON RHEUMATOLOGY PATIENTS IN NORTHERN IRELAND – A WEB BASED CROSS-SECTIONAL SURVEY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 161.2–162. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3200.
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Background:Concern for the susceptibility of rheumatology patients to severe COVID-19 illness has been raised since the start of the pandemic. Rheumatic disease and their immunosuppressant therapies placed many patients into the ‘clinically extremely vulnerable’ group when the UK’s shielding guidance commenced on 23 March 2020. The impact of DMARDs/glucocorticoids/biologics on COVID-19 remains under investigation 1. A recent study suggested caution may be required with rituximab and sulfasalazine in COVID-19 patients 2.Objectives:The objective of this study is to evaluate the impact of the COVID-19 pandemic on rheumatology patients in Northern Ireland by assessing demographics, rheumatic disease, medications, disease progress, shielding advice, access to primary & tertiary care and incidence of COVID-19 infection.Methods:A web-based cross-sectional survey was completed in Northern Ireland. The study duration was between 23rd November 2020 and 22nd January 2021. The questionnaire included consent, demographic details, medication history, comorbidities, disease course, patient experience, shielding advice, COVID-19 illness and hospitalisation. The survey was publicised by sending 6,032 Belfast Trust NHS patients a link via SMS, posters were displayed in rheumatology departments, and links made available via NHS/Versus Arthritis social media platforms.Results:There were 2,615 responses and of these 2,539 had been completed and were analysed. Most respondents were aged 45+ (78.27%) and female (N=1819). Rheumatoid arthritis (41%) and psoriatic arthritis (29%) were the most common diagnoses. Just over one third (35.27%, N=896) of patients were on biological drugs. Most patients were taking methotrexate (28.04%) followed by hydroxychloroquine (15.20%) and adalimumab (12.52%). The majority (79.6%) continued treatment during the pandemic. There was evidence of disease ‘flaring’ in 30.75% of patients who had stopped treatment. Of the respondents surveyed 7.8% (N=198), tested positive for Covid-19 and of these 77.55% reported that they had received adequate shielding advice, primarily from GP or UK government sources. Only 11.11% (N=22) of those who tested positive for Covid-19 required hospital admission and 2 patients required intensive care support. Both patients requiring ICU were not on immunosuppression. Less than one third of patients testing positive for COVID-19 were on biological drugs (30.3%, N=60). Cardiovascular disease was the most prevalent comorbidity. Of the 22 patients hospitalised with COVID-19, 13.64% (N=3) were on solitary sulphasalazine therapy.Conclusion:The survey showed low levels of COVID-19 hospitalisation despite most patients continuing DMARD/biologic/glucocorticoid therapy. This has been replicated in other studies 1, however data continues to be gathered on the safety of some biologic drugs particularly rituximab 2. Most of our patients received clear understandable shielding guidance from a variety of sources. Many patients expressed fear of mortality, isolation and mental health issues. The survey findings indicated that stopping medication can have a negative impact on disease control.References:[1]Robinson PC, Yazdany J. The COVID-19 Global Rheumatology Alliance: collecting data in a pandemic. Nat Rev Rheumatol. 2020 Jun;16(6):293-294.[2]Strangfeld A, Schäfer M, Gianfrancesco MA, et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Annals of the Rheumatic Diseases Published Online First: 27 January 2021. doi: 10.1136/annrheumdis-2020-219498Disclosure of Interests:None declared
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Karjigi, U., C. Kodishala, S. Chandrashekara, S. Kumar, V. Haridas, S. R, R. Jois, et al. "AB0785 REAL LIFE EXPERIENCE OF METHOTREXATE BASED DUAL COMBINATION DMARDS IN PSORIATIC ARTHRITIS- RESULTS FROM KARNATAKA PSORIATIC ARTHRITIS COHORT (KPsAC)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1691.1–1691. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2081.
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Background:Biologics have been the focus of recent treatment guidelines and ‘Treat to Target’ strategies for both psoriasis (PsO) & psoriatic Arthritis (PsA). However, in day-today practice, combination DMARDs anchored around methotrexate are mainstay in majority of patients.Objectives:To describe experience and effectiveness of Methotrexate in combination with conventional DMARDs in Karnataka Psoriatic Arthritis Cohort.Methods:Treatment information was extracted from KPsAC (n=549) which is a cross sectional, non-interventional study conducted across 17 rheumatology practicing centres in Karnataka, India using a structured proforma. This study was approved by respective Ethical committee. Information on efficacy was extracted for various csDMARDs in combination with methotrexate. Standard disease activity outcome measures were used for assessing the response to therapy (DAPSA, PASI, HAQ, MDA5). All participating rheumatologists underwent training to calculate PASI and other outcome scores.Results:Nearly half of the patients in our cohort were on methotrexate (44%) monotherapy. Proportion of patients who received combination csDMARD anchored on methotrexate were 29%. The choice of add on csDMARD was as per clinician discretion or subject preference. Patients were divided in to three groups based on treatments they were receiving at the time of study: Methotrexate (Mtx)+Leflunomide (Lef), Mtx+Sulfasalazine (SSz) and Mtx+Apremilast(Apr). Their characteristics along with outcome measures are depicted in table 1. In Mtx+Apr group: remission or low disease activity was present in 42%, HAQ score of <0.5 was seen in 82%, and only one patient had a PASI of > 10. PASI was significantly lower in the Mtx+Apr group compared to Mtx+Lef group (p<0.009) and Mtx +Ssz group (p < 0.020)Conclusion:Apremilast is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4)**. In this observational study, 3 groups of methotrexate plus csDMARD- leflunomide, sulphasalazine and apremilast fared similarly for articular domain of PsA. However, in cutaneous domain, PASI was significantly lower in apremilast + methotrexate group. To our knowledge, this is the first real life report of the use of combination DMARDs in unselected PsA patients demonstrating effectiveness of apremilast in cutaneous domain. Methotrexate remains anchor DMARD for treatment of PsA in 2/3rdof PsA patients. Addition of apremilast to methotrexate inadequate responders appears to be beneficial in PsA with persistent cutaneous disease. However, being an observational study, this needs to be confirmed in controlled clinical trials.References:**Apremilast: A Review in Psoriasis and Psoriatic Arthritis, Drugs March 2017, Volume 77, Issue 4.Table.Characteristics and comparison of combination csDMARDsMTX+SSZ(N=39)MTX+LEF (n=77)MTX+APR(N=45)Median Age (years)373935Median disease duration (months)96101112Enthesitis (Ever)6(15%)21(27%)4(8%)Dactylitis (Ever)9((23%)28(36%)12 (26%)DAPSA < 46(15%)9(11%)10(22%) 4-1414(36%)25(32%)13(29%) 14-287(18%)24(31%)11(24%)PASI >107(18%) #14(18%) *1(2%) *#HAQ < 0.530(77%)60(78%)37(82%)MDA 5 achieved16(41%)25(32%)19(42%)*P value < 0.009 #P value <0.02Disclosure of Interests:None declared
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Fazaa, A., H. Boussaa, K. Ouenniche, S. Miladi, M. Sellami, L. Souabni, S. Kassab, S. Chekili, K. Ben Abdelghani, and A. Laatar. "POS0634 DO BIOLOGICS IMPROVE FATIGUE IN PATIENTS WITH RHEUMATOID ARTHRITIS?" Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 555.1–555. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3351.
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Background:Fatigue is a significant issue in rheumatoid arthritis (RA) with no accepted evidence-based management guidelines. Several studies suggested that biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have a direct role on fatigue in RA.Objectives:This study aimed to compare fatigue between patients treated with bDMARDs and conventional synthetic Disease Modifying Anti-Rheumatic Drugs (cs DMARDs).Methods:We conducted a longitudinal study including patients with RA (ACR/EULAR 2010). Patients with other acute or chronic diseases that may induce fatigue (such as cancer, infection or depression) were excluded. Demographic data and the following disease-related parameters were collected: pain Visual Analog Scale (VAS), Global Patient Assessment (GPA), tender joint count (TJC), swollen joint count (SJC), Erythrocyte Sedimentation Rate (ESR), C Protein Reactive (CRP), Disease Activity Score 28 (DAS28), Health Assessment Questionnaire (HAQ) and DMARDs used. Fatigue was assessed at baseline (T0), at 6 months (T6) and at 12months (T12) using the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) which is a short 13-item questionnaire validated in RA. The score FACIT-F ranges between 0 and 52. Fatigue was considered mild if the FACIT-F score was ≥40, moderate if 20≤FACIT-F<40 and severe if 0≤FACIT-F<20. A p value inferior to 0.05 was considered significant.Results:We included 100 RA patients (84 women and 16 men) with a mean age of 49.5±10 years old [18-65]. The mean disease duration was 87.3 months [1-360]. The mean pain VAS was 49 cm [0-100] and the mean GPA was 47.8 cm [0-100]. The mean TJC and SJC were 5.3 [0-36] and 1 [0-9] respectively. The mean levels of ESR and CRP were 38.1 mm [10-120] and 10.8 mg/l [2-61] respectively. The mean DAS28 ESR was 3.68 [1.90-8.33] and the mean HAQ score was 0.90 [0-2.75].Eighty-three percent of patients used csDMARDs: Methotrexate (n=96), sulphasalazine (n=28), leflunomide (n=21), and hydroxychloroquine (n=12). bDMARDs were prescribed in 17% of patients: Rituximab (n=10), Infliximab (n=9), and Etanercept (n=5).At baseline, the mean FACIT-F score was 27.1 [0-51]. Moderate fatigue was noted in 57% of cases and severe fatigue in 26% of cases. Patients on csDMARDs had a lower FACIT-F score when compared to patients on bDMARDs (26.89 versus 28.41), but the difference was not statistically significant (p=0.630).The mean FACIT-F score was 27.41 in bDMARDs patients versus 29.80 in csDMARDs patients (p=0.497) at T6, and 32.35 versus 33.65 respectively at T12 (p=0.695).The mean delta FACIT-F was 2.18 in bDMARDs patiens versus 2.73 in csDMARDs patients between T6 and T0 (p=0.815), and 3.94 versus 7.2 respectively between T12 and T0 (p=0.807).When considering all patients, a significant positive correlation was noted between delta FACIT-F and delta DAS28 at T6 (r=0.418, p<0.001) and at T12 (r=0.338, p<0.001).Conclusion:RA patients treated with bDMARDs didn’t show significant improvement of fatigue in comparison with those treated with csDMARDs. Further studies are needed to determine if biologics improve fatigue, and whether the improvement results from a direct action on fatigue or indirectly through reduction in disease activity.Disclosure of Interests:None declared
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Yardimci, G. K., B. Farisoğullari, B. Armagan, E. Bilgin, E. C. Bolek, E. Duran, L. Kiliç, et al. "SAT0443 CONCOMITANT PSORIATIC ARTHRITIS AND INFLAMMATORY BOWEL DISEASE IN THE PSA BIOLOGICAL REGISTRY: HUR-BIO REAL LIFE RESULTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1178–79. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6135.
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Background:Patients with spondyloarthritis (SpA) have 3 important extra-articular involvement; psoriasis, uveitis and inflammatory bowel disease (IBD). Psoriatic arthritis (PsA) patients may have IBD, as well, and clinical features of PsA + IBD patients do not assess comprehensively, yet.Objectives:The purpose of this study is to determine the frequency and clinical features of concomitant PSA and IBD in a PsA biological DMARD cohort.Methods:Hacettepe University Rheumatology Biologic (HUR-BIO) is a single center biologic registry since 2005 and include 469 psoriatic arthritis patients to date. Demographics, clinical features, co-morbidities, laboratory and disease activity parameters collected from the database. The diagnosis of IBD was accepted with colonoscopy findings and pathology.Results:Overall, 469 PsA patients (70% females) with the mean age 47.7±12.4 years and [median (IQR)] disease duration 7 (3-11) years included in the study. Overall, 10/469 (5 male) PsA patients (2.1%) had IBD (7 (70%) with ulcerative colitis and 3 (30%) Crohn’s disease). Mean age of the patients was 53.3±10.0 years and mean disease duration was 9.0 ± 6.1 years. Six of ten patients were diagnosed with IBD before PsA and 4 of them were diagnosed with PsA first. Patients were followed-up for 3.7±2.8 years and bDMARD switch were made in 4 patients mostly due to primary inefficacy. bDMARD was discontinued in 2 patients (one for Crohn disease with fistula and one for drug induced SLE). According to DAPSA score 44% of the patients had low disease activity and 56% of the patients had moderate disease activity at last visit (9 patients were available). Sacroiliitis (70%) and severe radiographic hip (20%) involvement were common in PsA patients with IBD. Disease characteristics and demographic data are given in table 1.Table 1.Disease characteristics and demographic data of PsA patients with IBDAge (years) /sexDisease duration (years)IBD typeSacroiliitisLast visit treatments61/M16Crohn’s disease(+)Azathioprine, GC50/M5Ulcerative colitis(+), hipAdalimumab, GC59/F3Ulcerative colitis(+)Certolizumab, methotrexate40/F10Ulcerative colitis-Adalimumab, methotrexate71/M19Ulcerative colitis-Infliximab62/M13Crohn’s disease(+), hipAzathioprine, GC, sulphasalazine50/F1Ulcerative colitis-Adalimumab, GC59/M12Crohn’s disease(+)Secukinumab, GC45/F9Ulcerative colitis(+)Adalimumab, methotrexate, GC36/F5Ulcerative colitis(+)Infliximab, methotrexate, GCConclusion:In our single center biological registry, relatively small portion of PsA patients had concomitant IBD, however, those cases may have severe axial involvement, particularly in hip involvement, and further studies needed for these subgroup. Physician should be aware those SpA subgroup, because treatment choices, particularly IL-17 inhibitors may have some cautions patients with PsA and IBD.Disclosure of Interests:Gözde Kübra Yardimci: None declared, Bayram Farisoğullari: None declared, Berkan Armagan: None declared, Emre Bilgin: None declared, Ertugrul Cagri Bolek: None declared, Emine Duran: None declared, Levent Kiliç: None declared, Omer Karadag: None declared, Ali Akdoğan: None declared, Şule Apraş Bilgen: None declared, Ali İhsan Ertenli: None declared, Sedat Kiraz: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB
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Duarte-Salles, T., M. Recalde, J. Weaver, E. Burn, K. Marinier, Y. Díaz, B. Illingens, et al. "SAT0134 COMPARATIVE RISK OF CANCER ASSOCIATED WITH FIRST-LINE DMARDS USE IN RHEUMATOID ARTHRITIS: REAL WORLD EVIDENCE FROM THE OHDSI NETWORK." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1004.1–1004. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3866.
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Background:Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are recommended as first line treatment for rheumatoid arthritis (RA) patients, but limited information exists on the comparative risk of cancer associated with their use.Objectives:To compare the risk of incident overall (excluding non-melanoma skin) and site-specific cancers (colorectal, lung, lymphoma, leukaemia) associated with first-line use of csDMARDs in patients with RA.Methods:We conducted a multinational cohort study informed by data from 7 healthcare databases including claims and electronic medical records from 4 countries (SIDIAP-Spain, MDCR-US Optum-US, CCAE-US, IQVIA AMBEMR-US, IQVIA-Germany, THIN-UK) part of the Observational Health Data Sciences and Informatics (OHDSI) network. All patients aged ≥18 years who initiated methotrexate (MTX), hydroxychloroquine (HCQ), sulphasalazine (SSZ), or leflunomide (LEF) as first-line monotherapy after a diagnosis of RA between 2005 to 2018 were eligible. Individuals with a prior diagnosis of another inflammatory arthropathy or cancer, or <1 year of follow-up were excluded. Patients were followed from 1-year after treatment initiation to the earliest of incident cancer, loss to follow-up, or 5-years. Cox proportional-hazard models for MTX against each other csDMARD were performed after propensity score stratification. A large set of negative control outcomes were analysed to calibrate hazard ratios (cHRs). Estimates were pooled where homogeneity across sources was adequate (I2<0.4).Results:Across the databases, 127,547 RA patients initiating csDMARD therapy were included in the analyses (MTX: 73,996, HCL: 36,381 SSZ: 9,383 LEF: 7,787). The pooled incidence rate of overall cancer for MTX was 22.8 per 1,000 person years. The pooled summary and source-specific estimated cHRs for overall cancer are shown below in Figure 1. While little difference was seen for HCQ and SSZ compared to MTX, LEF was consistently associated with a reduced cancer risk: pooled cHR (95% CI) 0.67 (0.59 to 0.76) and cHRs ranged from 0.53 (0.36 to 0.80) in CCAE-US to 0.84 (0.58 to 1.22) in SIDIAP-Spain. There were insufficient cases to look site-specific cancers within data sources, although pooled results suggest little risk difference in leukemia, lymphoma, colorectal, or lung cancers.Figure 1.Calibrated hazard ratios (cHRs) of overall cancer risk with their respective confidence intervals (95%CI) by study database. Database estimates not reported where adequate covariate balance not attained. Meta-analysis results not reported where I2>0.4.Conclusion:Compared to MTX users, patients treated with LEF had a lower risk of overall cancer. Risk of four specific cancers did not differ by first line csDMARD exposure.Disclosure of Interests: :Talita Duarte-Salles: None declared, Martina Recalde: None declared, James Weaver Shareholder of: J&J Shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Edward Burn: None declared, Karine Marinier Employee of: Servier, Yesika Díaz: None declared, Ben Illingens: None declared, David Vizcaya Employee of: Bayer, Katerina Chatzidionysiou Consultant of: AbbVie, Pfizer, Lilly., Patrick Ryan: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen
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Yardimci, G. K., B. Farisoğullari, E. C. Bolek, E. Bilgin, E. Duran, G. Ayan, Z. Özsoy, et al. "POS0633 DURATION OF STARTING bDMARDs ARE ALMOST 3 TIMES LONGER IN RA PATIENTS THAN PsA PATIENTS: HUR-BIO REAL LIFE RESULTS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 554.2–555. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3283.
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Background:Before using biological DMARDs, EULAR suggests the use of synthetic DMARDs (especially methotrexate) for RA and PsA [1-2].Objectives:It was aimed to evaluate the differences of disease duration and csDMARDs till first bDMARD in RA and PsA patients.Methods:HUR-BIO (Hacettepe University Biologic Registry) is a prospective, single center database of biological treatments since 2005 and to date 2070 RA and 520 PsA patients have been recorded. Demographic, clinical and laboratory data before bDMARDs of the patients were noted. When investigating the differences between groups, the effects of gender, age and disease duration wereadjusted using two-way ANOVA and ANCOVA tests. The selection was made for the gender, age and for indifference of the relevant groups by using prospensity score matching.Results:We incuded 481 RA, and 482 PsA age and gender matched patients in the study. Age, gender and disease duration information were given in the Table 1. 72.8% of the RA patients were RF or anti-CCP positive. Overall, 56.3, 100% of the RA, and PsA patients first biologic therapies were anti-TNFs, respectively. All RA patients started with csDMARDs before bDMARD treatments, whereas 450 of 482 (93.4%) PsA patients. Methotrexate was the anchor csDMARD for both diseases. RA patients more frequently used all csDMARDs included methotrexate, leflunomide, sulphasalazine hydroxychloroquine and corticosteroids as well. Median disease duration till bDMARD treatments in RA and PsA patients were 55 and 18.5 months respectively (p<0.001) (Table 1).Table 1.emographic characteristics and csDMARDs before first bDMARDRA (n=481)PsA (n=482)P valueFemale, n (%)319 (66.3)332 (68.9)0.218Age, years (mean±SD)48.2 ± 13.547.4 ± 12.20.332Disease duration, years*10 (6-16)7 (3-12)0.000Symptom duration before diagnosis, years¥0 (0-1)1 (0-4)0.000*The period of time between diagnosis and bDMARD initiation, months¥55 (24-115)18.5 (8-58)0.000*The period of time between symptoms and bDMARD initiation, months¥70 (35-151)48 (20-124)0.000*MethotrexateEver n (%)400 (83.3)373 (77.5)0.015Just before bDMARD initiation n (%)251 (52.2)230 (47.7)0.093Hydroxychloroquine sulfateEver n (%)292 (60.8)170 (35.3)0.000*Just before bDMARD initiation n (%)262 (54.5)99 (20.5)0.000*LeflunomideEver n (%)237 (49.4)129 (26.8)0.000*Just before bDMARD initiation n (%)160 (33.3)96 (19.9)0.000*SulphasalazineEver n (%)353 (73.5)265 (55.1)0.000*Just before bDMARD initiation n (%)156 (32.4)146 (30.3)0.259*CorticosteroidsEver n (%)419 (87.3)281 (58.4)0.000*Just before bDMARD initiation n (%)335 (69.6)187 (38.8)0.000*¥Median (IQR)Conclusion:According to HUR-BIO real life data, for inflammatory arthritis patients who started bDMARDs, the periods of time between diagnosis and bDMARDs were more reasonable (18 months) in PsA patients than RA patient’s periods which were approximately three times longer. RA patients were used much more and longer duration of csDMARDs. This explicit distinction may be explained by synthetic DMARDs on activity differences between the RA and PsA.References:[1]Gossec, L., et al., EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis, 2020. 79(6): p. 700-712.[2]Smolen, J.S., et al., EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis, 2020. 79(6): p. 685-699.Disclosure of Interests:None declared
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Ebrahim, Hasnaa Ali, and Dalia Mahmoud Abdelmonem Elsherbini. "Renovation of Intestinal Barrier by Polydatin in Experimentally Induced Ulcerative Colitis: Comparative Ultrastructural Study with L-Carnosine." Cells Tissues Organs, August 30, 2021, 1–18. http://dx.doi.org/10.1159/000516191.
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Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with intestinal epithelial barrier impairment. Polydatin (PD), a natural product isolated from <i>Polygonum cuspidatum</i>, is known to have an anti-inflammatory, antioxidant, and antiapoptotic effect. We attempted to compare the protective impact of PD pretreatment on alterations to the intestinal epithelial barrier and the colonic wall’s ultrastructure accompanying ulcerative colitis to other conventional drugs in practice, primarily L-carnosine, which has not been addressed before. The rats were divided into 5 groups; 3 of them were treated with sulphasalazine (500 mg/kg), L-carnosine (30 mg/kg), and PD (45 mg/kg). All groups were administered their respective drugs 3 days before the UC was induced by acetic acid intra-rectally, and the treatment was continued until the 11th day. The disease activity index (DAI) was estimated, and a macroscopic scoring was established for the harvested colonic tissue. The tissues were extracted and processed for hematoxylin and eosin staining, caspase-3 immunohistochemical staining, electron microscopy, and biochemical analysis evaluating proinflammatory markers (IL-1β, TNF-α, and IL-6), myeloperoxidase (MPO), oxidative stress, and lipid peroxidation. Histopathological examination of colonic tissue showed that PD pretreatment effectively restored mucosal epithelial cells, intercellular tight junctions, goblet cells, and maintained the intestinal epithelial and endothelial barriers. PD suppressed MPO, proinflammatory markers, and malondialdehyde but enhanced superoxide dismutase and glutathione levels. It also hampered apoptosis, as evidenced by a reduction in caspase-3 expression. PD showed a significantly better response in preserving the intestinal epithelial barrier against acetic acid-induced colitis as compared to sulphasalazine and L-carnosine. These findings demonstrate the therapeutic role of PD for patients with UC.