Journal articles: 'Biological therapy (BT)'

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Ibarguengoitia, O., I. Calvo, D. Montero, L. Vega, C. García, O. Fernandez, I. Torre, et al. "AB0151 FOLLOW-UP IN A MULTIDISCIPLINARY UNIT IMPROVES PREGNANCY OUTCOME IN INFLAMMATORY ARTHROPATIES ON BIOLOGICAL THERAPY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1103.2–1103. http://dx.doi.org/10.1136/annrheumdis-2021-eular.715.

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Background:Women with inflammatory arthropaties have fertility problems and complications during pregnancy and frequently biological therapy (BT) is required for the disease control.Objectives:To evaluate pregnancy in women with inflammatory arthropaties in a multidisciplinary unit composed of Rheumatologists and Obstetricians: describe disease evolution, complications and treatment used (including BT).Methods:Retrospective and descriptive study of the evolution of pregnancy in patients withinflammatory diseases (Rheumatoid Arthritis (RA), Spondyloarthritis (SpA) and Juvenile Idiopathic Arthritis (JIA)) and follow-up in a multidisciplinary unit for more than 15 years (until December 2020). Demographics, maternal disease, time until conception, previous abortions and presence of antibodies were collected. In addition, during follow-up, treatment, abortions, Caesarean sections (C-section), preterm births, disease activity and maternal/fetal complications were collected.Results:We registered 41 pregnancies (32 women): 20 RA (62.5%), 9 SpA (28.1%) and 3 JIA (9.4%). Maternal average age at diagnosis was 27.1±6.6 years and average age at childbirth/abortion was 34.9±5.1 years.It took an average time of 9.6±8.5 months to conceive. 9.8% received fertility treatment with in vitro fertilization techniques.AntiRo antibodies were registered in 7.3% of patients and 34.1% had at least 1 antiphospholipid antibody.At the time of gestational desire/gestation 17 women (12 RA, 4 SpA, 2 JIA) were receiving BT: 7 certolizumab (CZP), 7 adalimumab (ADA), 3 etanercept (ETN). 1 patient was being treated with baricitinib. Due to pregnancy, ADA was changed to CZP in 3 women and BT was stopped in 6 cases (3 ETN, 2 ADA, 1 CZP) as well as baricitinib. In 2 cases, ADA was stopped at week 17 of pregnancy (medical indication). Pregnancy was completed with BT (CZP) in 9 cases.9 abortions were registered prior to follow-up in the unit (0.28 abortions/mother) and 3 during follow-up (0.09 abortions/mother): 2 of them in women with CZP.C-section was performed in 26.8% of cases.Preterm birth (<37 weeks) happened in 9.7% (n: 4) of the pregnancies: 1 case in a woman with CZP.A total of 17 different fetal/maternal complications were registered during follow-up: 6 in the BT group (35.3%) compared to 11 (64.7%) in the group without BT, being Intrauterine Growth Restriction (IUGR) more frequent among women with BT. Infections were not more common in patients with BT. Complications are listed in Table 1.Table 1.COMPLICATIONSWITH BT (n, %) n: 11WITHOUT BT (n, %) n: 30IUGR3 (27.3%)1 (3.3%)LOW BIRTH WEIGHT2 (18.2%)2 (6.6%)INFECTION1 (9.1%)4 (13.3%)CHOLESTASIS0 (0%)2 (6.6%)PREECLAMPSIA0 (0%)1 (3.3%)DIABETES MELLITUS0 (0%)1 (3.3%)HIGH BLOOD PRESSURE0 (0%)0 (0%)NEPHROPATY0 (0%)0 (0%)NEONATAL LUPUS0 (0%)0 (0%)HEART BLOCK (0%)0 (0%)MALFORMATION0 (0%)0 (0%)HELLP SYNDROME0/0%)0 (0%)TOTAL6 (54.6%)11 (36.4%)Regarding concomitant treatment, low dose prednisone was used in 48.8% of pregnancies, hydroxychloroquine in 51.2%, sulfasalazine in 9.8% and acetylsalicylic acid in 51.2%. We didn´t find differences in the use of these treatments between the two groups.Median DAS28 among RA patients and available data was under 2.6 throughout pregnancy as well as previously and posteriorly. No differences in median DAS28 were found between women with BT and without BT. SpA patients had BASDAI lower than 4 in both groups during pregnancy and previously.Conclusion:In our series, as described in the literature, women with inflammatory arthropaties are older and are more likely to have preterm births compared to general population. Fewer abortions were registered during follow-up in the multidisciplinary unit. Appropriate disease control was maintained during pregnancy, also previously and afterwards. We registered more IUGR and low birth weight among women with BT but given the low number of patients with BT no statistically significant conclusions about complications can be drawn. Therefore, more studies among pregnant women with BT are necessary.Disclosure of Interests:None declared

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Vega, L., I. Calvo, O. Ibarguengoitia, D. Montero, C. García, E. Galindez, J. M. Blanco, et al. "AB0170 RHEUMATOID ARTHRITIS ASSOCIATED LUNG DISEASE: EXPERIENCE IN A BIOLOGICAL THERAPY UNIT." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1111.2–1112. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3178.

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Background:Rheumatoid arthritis (RA) associated lung disease is a relatively frequent extra articular disease manifestation, with a prevalence between 5% and 30%. The rather wide range of estimated prevalence is a result of differences in study designs and studied populations, as well as lacking diagnostic and classification criteria for lung disease in patients with RA.Objectives:To evaluate the prevalence of RA associated lung disease in patients with biological therapy (BT), as well as its severity, treatment changes and possible associated factors.Methods:Review of clinical records of 257 patients with RA treated with BT (TNFi, non-TNFi) between January 2015 to December 2020 in a single center. Patients with preexisting lung disease for other causes (asthma, smoking) have been excluded. RA diagnosis was performed according to ACR 2010 classification criteria. Epidemiological variables, clinical characteristics, type of pulmonary involvement, evolution, type of BT, changes in treatment and concomitant treatment were collected. For the analysis frequencies and percentages are used in qualitative variables, and mean ± SD in the quantitative ones. Statistical analysis was performed with IBM SPSS v 23.Results:We registered 21 patients (85.7% women) mean aged 70.3±11.9 years. 52.4% were never smokers. RF was positive in 100% and 20 patients were anti-CCP positive. Erosive disease was present in 13 (61.9%) patients.At the time of lung disease diagnosis, 15 patients (66.7%) were receiving TNFi (Etanercept 7, Adalimumab 6, Infliximab 1, Golimumab 1), 2 were with non-TNFi (Rituximab) and 4 had never received BT previously. Symptoms (cough and/or dyspnea) were reported in 10 (47.6%) patients. The median time of treatment with BT until lung disease diagnosis was 33 [15.5-95.5] months. Conventional synthetic DMARDs (csDMARDs) were used in 85.7% of cases (methotrexate 72.2%, leflunomide 22.2%, other 5.6%). The inflammatory activity was mild (DAS28: 3.22±1.6). The median time until lung disease diagnosis was 104 [56.2-156] months.After the lung disease diagnosis, BT was only modified in 1 patient. In the 4 patients who had not previously received BT, non-TNFi was started (Rituximab 2, Abatacept 1, Tocilizumab 1). csDMARD was discontinued in 1 patient.Interstitial lung disease (ILD) was the most frequent pulmonary involvement (16 patients, 76.2%): 8 usual interstitial pneumonia (UIP), 6 non-specific interstitial pneumonia (NSIP), 1 organising pneumonia (OP) and 1 lymphocytic interstitial pneumonia (LIP). Other pulmonary manifestations observed in our patients were: nodular lung disease (2 patients) and small airways disease (bronchiectasis 2, obliterative bronchiolitis 1). Chest x-ray was normal in almost half of the patients (42.9%). Gold standard image diagnostic technique was high resolution CT.In respiratory function tests (PFTs) at diagnosis, only 4 patients (19%) had a FVC<80% and 4 (19%) a DLCO<60%. In the following 2 years, in 2 patients the FVC worsened > 10% and in 5 there was a worsening of the DLCO > 15%. In 3 (14.3%) patients PFTs were never performed and in 7 (43.7%) were not repeated after the diagnosis.We haven´t found association between different types of pulmonary involvement and the variables analysed.Conclusion:In our series, prevalence of RA associated lung disease is similar to that described in the literature. Lung involvement is asymptomatic and chest X-ray is normal in most RA patients. High resolution CT is the gold standard for diagnosis.ILD was the most frequent pulmonary involvement. Although in most patients the diagnosis of lung disease did not imply a BT change, it had an influence on the type of BT chosen for those who started treatment. Maintenance of csDMARD was not associated with a worsening of lung disease.Screening and treatment protocols for lung disease in patients with RA in clinical practice are needed.Disclosure of Interests:None declared

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Godoy-Navarrete, F., S. Manrique Arija, F. Osorio, A. M. Cabezas-Lucena, M. Morales-Águila, and F. G. Jiménez-Núñez. "AB1175 BIOLOGICAL THERAPY DOSE OPTIMIZATION AND COST MINIMIZATION STUDY IN SPONDYLOARTHRITIS: UTILITY OF REDOSER TOOL." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1878–79. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5658.

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Background:Objectives:. To describe the percentage of spondyloarthritis patients on biological therapy (BT) optimization in clinical practice whowould maintain remission or low disease activity (LDA) after 2 years of follow-up and to identify possible factors associated with relapse. To estimate the cost reduction between 2009-19Methods:Design:A retrospective, observational longitudinal study under conditions of clinical practice.Patients:Spondyloarthritis in BT dose reduction. Inclusion criteria: Psoriatic arthritis (CASPAR criteria), and Axial Spondyloarthritis (ASAS criteria) which have been iniciated BT dose reduction between 2009-2019. Patients with BT are followed prospectively by two rheumatologists in a monographic clinic of subcutaneous biological therapy every 6 months, and with their usual rheumatologist every 6 months, as well. In such, the patients are controlled and attended in clinics with a pre-established questionnaire every 3 months.Variables:Maintained Reduction:patients who maintained BT dose reduction since de beginning of the optimization until the index date(data collection).Relapse at 3,6,12,24 months: patient who had to returnt to usual BT dose. Other variables: demographic, time to diagnosis and evolution disease, clinical-analytical: Tender Joint Count(TJC), Swollen Joint Count (SJC), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), activity index: DAPSA; BASDAI, ASDAS and physical function: HAQ and BASFI. Previous treatment with bDMARD. Dose reduction adjustment according to REDOSER. Cost reduction in euros(absolute and per patient-year) of BT in patients who are in dose reduction compared to the standard care. Analysis: Descriptive, Bivariate analysis, Multivariate logistic regression (DV:relapse). The absolute cost reduction and per patient-year was calculated.Results:65 patients with spondyloarthritis in dose reduction were included. Table 1 main characteristics in study population. The average time since the beginning of the BT was 47.61 months (±37.06). After 24 months of follow-up, 73.8% of patients (48) achieved a sustained reduction. All these patients accomplish remission or low disease according to differente index activities [DAPSA and BASDAI median(p25-p75)= 2.3 (2.1- 2.9) and 1.5 (0.7- 2.6), respectively and ASDAS mean (SD) =1.4 (0.54)] and a shorter time of disease evolution. The dose reduction of BT carried out from 2009 to 2019 meant a total cost savings of 584080.37€, with a patient/year cost savings of 6192.28€. We evaluated the optimization according to REDOSER and it was observed that in 53 patients (81.5%) the reduction would have been adequate and the rest was doubtful. In bivariant analysis between patients who had relapsed and those who had not, only differences were observed in the BT line used [2nd line:(5(29.4%) Vs 2(4.2%),(p=0.025)] and and a higher percentage of patients with a doubt result of REDOSER [9(52.9%)Vs 3(6.3%), p<0.001)] respectively. In multivariant analysis the only independent variable associated with relapse was a doutbful result of REDOSER[OR(IC95%), 3.46(1.18-10.17); p=0.024], R2= 40.2%Figure 1:Conclusion:Biological therapy dose reduction in spondyloarthritis is possible in the majority of patients, maintaining remission/LDA at 24 months. This leads to a greater cost reduction and efficiency. The relapse was associated with a doubtful result in REDOSER before optimization and this tool can be very useful in the assessment of BT reduction.Disclosure of Interests:None declared

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Michalak, Agata, Beata Kasztelan-Szczerbinska, Katarzyna Laskowska, Piotr Radwan, Marek Cybulski, and Halina Cichoż-Lach. "Efficacy of biological treatment in inflammatory bowel disease – a single-center experience." Polish Journal of Public Health 129, no. 3 (September 1, 2019): 105–9. http://dx.doi.org/10.2478/pjph-2019-0024.

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Abstract Introduction. Efficacy of biological treatment (BT) is a key issue among inflammatory bowel disease (IBD) patients. Laboratory markers and endoscopic procedures are basic diagnostic tools in the assessment of response to biological agents in the course of Crohn’s disease (CD) and ulcerative colitis (UC). Aim. The aim of our investigation was to assess the correlation between laboratory parameters and endoscopic picture in the course of BT in patients with IBD – CD and UC–treated with biological agents. Material and methods. The total number of 71 patients were enrolled in the study, 25 with CD and 46 with UC. When it comes to 15 patients with CD, they were treated with infliximab (IFX) and 10 patients with adalimumab (ADA) – one year of therapy. Patients with UC were administered IFX – induction therapy. Laboratory tests (C-reactive protein (CRP) and platelet (PLT) count) and colonoscopy were performed in all patients before and during BT. Results. BT improved endoscopic picture (SES-CD, MAYO) in all patients. BT lowered CRP (p<0.05) and PLT count (p<0.05) in CD group. CRP level and PLT count decreased in UC group, too (p<0.05). A positive correlation between PLT count and SESCD score prior to the first dose was noticed in ADA group. CRP level correlated positively with PLT count in CD patients treated with IFX before the introduction of BT. Moreover, CRP level correlated positively with both MAYO score and MAYO endoscopic subscore after the second dose of IFX and after finished induction regimen in UC group. Discussion. BT revolutionized a natural history of IBD and its efficacy was approved worldwide. Nevertheless, biological agents do not lead to a full remission of the disease in all patients. Because of this reason, laboratory parameters and endoscopic picture must be carefully monitored during BT to achieve the best outcome in IBD patients. Conclusion. Full clinical and endoscopic remission of IBD was not achieved, although BT lowered CRP level, PLT count and improved endoscopic picture of patients enrolled into our study.

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Cabezas-Lucena, A. M., M. Morales-Águila, S. Manrique Arija, C. Fuego-Varela, L. Cano Garcia, and N. Al Mashhadani. "AB1176 UTILITY OF REDOSER TOOL IN DOSE OPTIMIZATION OF BIOLOGICAL THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN CLINICAL PRACTICE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1879.2–1879. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5875.

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Background:Objectives:To describe the characteristics of patients with rheumatoid arthritis (RA) in dose reduction of biological therapy (BT) in clinical practice and identify possible factors associated with the time in dose reduction and verify the utility of REDOSER tool.Methods:Design:A retrospective, observational longitudinal study under conditions of clinical practice.Patients:RA in BT dose reduction between 2007- 2019 were selected. Inclusion criteria: RA according to ACR 2010 criteria which have been initiated BT dose reduction. Patients with BT are followed prospectively every 3-4 months in a specialized outpatient unit of BT dose reduction with a pre-established protocol for data collection and registered in a database.Variables: Primary:Time in reduction: was defined as the time in which patients maintained the BT optimization andRelapse at 12 and 24 months: percentage of patients who, after starting BT optimization, return to the previous or standard dose.Secondary variables:REDOSER:Appropriate, Doubtful and Inappropriate (If dose reduction was adequate according to the REDOSER tool applied retrospectively were evaluated). Other variables: Demographic, clinical-analytical: time of disease evolution, RF, anti CCP antibodies, Number of Tender Joints, Number of swollen joints, erosions, activity index (DAS28, SDAI, CDAI) and physical function (HAQ). Previous treatments.Statistical Analysis:descriptive, bivariate using x2 and T-Student among patients with and without relapse at 24 months and multivariate linear regression to identify independent variables associated with the time in BT dose reduction (DV: time in reduction).Results:59 patients with RA were included. Table 1 shows the main characteristics of the subjects. The average (SD) of optimization in months was 17.9 (17.7). Ten patients (16.9%) relapsed at 12 months and 16 (27.1%) at 24 months. The mean (SD) of DAS28 and SDAI of patients who relapsed at 24 months was higher compared to baseline DAS28 (2.3 [0.9] vs. 1.5 [0.8]; p = 0.015) and SDAI (7.8 [6.3] versus 3.3 [1.6]; p 0.05). These patients who relapsed at 24 months compared to patients who did not have more erosions at the start of BT (p = 0.004), longer duration of disease (p = 0.072) and greater baseline activity of DAS28 (p = 0.017), of SDAI (p = 0.030) and CDAI (p = 0.036). After simulating the REDOSER tool to all patients at the beginning of the OBT, 28 patients (56%) were “Appropriate”, 20 (40%) “Doubtful” and 2 (4%) “Inappropriate” of which they continue in OBT at the conclusion of study 22, 10 and 0, respectively (p = 0.020). In the multivariant analysis, the independent variables that are associated with time in dose reduction of BT were baseline DAS28 (β = -0.660, 95% CI[2.7-14.0]; p=0.014) and age (β=-0.800, 95% CI [0.8-0.0]; p=0.038).Conclusion:The majority of the patients with RA who initiate BT dose reduction maintain the optimization after 24 months. REDOSER can be useful in clinical practice to assess the BT optimization in patients with RA. A longer time in BT dose reduction was associated with lower values of DAS28 at the beginning and younger age of the patients.Figure 1:Disclosure of Interests:None declared

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Castro, P., and A. Onteniente. "AB1150 ECONOMIC IMPACT ASSOCIATED TO BIOLOGICAL THERAPY / SYNTHETIC FAME OPTIMIZATION IN A COHORT OF PATIENTS WITH CHRONIC INFLAMMATORY RHEUMATIC DISEASES TREATED BY OBJECTIVES." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1865.2–1866. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5354.

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Background:Therapeutic decision-making for biologic-therapies/ synthetic FAME (BT/SD) dose optimization, should be based on optimal disease activity results according to a treatment strategy by objectives. The goal of BT optimization is to guarantee long-term effectiveness and safety, maximising economic savingsObjectives:To evaluate BT optimization patterns in patients with rheumatic diseases (RD) and associated economic savings.Methods:An observational and prospective study, which included a cohort of patients with rheumatoid arthritis (RA), spondyloarthropathies (SA) and psoriatic arthritis (PsA) treated with BT from January 2014 to December 2019. BT optimization, achieved by reducing or prolonging the interval at least one dose, was indicated when patients have more than 6 months of treatment and are in clinical remission (DAS28 <2.6 for RA and PsA, and BASDAI<2 for SA) or minimal clinical activity (DAS28<3.2 for RA and PsA, and BASDAI<4 for SA).Variables were described as frequencies and means. Diagnosis, BT (abatacept, adalimumab, apremilast, baricitinib, certolizumab, etanercept, golimumab, ixekizumab, secukinumab, tocilizumab, tofacitinib, and ustekinumab), dose regimens, total treatment duration, time on BT optimization (TO) and treatment costs were collected.Cost savings were calculated per patient by comparing optimization treatment costs to conventional treatment and globally by comparing real cost to theoretical conventional doses cost.Results:A total of 260 patients were included in the study. Switching were observed in 32.7%. From all patients, 53% were candidates for BT optimization (according to diagnosis: 60.9% with RA, followed by 52.2% with SA and 43.4% with PsA)A 40% of patients with BT optimization were treated with adalimumab and etanercept being also the most common BT used in RD treatmentBT optimization allowed a pharmaceutical saving of€ 177,539.40per year against the use of conventional therapy, resulting in a reduction of the total cost of€1,065,236.40in the last 6 years. The saving per patient / year was € 707.63 for RA; € 850,40 for SA and of €493,21 for the PsA.Conclusion:Therapeutic decision-making based on validated disease activity scales has allowed the BT optimization in approximately 53% of patients with RD.BT optimization allowed a pharmaceutical saving of € 177,539.40 per year being higher in the SA (€ 850.40) followed by the RA (€ 707.63) and finally the PsA (€ 493.21)The BT optimization allows to reduce costs maintaining the effectiveness and safety.Disclosure of Interests:None declared

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Dressler, Dirk, Bruno Kopp, and Fereshte Adib Saberi. "Botulinum toxin dosing in arm muscles: contextual factors." Journal of Neural Transmission 128, no. 3 (January 30, 2021): 315–19. http://dx.doi.org/10.1007/s00702-021-02307-1.

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AbstractBotulinum toxin (BT) has been successfully used for many years to treat various muscle hyperactivity disorders including dystonia and spasticity. Its dosing is guided by dosing tables describing target muscles and dose ranges. To refine the BT dosing, we wanted to analyse how contextual factors may influence the injector's final dosing decision.In a retrospective review of real-life data of 1170 BT treatments, we studied the influence of various contextual factors on the BT doses in 21 arm muscles of 252 patients receiving BT therapy for different muscle hyperactivity disorders.We found that BT arm doses are significantly higher in treatment of spasticity than in treatment of dystonia. We also found that spontaneous arm dystonia requires higher BT doses in a proximal application pattern, whereas task specific writer's cramp requires considerably reduced BT doses with a distal application pattern. Injections of non-arm muscles influence the BT dosing in arm muscles only marginally.Our study demonstrates that BT dosing does not only depend on the particularities of the individual target muscle injected, such as its volume and its static or phasic function. BT dosing and its application pattern rather depend on additional contextual factors such as the aetiology and pathophysiology of the muscle hyperactivity treated. These contextual factors need to be included in dosing tables and may improve the outcome of BT therapy.

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Dressler, Dirk, Maria Concetta Altavista, Eckart Altenmueller, Roongroj Bhidayasiri, Saeed Bohlega, Pedro Chana, Tae Mo Chung, et al. "Consensus guidelines for botulinum toxin therapy: general algorithms and dosing tables for dystonia and spasticity." Journal of Neural Transmission 128, no. 3 (February 26, 2021): 321–35. http://dx.doi.org/10.1007/s00702-021-02312-4.

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AbstractBotulinum toxin (BT) therapy is a complex and highly individualised therapy defined by treatment algorithms and injection schemes describing its target muscles and their dosing. Various consensus guidelines have tried to standardise and to improve BT therapy. We wanted to update and improve consensus guidelines by: (1) Acknowledging recent advances of treatment algorithms. (2) Basing dosing tables on statistical analyses of real-life treatment data of 1831 BT injections in 36 different target muscles in 420 dystonia patients and 1593 BT injections in 31 different target muscles in 240 spasticity patients. (3) Providing more detailed dosing data including typical doses, dose variabilities, and dosing limits. (4) Including total doses and target muscle selections for typical clinical entities thus adapting dosing to different aetiologies and pathophysiologies. (5) In addition, providing a brief and concise review of the clinical entity treated together with general principles of its BT therapy. For this, we collaborated with IAB—Interdisciplinary Working Group for Movement Disorders which invited an international panel of experts for the support.

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Akulova, A. I., K. D. Dorogoikina, I. Z. Gaydukova, and A. P. Rebrov. "Quality of life in spondyloarthritis patients receiving biological therapy." Modern Rheumatology Journal 13, no. 4 (October 23, 2019): 36–40. http://dx.doi.org/10.14412/1996-7012-2019-4-36-40.

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Spondyloarthritides (SpAs) is a group of chronic inflammatory diseases of the spine, joints, and entheses characterized by common clinical, radiological, and genetic features. According to international guidelines, one of the main goals of SpA treatment is to ensure the longest possible preservation of the patient's quality of life (QOL). The use of biological agents (BAs) allows rapid clinical improvement and positively affects QOL in patients.Objective: to evaluate the efficacy of BAs on QOL in patients with SpA in real clinical practice.Patients and methods. A total of 280 patients with SpA were examined. The inclusion criteria were ≥18 years of age; compliance of the clinical picture of the disease with the ASAS criteria for axial SpA (2009) or peripheral SpA (2011); and signing the informed consent form. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI); ASAS HI was used to comprehensively evaluate the impact of SpA on the patient's health. The European QL EQ-5D-5L and the SF-36 questionnaire were applied to determine quality of life in the patients.Results and discussion. The patients' mean age was 40.19±11.9 years; there was a male preponderance (64%); the HLA-B7-pisitive patients were 78%. The median scores were 5.40 [3.12; 6.80] for BASDAI, 3.37 [2.58; 4.15] for ASDAS, 5.30 [2.60; 7.50] for BASFI, 4.00 [2.60; 6.15] for BASMI, and 9.00 [7.00; 12.00] for ASAS HI. Forty-four patients received a variety of BAs. Patients receiving and not receiving BAs were matched for age and gender; however, the patients on biological therapy (BT) had longer disease duration and lower disease activity according to the ASDAS. There were no statistically significantly difference between the two groups in disease activity according to the BASDAI and in functional disorders according to the BASFI; but there was a tendency towards lower values in the patients on BT. Comparison of QOL in the patients of the two groups revealed statistically significant differences in SF-36 pain scale scores (p=0.02) and EQ-5D-5L indicators (p<0.01).Conclusion. BT makes it possible to successfully achieve one of the main goals of treating patients with SpA, namely to preserve QOL. The patients receiving BAs had longer disease duration, while they were comparable to those not receiving this treatment in terms of the degree of functional disorders.

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Herrero-Morant, A., I. González-Mazón, V. Calvo-Río, J. Rueda-Gotor, M. Á. González-Gay, and R. Blanco. "POS0934 BIOLOGICAL THERAPY IN UVEITIS ASOCIATED TO AXIAL SPONDYLOARTHRITIS. SINGLE CENTER UNIVERSITY STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 730.2–731. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3229.

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Background:Uveitis is the most frequent extraarticular manifestation of axial Spondyloarthritis (axSpA). Effects of Biological Therapy (BT) on uveitis associated to axSpA are contradictory (1-3).Objectives:To assess in uveitis associated to axSpA a) frequency and features of uveitis, and b) efficacy and relation of BT in a single-center university study.Methods:Observational study from a cohort of 301 consecutive unselected patients with axSpA classified according to the Assessment of SpondyloArthritis International Society criteria. Episodes of uveitis were analyzed before and after BT initiation. Likewise, uveitis incidence rate (episodes/100 patients/year) at baseline and after first BT was calculated.Results:Uveitis was observed in 44 (25 men/19 women) out of 301 (14.6%) patients. Mean age was 45.6 ± 10.3 years. Demographic and clinical features in patients who developed uveitis and those that did not are summarized in Table 1. After 18.6 ± 10.4 years of follow-up, 44 (14.6%) patients suffered from at least one episode of uveitis. Uveitis was anterior and acute in all cases and unilateral in 37 (84.1%) patients. Mean anterior chamber cells was 1.7 ± 1.2 cells.Per episode of uveitis, 20 patients received BT with: secukinumab (SECU) (n=7, 35%), adalimumab (n=6, 30%), golimumab (n=3, 15%), infliximab (n=2, 10%), certolizumab (n=1, 5%), and etarnecept (ETN) (n=1, 5%). Before the initiation of BT, patients treated with SECU developed 29.7 episodes/100 patients/year while those treated with monoclonal anti-TNFα 16.3 episodes/100 patients/year and patients with ETN 5.8 episodes/100 patients/year. After 5.9 ± 3.7 years of follow-up, patients treated with SECU developed 16.1 episodes/100 patients/year while those treated with monoclonal anti-TNFα 7.6 episodes/100 patients/year and patients with ETN 0 episodes/100 patients/year (Figure 1). No serious adverse effects were observed.Conclusion:Uveitis was observed in 14.6% of axSpA. Most of them were HLA-B27 positive. Acute, anterior and unilateral was the most frequent pattern of uveitis in axSpA. There was a similar decrease in incidence rate between patients treated with SECU and those treated with monoclonal anti-TNFα.References:[1]Deodhar AA, et al. ACR Open Rheumatol. 2020; 2:294-299.[2]Roche D, et al [abstract]. Arthritis Rheumatol 2019; 71 (suppl 10).[3]Lindström U, et al Annals of the Rheumatic Diseases 2020;79:9-10.Table 1.Main general features and differences between patients with and without uveitis.Overalln= 301Uveitisn= 44Non uveitisn= 257pAge, years (mean±SD)44.9 ± 11.845.6 ± 10.344.8 ± 12.10.47Gender, n (m/w) (%)179/122 (59.5/40.5)25/19 (56.8/43.2)154/103 (59.9/40.1)0.71HLAB27 positive,n (%)190 (63.1)37 (84.1)153 (60.0)0.00Follow-up of axSpA, year (mean±SD)13.5 ± 11.218.6 ± 10.512.6 ± 11.10.33Family history, n (%)84 (27.9)15 (34.1)69 (27.2)0.35r-axSpA, n (%)217 (72.1)36 (81.8)181 (70.4)0.12nr-axSpA, n (%)84 (27.9)8 (18.2)76 (29.6)0.12Enthesitis, n (%)108 (35.9)14 (31.8)94 (36.6)0.54Peripheral arthritis, n (%)96 (31.9)12 (27.3)84 (32.7)0.47Psoriasis, n (%)35 (11.6)6 (13.6)29 (11.3)0.65Inflammatory bowel disease, n (%)22 (7.3)2 (4.5)20 (7.8)0.45Hip involvement, n (%)20 (6.6)3 (6.8)17 (6.6)0.96Dactylitis, n (%)17 (5.7)3 (6.8)14 (5.4)0.72Cardiovascular event, n (%)7 (2.3)1 (2.3)6 (2.3)0.98Figure 1.Uveitis incidence rate before and after biological therapy.Disclosure of Interests:Alba Herrero-Morant: None declared, Iñigo González-Mazón: None declared, Vanesa Calvo-Río Speakers bureau: Abbott, Lilly, Celgene, Grünenthal, UCB Pharma, Grant/research support from: MSD and Roche, Javier Rueda-Gotor: None declared, Miguel Á. González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Sanofi, Lilly and MSD, Grant/research support from: AbbVie, MSD and Roche

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Cardoso, Eduardo, Glícia Pedreira, Antônio Prazeres, Nildo Ribeiro, and Ailton Melo. "Does botulinum toxin improve the function of the patient with spasticity after stroke?" Arquivos de Neuro-Psiquiatria 65, no. 3a (September 2007): 592–95. http://dx.doi.org/10.1590/s0004-282x2007000400008.

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Post-stroke spasticity is an important cause of disability in adults, due to muscle hyperactivity, which results in limb stiffness and muscle spasm. The prognosis for these patients depends on several features such as early management and adequate physical therapy to avoid muscle shortening, pain, and their consequences. Although several papers have shown that intramuscular injections of botulinum toxin type A (BT-A) decreases spasticity in post-stroke patients, few authors have demonstrated functional improvement after this therapy. In order to assess if individualized BT-A injections improves upper limb function in post-stroke spastic patients, we prospectively followed 20 consecutive patients of 18 years of age or more with spastic hemiparesis secondary to stroke. Fulg-Meyer scale modified for upper limbs, measure of functional independence (MFI), Ashworth modified scale, and goniometry were applied in the beginning of the investigation and in the 16th and 32nd weeks. BT-A was applied at baseline and in the 16th week. All subjects were submitted to rehabilitation therapy. All patients showed improvement according to Ashworth modified scale and increase in the range of motion, which were sustained until the 32nd week (p<0.05). The assessment of the first three parameters of the Fulg-Meyer scale and the evaluations of the motor part of the Functional Independence Measure showed statistically improvement until the end of the study. We conclude that proper choice of muscles and individualized doses of BT-A can improve function in selected post-stroke patients.

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Loeb, Luana Mazzacoratti, Rebeca Padrão Amorim, Maria da Graça Naffah Mazzacoratti, Fulvio Alexandre Scorza, and Mario Fernando Prieto Peres. "Botulinum toxin A (BT-A) versus low-level laser therapy (LLLT) in chronic migraine treatment: a comparison." Arquivos de Neuro-Psiquiatria 76, no. 10 (October 2018): 663–67. http://dx.doi.org/10.1590/0004-282x20180109.

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ABSTRACT The aim of this work was to evaluate patients with chronic migraine treated with botulinum toxin A (BT-A) and compare this with low level laser therapy (LLLT), referencing: pain days, pain intensity, intake of drugs/self-medication, anxiety and sleep disorders. Methods: Patients were randomized into two groups: BT-A group (n = 18) and LLLT group (n = 18). Each patient kept three pain diaries: one before (baseline) (30 days), one during treatment (30 days) and one after the post-treatment phase (30 days). Repeated ANOVA plus the Bonferroni post-test, Student's t test, and factorial analysis were applied, and p < 0.05 was accepted as significant. Results: Our data showed that both treatments were able to reduce headache days, acute medication intake and decrease the intensity of pain. Anxiety was reduced in the BT-A group, while sleep disturbance was reduced in the LLLT group. Conclusion: Our data showed that both treatments can be used to treat chronic migraine, without notable differences between them.

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Mena-Vazquez, N., S. Manrique Arija, M. C. Ordόñez Cañizares, M. Rojas Giménez, C. Domic Bueno, C. Fuego Varela, I. Ureña Garnica, et al. "AB0367 Adherence To The Biological Therapy (BT) in Patients with Rheumatoid Arthritis (RA):." Annals of the Rheumatic Diseases 75, Suppl 2 (June 2016): 1029.1–1029. http://dx.doi.org/10.1136/annrheumdis-2016-eular.2838.

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García Fernández, A., A. Briones-Figueroa, L. Calvo Sanz, Á. Andreu-Suárez, J. Bachiller-Corral, and A. Boteanu. "SAT0501 EARLY START OF BIOLOGICAL TREATMENT IN JUVENILE IDIOPHATIC ARTHRITIS: DOES A THERAPEUTIC WINDOW EXIST IN REAL LIFE?" Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1207.2–1207. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4611.

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Background:Biological therapy (BT) has changed the treatment and perspectives of JIA patients but little is known about when is the best moment to start BT and the impact of this prompt iniciation.Objectives:To analyze the response to BT of Juvenile Idiophatic Arthritis (JIA) patients according to the time when the BT was started.Methods:A retrospective, descriptive study was conducted on JIA patients followed up in a referal hospital that started BT up to 24 months after diagnosis from 2000 to 2018. Disease activity was measured, at 2 years after diagnosis, according to Wallace criteria for remission (absence of: active arthritis, active uveitis, fever, rash or any other manifestation attributable to JIA, normal CRP and ESR, PGA indicating no active disease) for at least 6 months.Results:55 JIA patients that started BT up to 24 months from diagnosis were analyzed. 69,1% were girls with a median age at diagnosis of 8 years old IQR(3-13), median age at the start of BT of 9 years old IQR(3-13). Regarding JIA categories: 25,5% were Oligoarticular Persistent (OligP), 18,2% Systemic JIA (sJIA), 16,4% Entesitis related Arthritis (ERA), 12,7% Psoriatic Arthritis (APso) and Polyarticular RF- (PolyRF-), 5,5% Oligoarticular Extended (OligE) and Polyarticular RF+ (PolyRF+), 3,6% Undifferentiated (Und). 20% of patients had uveitis during followup. Conventional DMARD (cDMARD) was indicated in 83,6% of patients (95,7% Methotrexate) at diagnosis [median 0 months IQR(0-2,3)]. At the end of followup (2 years) only 30,9% of patients continued with cDMARDs. The main causes of discontinuation were: adverse events (46,7%), remission (36,7%). TNF inhibitors were precribed in 81,8% of patients and 18,2% of patients recieved two BT during the first 2 years from diagnosis. 54,5% of BT were indicated during the first 6 months from diagnosis, 27,3% from 7 to 12 months, 12,7% from 13 to 18 months, 5,5% from 19 to 24 months.After 2 years from diagnosis, 78,2% of patients were on remission and 21,8% active. Among patients with active disease: 75% had arthritis, 16,7% had uveitis and 8,3% had both. There were no differences regarding disease activity among patients with uveitis and neither taking cDMARDs. Regarding JIA categories: 66,7% of OligE, 57,1% of PolyRF- and 57,1% of APso patients were active at 2 years from diagnosis when compared to the other categories (p=0.004).Patients on remission at 24 months from diagnosis started sooner the BT than active patients [CI 95% (0,46-8,29) p=0,029]. The time when the BT was started was correlated to the activity at 2 years (K= 0,294 p=0,029). When the BT was prescribed after 7,5months from diagnosis it was correlated, in a COR curve, with a higher probability of active disease at 2 years (S= 0,67 E= 0,63). There was a correlation, among patients on remission at 2 years, between prompt start of BT and less time to reach remission (K= -0,345 p=0,024). Patients with active disease at 2 years, regardless of moment of BT iniciation, required more BT during follow-up (p=0,002).Conclusion:Prompt iniciation of BT was correlated with a better outcome. JIA patients that started BT early after diagnosis had a higher probability of remission after 2 years. Starting BT after 7,5 months was correlated with a higher probability of active disease at 2 years. Active disease at 24 months was correlated with persistent active disease during follow-up.Disclosure of Interests:None declared

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Manrique Arija, S., A. M. Cabezas-Lucena, F. Godoy-Navarrete, M. Morales-Águila, R. Redondo, and N. Mena-Vázquez. "AB0753 REAL LIFE DOSE REDUCTION OF BIOLOGICAL THERAPY IN PATIENTS WITH INFLAMMATORY RHEUMATIC DISEASES. UTILITY OF THE REDOSER TOOL." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1502.1–1502. http://dx.doi.org/10.1136/annrheumdis-2022-eular.445.

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BackgroundThe long-term use of standard dosing of TNFi therapy is costly and not without side effects, including infections, tuberculosis and potential malignancies(1,2,). Hence, we undertook this study to determine whether dose reduction of TNFi therapy may be possible in a realworld setting and if REDOSER tool(3) is an appropriateness criteria for reducing the dose of BT.ObjectivesDescribe the percentage of patients with inflammatory rheumatic diseases (IRD) who continue with dose reduction of biological therapy (BT). Evaluate relapse in clinical practice after 2 years of follow-up. Identify factors associated with relapse.MethodsRetrospective observational study. Patients with axial spondyloarthritis (axial SpA), psoriatic arthritis (PSA) and rheumatoid arthritis (RA) in BT dose reduction. Inclusion criteria: Axial SpA according to ASAS criteria, APS according to CASPAR criteria and RA according to ACR2010 criteria, who have started reducing the dose of BT treatment between 2009-2019 at the Hospital Regional Universitario de Málaga, Spain. Protocol: patients with TB are followed prospectively in a monographic consultation with a pre-established protocol. The day of dose reduction = baseline visit (v0). Variables:Maintained dose reduction: % of patients who maintained dose reduction from the start of optimization to the index date (data collection). Relapse at 12 and 24 months: % of patients who, after starting dose reduction, returned to the previous or usual dose. Other variables: Demographic, time to diagnosis and evolution of the disease, clinical-analytical: disease activity (DAS28, DAPSA and BASDAI) and physical function (HAQ, BASFI). Previous treatments. Appropriateness criteria for reducing the dose of BT according to REDOSER (1): 1.appropriate, 2. inappropiate, 3. uncertain. Statistical analysis: Descriptive, bivariate, multivariate logistic regression (VD: relapse).ResultsOne hundred twenty-nine patients with axial SpA, PSA and RA in BT dose reduction were included. The mean time from the start of BT to dose reduction was 38.1 months (16.6-73.1). The mean time in dose optimization was 19.5(±15.7) months. At the end of follow-up, 70.2% of the patients (87pts) achieved a sustained dose reduction. At 12 months and 24 months, 12.4% and 11.6% of patients relapsed, respectively. At the end of follow-up, there were no differences between baseline inflammatory activity and after 24 months in dose reduction measured by the different indexes: DAS28 (1.9[0.7] Vs 2.1[1, 7], p=0.323; DAPSA (5.4[4.9] Vs 4.8[4. 7], p=0.718, and BASDAI (1.5[1.1] Vs 1.4[1.3], p=0.867). Retrospectively, we evaluated the appropriateness of optimization according to the REDOSER tool (1) at the end of follow-up and it was observed that 85% of patients who maintained the dose reduction had an appropriate REDOSER and 14.5% uncertain and none inappropriate p<0.001.ConclusionDose reduction of BT in IRD is possible in most patients, maintaining low disease activity or remission at 24 months, compared to baseline.Relapse was associated with a longer evolution time of the IRD, a longer diagnostic delay, a higher inflammatory activity measured by the respective indices and a uncertain or inappropriate result of the REDOSER tool. This tool can be very useful used prior to the assessment of TB dose reductionReferences[1]Galloway JB, et al. Ann Rheum Dis 2011;70:1810_4.[2]Dixon WG, et al. Ann RheumDis 2010;69:522_8.[3]González-Álvaro I, Blasco AJ, Lázaro et al. Heliyon. 2017 Nov 14;3(11):e00452.Disclosure of InterestsSara Manrique Arija Speakers bureau: Abbvie, Gedeon, Jansen, Lilly, Menarini, MSD, Novartis, Pfizer, Roche, Sanofi, UCB.Consultant of: Abbvie, Jansen, Lilly, Novartis, Sanofi.Alba María Cabezas-Lucena: None declared, FJavier Godoy-Navarrete: None declared, Maria Morales-Águila: None declared, Rocio Redondo: None declared, Natalia Mena-Vázquez: None declared

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Michalak, Agata, Katarzyna Laskowska, Piotr Radwan, Beata Kasztelan-Szczerbinska, Marek Cybulski, and Halina Cichoz-Lach. "Platelet indices as potential biomarkers for determining active ulcerative colitis and assessing the efficacy of biological treatment – experience of a single centre – a pilot study." Current Issues in Pharmacy and Medical Sciences 32, no. 4 (December 1, 2019): 225–28. http://dx.doi.org/10.2478/cipms-2019-0038.

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Abstract Various laboratory parameters are commonly used to assess the efficacy of biological treatment (BT). The aim of our study was to assess the correlation between platelet (PLT) indices: (mean platelet volume (MPV), plateletcrit (PCT), platelet distribution width (PDW)), C-reactive protein (CRP) and endoscopic picture in the course of infliximab induction regimen in ulcerative colitis (UC) patients. The study enrolled 46 patients with UC – 32 men and 16 women. They were administered infliximab (standard induction therapy). Laboratory tests (CRP and PLT indices) and colonoscopy were performed in all patients during the induction regimen – at 0, 2, and 6 weeks and in follow-up six weeks after the completion of induction therapy. The study revealed a statistically significant decrease in CRP and PLT, and an increase in MPV, together with improvement of endoscopic picture (p <0.001) (MAYO score, MAYO endoscopic subscore) in all patients. PCT and PDW values remained in normal ranges before BT and after the finish of the induction regimen. PCT correlated positively with CRP before the introduction of BT (p = 0.018). In addition, positive correlations between PCT and PLT count were noticed before infliximab induction regimen and in follow-up after the finished of therapy (p <0.001). Additionally, a negative correlation between PLT count and MPV prior to the first dose of infliximab was observed (p=0.032). Our data suggest that PLT indices could be useful biomarkers for determining active UC and for assessing the efficacy of BT. From what we know, this is the first survey devoted to PLT parameters in Polish patients with UC.

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Vega, L., I. Calvo, O. Ibarguengoitia, J. M. Blanco, D. Montero, C. García, M. E. Ruiz, et al. "SAT0095 REAL LIFE SEVERE INFECTIONS IN PATIENTS WITH RHEUMATOID ARTHRITIS ON TREATMENT WITH BIOLOGICAL THERAPY AND JAKI." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 981.1–981. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3691.

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Background:Infections are one of the main complications among patients with rheumatoid arthritis (RA) with immunosuppressive treatment. The differences between treatments and the influence of other factors is unclear.Objectives:To evaluate the frequency and factors associated with serious infections in patients with RA treated with biological therapy (BT) and JAKi and the differences between treatments.Methods:Descriptive and retrospective study (January 2015-December 2019) of patients with RA treated with BT (TNFi, non-TNFi) and JAKi (tofacitinib, bariticinib) in a single center. Severe infection was considered a life-threatening infection or one that required hospitalization and intravenous treatment. Epidemiological variables, clinical characteristics, Charlson comorbidity index, type of BT or JAKi and concomitant treatment were collected.For the analysis frequencies and percentages are used in qualitative variables, and mean ± SD in the quantitative ones. Statistical analysis was performed with IBM SPSS v 23.Results:We registered 246 patients (85% women) mean aged 55.8±13.5 years. RF was positive in 87%, anti-CCP in 75.6% and 15.4 % presented extra-articular manifestations (nodulosis 8.9%, intersticial lung disease 5.3%, other 1.2%). At the start of the study 149 patients (60.6%) were with TNFi, 79 (32.1%) non-TNFi and 18 (7.3%) with JAKi and non-biologic DMARD (nbDMARDs) were used in 84.1% of cases (methotrexate 71.2%, leflunomide 21.4%, other 7.4%).During the study 176 patients (71.5%) continued with the same treatment and in 70 (28.5%) it was changed at least once. 5 patients discontinued the treatment. At the end of the study, 124 patients (50.4%) were with TNFi, 83 (33.7%) non-TNFi and 34 (13.8%) with JAKi.Severe infection was developed in 17 (6.9%) patients (respiratory 7, se sis 4, urinary 3, cellulitis 2, osteomyelitis 1) among them 2 patients had severe infection and herpes zoster and 3 developed a second infection. 9 patients were with TNFi (52.9%), 6 non- TNFi BT (35.3%) and 2 JAKi (11.8%). Table 1TABLE 1.CHARACTERISTICS OF PATIENTS WITH INFECTION VS. WITHOUT INFECTIONINFECTIONYESn:17NOn:229pFEMALE,n (%)13 (76.5)196 (85.6)0.297AGE years,(mean±SD)60.8 ± 1355.4 ± 13.50.112AGE ≥ 65n (%)9 (52.9)63 (27.5)0.070RF +,n (%)17 (100)197 (86)0.139ANTI-CCP +,n (%)14 (82.4)172 (75.1)0.770ILD,n (%)1 (25)12 (35.3)0.708ALCOHOL, n (%)1 (5.9)19 (8.3)1.00SMOKER, n (%)5 (29.4)60 (26.2)0.772COPD, n (%)5 (29.4)24 (10.5)0.036*DM, n (%)7 (41.2)19 (8.3)0.001*SEVERE LIVER DISEASE, n (%)2 (11.8)1 (0.4)0.013*RENAL INSUFFICIENCY,n (%)2 (11.8)3 (1.3)0.040*PERIPHERAL VASCULAR DISEASE, n (%)7 (41.2)25 (10.9)0.003*CHARLSON INDEX(mean±SD)2.35 ± 2.10.66 ± 1.20.014*TNFi, n (%)9 (52.9)115 (50.2)NON-TNFi n (%)6 (35.3)77 (33.6)JAKi, n (%)2 (11.8)32 (14)nbDMARDs,n (%)12 (70.6)156 (68.1)0.833GCC, n (%)13 (76.5)115 (50.2)0.037*The inflammatory activity of RA was mild at the time of infection (DAS28: 2.7±1.2). The median time until infection was: TNFi 28.05 months, non- TNFi BT 25.03 and Jakinibs 16.97.The Charlson index, concomitant treatment with glucocorticoids (GCC) (not treatment with nbDMARDs), chronic obstructive pulmonary disease (COPD), diabetes (DM), severe liver disease and moderate-severe renal insufficiency were statistically significantly associated with infection. Table 1Conclusion:In our study, 6.9% of patients with RA treated with BT or JAKi developed severe infection during 4 years of follow-up. Concomitant GCC therapy and comorbidity increased the risk of presenting this complication.Disclosure of Interests:None declared

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Herrero-Morant, A., J. L. Martín-Varillas, S. Castañeda, I. González-Mazón, O. Maiz, A. Blanco, J. Sánchez, et al. "POS1371 BIOLOGICAL THERAPY IN REFRACTORY NEUROBEHÇET’S DISEASE. MULTICENTER STUDY OF 42 PATIENTS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 967–68. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3407.

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Background:Neuro-Behçet’s disease (NBD) is a severe complication of Behcet’s disease (BD). Despite well-established therapies with glucocorticoids and conventional immunosuppressants (cIS), a significant proportion of patients are refractory.Objectives:To assess efficacy and safety of biologic therapy (BT) in NBD refractory to glucocorticoids and at least one cIS.Methods:Open-label multicenter study of refractory NBD from 23 different referral Spanish Hospitals. Main outcome was neurological response. Secondarily, analytical efficacy was measured by Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP) and Hemoglobin (Hb) at baseline, 6 months, 1 year and 2 years.Results:We studied 42 patients (21 women/ 21 men; mean age 40.4±10.8 years). HLA B51 was positive in 15 out of 37 (40.5%) patients tested. Non-neurological manifestations were oral ulcers (n=41, 97.6%), genital ulcers (n=31, 73.8%), skin lesions (n=28, 66.7%), arthralgia (n=27, 64.3%), uveitis (n=21, 50.0%), arthritis (n=9, 21.4%), venous thrombosis (n=9, 21.4%) and arterial thrombosis (n=4, 9.5%). The underlying neurologic manifestation were parenchymal (n=34, 81.0 %) and non-parenchymal (n=17, 40.5%) involvement (Table 1). The first BT used was infliximab (n=20), adalimumab (n=13), golimumab (n=3), tocilizumab (n=3) and etanercept (n=2).After 58.2±51.4 months since initiation of BT, neurological response was complete (n=27; 64.3%), or partial (n=11, 26.1%) (Figure 1). Only 4 (9.5%) patients did not respond. After 6 months of BT, ESR improved from.31.5±25.6 to 15.3±11.9 mm/h (p=0.005), CRP from 1.4 [0.2-12.8] to 0.3[0.1-3] mg/dL (p= 0.002) and Hb from 13.1±1.6 to 13.8±1.3 g/dL (p=0.005).Figure 1.Neurological clinical response to biological therapy.Primary failure was observed in 16 (38.1%) patients due to inefficacy (n=11, 68.8%) or adverse effects (n=5, 31.3%). Similarly, causes of secondary failure (n=6, 14.3%) were inefficacy (n=5, 83.3%) and adverse effects (n=1, 16.7%). No serious adverse effects were observed.Conclusion:BT, especially monoclonal anti-TNF drugs, seems to be effective and safe in refractory NBD.Table 1.Neurologic manifestation of 42 patients with refractory neurobehçet's disease treated with biologic therapy.Parenchymal subtype, n (%)34 (81.0)-Hemiparesis8 (19.1)-Polineuropathy8 (19.1)-Encephalopathy6 (14.3)-Cognitive impairments4 (9.5)-Optic neuropathy4 (9.5)-Ophtalmoparesis4 (9.5)-Other cranial nerve involvement3 (7.1)-Hemihypoesthesia3 (7.1)-Cerebellar dysphasia1 (2.4)-Cerebellar involvement1 (2.4)-Non-steroidal psicosis1 (2.4)Non-parenchymal subtype, n (%)17 (40.5)-Aseptic meningitis12(28.6)-Thrombosis4 (9.5)-Intracranial hypertension1 (2.4)Disclosure of Interests:Alba Herrero-Morant: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Lilly, Janssen, and Celgene, Santos Castañeda: None declared, Iñigo González-Mazón: None declared, Olga Maiz: None declared, Ana Blanco Speakers bureau: AbbVie, Julio Sánchez: None declared, Norberto Ortego: None declared, Enrique Raya Speakers bureau: MSD, Grant/research support from: AbbVie, Alejandro Olive: None declared, Anahy Brandy-Garcia: None declared, Águeda Prior-Español: None declared, Clara Moriano: None declared, Elvira Diez Alvarez: None declared, Rafael Melero: None declared, Jenaro Graña: None declared, Álvaro Seijas-López: None declared, ANA URRUTICOECHEA-ARANA: None declared, Angel Ramos Calvo: None declared, Concepción Delgado Beltrán: None declared, Marta Loredo Martínez: None declared, Eva Salgado-Pérez: None declared, Francisca Sivera: None declared, Ignacio Torre-Salaberri: None declared, J. Narváez Speakers bureau: Bristol-Myers Squibb, José Luis Andréu Sánchez: None declared, Olga Martínez González: None declared, Ricardo Gómez de la Torre: None declared, Sabela Fernández: None declared, Susana Romero-Yuste: None declared, Gerard Espinosa: None declared, Miguel Á. González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Sanofi, Lilly and MSD, Grant/research support from: AbbVie, MSD, and Roche

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Jara, Carlos, Isabel Alvarez, Mireia Margeli Vila, Cesar Augusto Rodriguez, Purificacion Martinez, J. Norberto Batista, Jose Luis Alonso Romero, et al. "First results of a prospective registry in unresectable locally advanced or metastatic breast cancer patients: GEICAM/2014-03 (RegistEM)." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 1077. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.1077.

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1077 Background: In Spain there is limited prospective data for unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (MBC) patients (pts) treated as per clinical practice. RegistEM study will provide epidemiological, pathological and clinical data, including treatments given for different disease stages. Understanding the real distribution of the different BC subtypes is the primary objective. Methods: This is a non-interventional cohort study enrolling approximately 1,400 pts with advanced disease diagnosed from January 2016 to December 2018, either after recurrence or as first diagnosis, in 38 Spanish sites. Biological samples (primary tumor, metastatic lesions, blood) are currently being collected. In this first analysis, we include 489 pts who met study criteria before October 31, 2017. All data are described in two subgroups: on the most recent tumor lesion or on the primary breast tumor. Results: At first diagnosis, 67.9%, 31.5% and 0.6% of pts had early BC (EBC), MBC and ULABC, respectively. In the total analysis population, median age at diagnosis of advanced disease was 59.6 years, most of pts were white (98.2%), female (99.4%) and postmenopausal (70%). Family history of BC and ovarian cancer was reported in 5.7% pts. In ~390 pts BC clinical subtypes distribution was luminal B(HER2-)-like (~55%), luminal B(HER2+)-like (~16%), luminal A-like or triple negative (TN) (~10% each) and HER2 enriched-like (~8%). Median time to recurrence (years) in EBC pts was: luminal A-like 5.8, luminal B(HER2-)-like 5.1, luminal B(HER2+)-like 3.9, HER2 enriched-like 2.7 and TN 1.7. Bone (59%), visceral (58%) and lymph node (27%) lesions were the most frequent metastatic locations. The two most frequent therapies in first line consisted in: endocrine therapy (ET) (47%) and ET+biological therapy (BT) (29%) for luminal A-like; ET (32%) and ET+BT (32%) for luminal B(HER2-)-like; chemotherapy (CT)+ET+BT (43%) and CT+BT (24%) for luminal B(HER2+)-like; CT+BT (68%) and CT (16%) for HER2 enriched-like; CT (59%) and CT+BT (34%) for TN. Conclusions: These first data confirm that luminal B (HER2-)-like subtype is the most predominant in MBC.

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Seck, Moussa, Alioune Badara Senghor, Mossane Loum, Sokhna Aissatou Touré, Blaise Félix Faye, Alioune Badara Diallo, Mohamed Keita, et al. "TRANSFUSION PRACTICE, POST-TRANSFUSION COMPLICATIONS AND RISK FACTORS IN SICKLE CELL DISEASE IN SENEGAL, WEST AFRICA." Mediterranean Journal of Hematology and Infectious Diseases 14, no. 1 (January 1, 2022): e2022004. http://dx.doi.org/10.4084/mjhid.2022.004.

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Context and Objectives: Blood transfusions (BT) remain a mainstay of therapy for patients with sickle cell disease (SCD), but pose significant clinical challenges. We aim to assess infectious markers, red cell alloimmunization and iron overload secondary to BT in SCD patients. Materials and Methods: This is a case-control study included 253 SCD (153 SCD-transfused and 100 SCD non-transfused). We evaluated the transfusion practice (modalities, indications), post-transfusion complications (infections, alloimmunization, iron overload) and risk factors of these complications (socio-demographic, clinical, biological). Results: Median age was 28.5 years (5 - 59). Sex ratio was 0.86. Homozygous SCD was more common (95.3%). Simple BT was performed in 92.8% and transfusion exchange in 18.9%. Transfusion indications were dominated by acute anemia (57.06%) and vaso-occlusive crisis (VOCs) (14%). Red blood cell concentrates (RBC) were administered to 93.46%. Median number of RBC received per patient was 10 (2 - 48). The prevalence of VHC in SCD-transfused was 1.33% and 2% for VHB. Anti-HIV antibodies were not found. Red cell alloimmunization frequency was 16%. The most common alloantibodies were anti-rhesus (34.19%) and anti-Kell (23.67%). Iron overload was detected in 7.84%. The number of RBC transfused was the only risk factor for alloimmunization (p = 0.03) and iron overload (p = 0.023). BT frequency was not related to infectious transmission. Conclusion: Despite advances in blood safety, BT therapy is still a risk for SCD polytransfused patients. Although infectious transmission has rare, the risk of alloimmunization and iron overload is high in these patients.

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Herrero-Morant, A., D. Martínez-López, L. Sanchez-Bilbao, I. Gonzalez-Mazon, J. L. Martín-Varillas, R. Fernández Ramón, C. Álvarez-Reguera, M. Á. González-Gay, and R. Blanco. "POS1347 BIOLOGICAL THERAPY IN NEUROSARCOIDOSIS. STUDY OF 30 PATIENTS FROM A SERIES OF 234 SYSTEMIC SARCOIDOSIS FROM A UNIVERSITY HOSPITAL." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1011.2–1012. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2878.

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BackgroundNeurosarcoidosis (NS) is a severe complication of sarcoidosis [1,2]. NS may be classified according to several subtypes [1]. Data on therapy, including biological therapy (BT) is scarce.ObjectivesTo assess efficacy and safety of BT in refractory NS subtypes.MethodsStudy of NS from a large cohort (n=234) of all consecutive patients diagnosed with sarcoidosis in a single university hospital from January 1, 1999 to December 31, 2019. Diagnosis of sarcoidosis was established according to ATS/ERS/WASOG criteria [3].Efficacy was considered as complete or partial response and no-response according to the resolution of the neurological syndrome (signs and/or symptoms) after the BT onset.ResultsNS was observed in 30 (19 women/11 men) of 234 (12.8%) patients; mean age, 55.0±15.8 years. NS subtypes were chronic headache (n=13, 43.4%), peripheral neuropathy (n=6, 20%), cranial neuropathy (n=5, 16.7%), spinal cord abnormalities (n=3, 10%) and aseptic meningitis (n=3, 10%). A total of 26 (86.7%) patients received oral corticosteroids (CT) (mean maximum dose: 50±19.2 mg/dL) and 7 (23.3%) IV CT. In addition, conventional immunosuppressants were administered to 18 (60%) patients and BT to 12 (40%) patients. No treatment was administered to 4 (13.3%) patients. Table 1 shows treatment according to NS subtypes.Table 1.Treatment of 30 patients with neurosarcoidosisNeurosarcoidosis subtypen (%)Other clinical manifestationsn (%)Conventional immunosuppressant,N=23n (%)monoclonal anti-TNFα, N=22 n (%)Etarnecept, N=1n (%)Tocilizumab, N=1n (%)Secukinumab, N=1 n (%)Rituximab, N=1 n (%)Chronic headache*13 (43.4)P (n=9, 69.2%)A (n=9, 69.2%)C (n=6, 46.2%) O (n=4, 30.8%)D (n=4, 30.8%)MTX (n=6, 26.1%) AZA (n=1, 4.3%)IFX (n=1, 4.5%)ADA (n=1, 4.5%)GLM (n=1, 4.5%)0 (0)01 (4.5)1 (4.5)Peripheral neuropathy6 (20.0)P (n=5, 83.3%)A (n=3, 50%)O (n=3, 50%) C (n=2, 33.3%)MTX (n=4, 17.4%) AZA (n=2, 8.7%)IFX (n=3, 13.6%)ADA (n=2, 9.1%)GLM (n=1, 4.5%)1 (4.5)000Cranial neuropathy5 (16.7)P (n=4, 80%) O (n=3, 60%)C (n=1, 20%)A (n=1, 20%)D (n=1, 20%)AZA (n=4, 17.4%)MTX (n=3, 13.1%)IFX (n=3, 13.6%)ADA (n=1, 4.5%)0000Spinal cord abnormalities3 (10.0)P (n=3, 100%)O (n=1, 33.3%)C (n=1, 33.3%)A (n=1, 33.3%)MTX (n=1, 4.3%)IFX (n=1, 4.5%)GLM (n=1, 4.8%)0000Aseptic meningitis3 (10.0)P (n=2, 66.7%)O (n=1, 33.3%)C (n=1, 33.3%)A (n=1, 33.3%)MTX (n=2, 8.7%)IFX (n=2, 9.1%)ADA (n=1, 4.5%)01 (4.5)00TOTAL(n= 30)30 (100)P (n=23, 76.7%)A (n=15, 50%)O (n=12, 40%)C (n=11,36.7%)D (n=5, 16.7%)MTX (n=16, 69.6%) AZA (n=7, 30.4%)IFX (n=10, 45.5%)ADA (n=5, 22.7%)GLM (n=3, 13.6%)1 (4.5)1 (4.5)1 (4.5)1 (4.5)Abbreviations: A: Articular, ADA: Adalimumab, AZA: Azathioprine, C: Cutaneous, D: Digestive, GLM: Golimumab, IFX: Infliximab, MTX: Methotrexate, O: Ocular, P: Pulmonar*With MRI, CSF, and/or EMG/NCS findings typical of granulomatous inflammation of the nervous system after rigorous exclusion of other causes and not meeting criteria for other neurosarcoidosis subtypes.A total of 12 patients received treatment with 22 BT. Most used BT were monoclonal anti-TNFα (n=18, 81.8%), infliximab (IFX) (n= 10, 45.5%) and adalimumab (ADA) (n=5, 22.7%). After 12 months since the initiation of BT, complete, partial or no response was observed in 14 of 17 (82.4%), 2 (11.8%) and 1 patient (5.9%), respectively (Figure 1). Severe allergic reaction was observed in one patient on both IFX and ADA. No more severe adverse events were observed.Figure 1.Neurological clinical response to biological therapyConclusionBT, especially monoclonal anti-TNFα, seems to be effective and safe in NS, regardless of subtype.References[1]J. Bradshaw M, et al. Neurol Neuroimmunol Neuroinflamm 2021;8:e1084. doi:10.1212/NXI.0000000000001084[2]Riancho-Zarrabeitia L, et al. Clin Exp Rheumatol. 2014 Mar-Apr;32(2):275-84. PMID: 24321604.[3]Statement on Sarcoidosis. Am J Respir Crit Care Med [Internet] 1999;160(2): 736–55. https://doi.org/10.1164/ajrccm.160.2.ats4-99Disclosure of InterestsAlba Herrero-Morant: None declared, David Martínez-López: None declared, Lara Sanchez-Bilbao: None declared, Iñigo Gonzalez-Mazon: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Lilly, Janssen, UCB, and Celgene, Raúl Fernández Ramón: None declared, Carmen Álvarez-Reguera: None declared, Miguel Á. González-Gay Speakers bureau: Abbvie, Roche, Sanofi, Lilly, Celgene, Sobi, and MSD, Grant/research support from: Abbvie, MSD, Janssen, and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, BMS, Janssen, and MSD, Grant/research support from: Abbvie, MSD, and Roche

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Drexel, S. C., M. Klietz, K. Kollewe, L. Paracka, A. Kutschenko, B. Kopp, F. Lange, F. Wegner, and D. Dressler. "Caregiver burden and health-related quality of life in idiopathic dystonia patients under botulinum toxin treatment: a cross-sectional study." Journal of Neural Transmission 127, no. 1 (December 4, 2019): 61–70. http://dx.doi.org/10.1007/s00702-019-02109-6.

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AbstractDystonia is a chronic movement disorder that is associated with a reduction in health-related quality of life (HR-QoL) and restriction of activities of daily living. Botulinum neurotoxin (BT) improves disease-specific HR-QoL by reducing abnormal movements, postures, and pain. We examined the burden of the corresponding primary caregiver as a potential important factor for disease management and HR-QoL of dystonia patients under treatment with BT. 114 patients with focal, segmental, or generalized dystonia were recruited, together with 93 corresponding caregivers, whose burden was investigated using the Caregiver Burden Inventory. In addition, all participants were assessed for cognitive impairment, depression, anxiety, alexithymia, and HR-QoL. Only a small proportion of caregivers suffered from caregiver burden. Despite BT therapy, patients’ HR-QoL was decreased compared to the age-matched general German population. Psychological symptoms, notably anxiety, and depression correlated significantly with reduced HR-QoL. Our data imply that caregiver burden emerged to be an issue in subgroups of dystonia patients. Furthermore, HR-QoL of dystonia patients is reduced even under optimized BT treatment in a specialized center.

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Vega, L., I. Calvo, O. Ibarguengoitia, D. Montero, C. García, J. M. Blanco, M. E. Ruiz, et al. "AB0153 REAL LIFE SEVERE INFECTIONS IN PATIENTS WITH RHEUMATOID ARTHRITIS ON TREATMENT WITH BIOLOGICAL THERAPY AND JAKI." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1104.1–1104. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1141.

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Background:Infections are one of the main complications among patients with rheumatoid arthritis (RA) with immunosuppressive treatment. The differences between treatments and the influence of other factors is unclear.Objectives:To evaluate the frequency and factors associated with serious infections in patients with RA treated with biological therapy (BT) and JAKi and the differences between treatments.Methods:Descriptive and retrospective study (January 2015-December 2020) of patients with RA treated with BT (TNFi, non-TNFi) and JAKi (tofacitinib, bariticinib, upadacitinib) in a single center. Severe infection was considered a life-threatening infection or one that required hospitalization and intravenous treatment. Epidemiological variables, clinical characteristics, Charlson comorbidity index, type of BT or JAKi and concomitant treatment were collected.For the analysis frequencies and percentages are used in qualitative variables and mean ± SD in the quantitative ones. Statistical analysis was performed with IBM SPSS v 23.Results:We registered 257 patients (84.4% women) mean aged 56.1±13.4 years. RF was positive in 86.8%, anti-CCP in 75.9% and 16.5 % presented extra-articular manifestations (nodulosis 9.7%, intersticial lung disease 4.3%, other 1.5%). At the start of the study, 157 (61.1%) patients were with TNFi, 80 (31.1%) with non-TNFi and 20 (7.8%) with JAKi. Conventional synthetic DMARDs (csDMARDs) were used in 86% of cases (methotrexate 71.1%, leflunomide 21.2%, other 7.7%).During the study, 162 (63%) patients continued with the same treatment and in 95 (37%) it was changed at least once. 3 patients discontinued the treatment. At the end of the study, 126 (49%) patients were with TNFi, 81 (31.5%) with non-TNFi and 47 (18.3%) with JAKi.Severe infection was developed in 28 (10.9%) patients (13 respiratory, 5 urinary, 5 cellulitis, 4 sepsis, 1 osteomyelitis) among them 2 patients had severe infection and herpes zoster at the same time and 3 developed a second infection. 14 (50%) patients were with TNFi, 8 (28.6%) with non-TNFi and 6 (21.4%) with JAKi. Table 1The inflammatory activity of RA was mild at the time of infection (DAS28: 2.6±1.1). The median time until infection was: TNFi 45.25 [4.9-202.3] months, non- TNFi 19.14 [4.9-72.5] months and JAKi 17.63 [1.1-29.2] months.The Charlson index, concomitant use of glucocorticoids (GCC) at lower doses than 10mg/d, chronic obstructive pulmonary disease (COPD), diabetes (DM), moderate-severe renal insufficiency, congestive heart failure (CHF) and peripheral vascular disease were statistically significantly associated with infection. Table 1.TABLE 1.CHARACTERISTICS OF PATIENTS WITH INFECTION VS. WITHOUT INFECTIONINFECTIONYES n:28NO n:229pFEMALE, n (%)22 (78.6)195 (85.2)0.406AGE years, (mean±SD)57.7 ± 13.955.9 ± 13.40.507AGE ≥ 65 n (%)10 (35.7)68 (29.7)0.513RF +, n (%)25 (89.3)198 (86.5)0.677ANTI-CCP +, n (%)21 (75)174 (75.1)1.00ILD, n (%)1 (3.5)10 (4.3)0.809ALCOHOL, n (%)3 (10.7)17 (7.4)0.465SMOKER, n (%)10 (35.7)60 (26.2)0.244COPD, n (%)7 (25)24 (10.5)0.026*DM, n (%)7 (25)19 (8.3)0.013*CHF, n (%)4 (14.3)1 (0.4)0.001*RENAL INSUFFICIENCY, n (%)3 (10.7)2 (0.9)0.010*PERIPHERAL VASCULAR DISEASE, n (%)9 (32.1)22 (9.6)0.002*CHARLSON INDEX (mean±SD)1.64 ± 2.10.63 ± 1.20.001*TNFi, n (%) NON-TNFi n (%) JAKi, n (%)14 (50)112 (48.9)8 (28.6)73 (31.9)6 (21.4)41 (17.9)csDMARDs, n (%)22 (78.6)159 (69.4)0.317GCC dose <10mg/d, n (%)17 (60.8)111 (48.5)0.007*Conclusion:In our study, 10.9% of patients with RA treated with BT or JAKi developed severe infection during 5 years of follow-up. Concomitant GCC therapy and comorbidity increased the risk of presenting this complication.Disclosure of Interests:None declared

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BATISTA, D. G. J., M. G. O. PACHECO, A. KUMAR, D. BRANOWSKA, M. A. ISMAIL, L. HU, D. W. BOYKIN, and M. N. C. SOEIRO. "Biological, ultrastructural effect and subcellular localization of aromatic diamidines in Trypanosoma cruzi." Parasitology 137, no. 2 (September 21, 2009): 251–59. http://dx.doi.org/10.1017/s0031182009991223.

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SUMMARYNo vaccines or safe chemotherapy are available for Chagas disease. Pentamidine and related di-cations are DNA minor groove-binders with broad-spectrum anti-protozoal activity. Therefore our aim was to evaluate the in vitro efficacy of di-cationic compounds – DB1645, DB1582, DB1651, DB1646, DB1670 and DB1627 – against bloodstream trypomastigotes (BT) and intracellular forms of Trypanosoma cruzi. Cellular targets of these compounds in treated parasites were also analysed by fluorescence and transmission electron microscopy (TEM). DB1645, DB1582 and DB1651 were the most active against BT showing IC50 values ranging between 0·15 and 6·9 μm. All compounds displayed low toxicity towards mammalian cells and DB1645, DB1582 and DB1651 were also the most effective against intracellular parasites, with IC50 values ranging between 7·3 and 13·3 μm. All compounds localized in parasite nuclei and kDNA (with greater intensity in the latter structure), and DB1582 and DB1651 also concentrated in non-DNA-containing cytoplasmic organelles possibly acidocalcisomes. TEM revealed alterations in mitochondria and kinetoplasts, as well as important disorganization of microtubules. Our data provide further information regarding the activity of this class of compounds upon T. cruzi which should aid future design and synthesis of agents that could be used for Chagas disease therapy.

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Nsibi, S., R. Ennaifer, B. Bouchabou, K. Ben Abdelghani, A. Fazaa, H. Ben Nejma, and A. Laatar. "AB0314 VIRAL HEPATITIS B REACTIVATION UNDER BIOLOGICAL THERAPY: SCREENING AND PREVENTION MODALITIES IN RHEUMATIC AND INFLAMMATORY BOWEL DISEASE PATIENTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1456.2–1456. http://dx.doi.org/10.1136/annrheumdis-2020-eular.748.

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Background:Viral hepatitis B reactivation (VHBr) is a serious complication of immunomodulatory therapy and in particular biological therapy (BT), which can be life-threatening, whence the adoption by societies of screening and prevention strategies based on the risk of VHBr which depends on serological status and the treatment used.Objectives:The objective of our study was to determine the modalities of HBV screening, to describe the prevalence of HBV infection in this group of patients, and to evaluate the VHBr prevention strategies adopted in our country.Methods:This was a retrospective, 8-year [2011-2018], single-centre, descriptive, retrospective study conducted in two departments: Rheumatology and Hepato-Gastroenterology. Patients under BT were included. Records with missing data were excluded. The modalities of screening and prevention of VHBr were determined and the prevalence of HBV markers was investigated.Results:One hundred patients were included: 85 followed up for chronic inflammatory rheumatic disease: rheumatoid arthritis (n=40), ankylosing spondylitis (n=41), juvenile idiopathic arthritis (n=4) and 15 patients followed up for inflammatory bowel disease (11 Crohn’s disease and 4 ulcerative colitis). The mean age was 44 years with a predominance of females (59%). The BTs prescribed were: anti-TNFα, anti-IL6 and antiCD20 in 83%, 11% and 7% respectively.HBV screening was done in 89% of cases: HBsAg was tested in 89%, anti-HBc in 64% and anti-HBs in 43%. Complete B serology (HBsAg, anti-HBc and anti-HBs) was performed in 40%.One patient had chronic hepatitis B on Entecavir for 3 years before starting anti-CD20 (HBsAg(+),anti-HBc(+)). A previous contact with HBV as evidenced by isolated anti-HBs(+) positivity was noted in 13 patients (20%).A negative B serology was noted in 30 patients (30%). The vaccination rate was 10%.Prophylaxis with Entecavir was indicated in 2 patients at high risk of viral B reactivation (candidates for anti-CD20 therapy and having anti-HBc(+) with undetectable viral load).One patient at moderate risk of reactivation (candidate for anti-TNF therapy and having anti-HBc(+)) was placed on Lamivudine for prophylaxis. Pre-emptive therapy based on monitoring of alanine aminotransferase (ALT) and HBV DNA levels every 1 to 3 months was indicated in 10 patients (with anti-HBc (+) and candidates for BT other than anti-CD20) but correctly applied in only 2 patients (20%). The remaining eight patients were monitored only for ALT levels. No cases of viral reactivation B were objectified.Conclusion:In our study, viral hepatitis B screening was done correctly in 40% of the cases. The rate of VHB vaccination was low (10%) despite the low cost of the vaccine. Prophylactic and pre-emptive treatment for viral reactivation were correctly applied in 100 and 20% of cases respectively. This underlines the difficulties encountered in applying pre-emptive treatment when access to HBV DNA level determination is limited and warrants more vigilance prior to the prescription of BT.Disclosure of Interests:None declared

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Herrero-Morant, A., J. L. Martín-Varillas, S. Castañeda, O. Maiz-Alonso, J. Sanchez-Martin, N. Ortego, E. Raya, et al. "POS0828 BIOLOGIC THERAPY IN REFRACTORY PARENCHYMAL AND NON-PARENCHYMAL NEUROBEHÇET DISEASE: NATIONAL MULTICENTER STUDY." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 704.3–705. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2681.

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BackgroundOcular and Neurobehçet’s Disease (NBD) are the most severe manifestations of Behcet’s disease (1-4). NBD can be classified as a) primary neural parenchymal lesions, also known as parenchymal NBD (p-NBD) or b) secondary to vascular involvement or non-parenchymal NBD (np-NBD) (4). Response to biologic therapy (BT) in these two refractory subtypes of NBD is unknown.ObjectivesTo assess efficacy and safety of BT in refractory subtypes of NBD.MethodsOpen-label multicenter study of refractory NBD from 21 different referral National Hospitals. NBD diagnosis was based on the International Consensus Recommendation criteria (4). Efficacy was determined by complete or partial response and no-response. Complete, partial or no response was defined according to the resolution of the neurological syndrome (signs and/or symptoms) after the BT onset.ResultsWe studied 41 patients (21 women/20 men; mean age: 40.6±10.8 years). NBD was classified as p-NBD (n= 33, 80.5%) and np-NBD (n=17, 41.5%). There were no significant differences in baseline general features and in neurological clinical response in both subgroups (Table 1 and Figure 1). The first BT used in p-NBD were Infliximab (IFX) (n=15), Adalimumab (ADA) (n=11), Golimumab (GLM) (n=3), Tocilizumab (TCZ) (n=2) and Etanercept (ETN) (n=2) and in np-NBD were IFX (n=9), ADA (n=6), TCZ (n=1) and ETN (n=1).Table 1.Main features of p-NBD and np-NBDTotalp-NBDnp-NBDP p-NBD vs np-NBDAge at biological therapy initiation, years (mean±SD)44±13.941.4±9.639.4±10.60.412Gender, n (m/f) (%)21/20 (48.8/52.2)18/15 (54.5/45.5)5/12 (29.4/70.6)0.091HLAB51 +/ patients tested, n (%)15/31 (57.7)14/25 (58.3)4/10 (40)0.391Oral aphthae, n (%)40 (97.6)32 (97)15 (88.2)0.323Cutaneous involvement, n (%)28 (63.4)23 (69.7)10 (58.8)0.603Ocular involvement, n (%)21 (48.8)15 (45.5)9 (52.9)0.616Vascular involvement, n (%)9 (22)10 (30.3)7 (41.2)0.442Articular involvement, n (%)9 (22)7 (21.2)3 (17.6)0.765Previous conventional Immunosuppressive drugs to BTAzathioprine24 (58.5)20 (60.6)10 (58.8)-Methotrexate16 (39.0)12 (36.4)3 (17.6)-Cyclophosphamide13 (31.7)13 (39.4)5 (29.4)-Cyclosporine A9 (22.0)8 (24.2)3 (17.6)-Mycophenolate Mofetil2 (4.9)2 (6.1)0-Figure 1.Response to biological therapy according to NBD subtypes.After an overall mean follow-up of 57.5±50.9 months BT was switched in 22 patients due to inefficacy (n=16) or Adverse Effects (AE) (n=6) and in 4 cases was definitively discontinued because of complete prolonged remission (n=3) or AE (n=1). AE were observed in 7 (17.1%) patients. Severe AE were observed in 2 cases, one due to demyelinating disease and the other due to pulmonary tuberculosis, both in patients undergoing IFX therapy. The other 6 AE were infusion reaction to IFX (n=1), IFX-induced psoriasis (n=1), IFX-induced acneiform eruption (n=1), infusion reaction to TCZ (n=1), intolerance to IFX and recurrent mild infections (n=1) and erosive lichen planus and bullous impetigo (n=1).ConclusionIn our series, BT seems equally effective and safe in both refractory p-NBD and np-NBD.References[1]Martín-Varillas JL, et al. Ophthalmology 2018 Sep;125(9):1444-1451. doi: 10.1016/j.ophtha.2018.02.020.[2]Atienza-Mateo B, et al. Arthritis Rheumatol 2019 Dec;71(12):2081-2089. doi: 10.1002/art.41026.[3]Santos-Gómez M, et al. Clin Exp Rheumatol 2016 Sep-Oct;34(6 Suppl 102): S34-S40.[4]Kalra S, et al. Diagnosis and management of Neuro-Behçet’s disease: international consensus recommendations. J Neurol. 2014 Sep;261(9):1662–76.Disclosure of InterestsAlba Herrero-Morant: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Lilly, Janssen, UCB, and Celgene, Santos Castañeda Paid instructor for: Assistant professor of the Cátedra UAM-ROCHE, EPID-Future, UAM, Madrid, Spain, Olga Maiz-Alonso: None declared, Julio Sanchez-Martin: None declared, Norberto Ortego: None declared, Enrique Raya: None declared, Águeda Prior-Español: None declared, Clara Moriano: None declared, Rafael Melero: None declared, Jenaro Graña: None declared, ANA URRUTICOECHEA-ARANA: None declared, Angel Ramos Calvo: None declared, Marta Loredo Martínez: None declared, Eva Salgado-Pérez: None declared, Francisca Sivera: None declared, Ignacio Torre-Salaberri: None declared, J. Narváez Speakers bureau: Bristol-Myers Squibb, José Luis Andréu Sánchez: None declared, Olga Martínez González: None declared, Ricardo Gómez de la Torre: None declared, Sabela Fernández: None declared, Susana Romero-Yuste: None declared, Iñigo Gonzalez-Mazon: None declared, Carmen Álvarez-Reguera: None declared, David Martínez-López: None declared, J. Luis Hernández: None declared, Miguel Á. González-Gay Speakers bureau: Abbvie, Roche, Sanofi, Lilly, Celgene, Sobi, and MSD, Grant/research support from: Abbvie, MSD, Janssen, and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, BMS, Janssen, and MSD, Grant/research support from: Abbvie, MSD, and Roche

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Arévalo, M., M. Moreno, V. Navarro-Compán, F. U. Pilar, E. De Miguel, T. Clavaguera, L. F. Linares Ferrando, B. Joven-Ibáñez, J. Gratacos-Masmitja, and X. Juanola-Roura. "AB0655 IMPACT OF BIOLOGIC THERAPY ON WORK IMPAIRMENT IN REAL LIFE IN AXIAL SPONDYLOARTHRITIS PATIENTS: DATA FROM REGISPONSERBIO." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1621.2–1622. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3150.

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Background:Biologic therapy (BT) has demonstrated its effect in improving work impairment in axial Spondyloarthritis (axSpA) patients in clinical trials, however there is few data of these effects in clinical practice.Objectives:-To assess the influence of BT in work status using the WPAI questionnaire in patients with axSpA in real life.-To compare work status between incident and prevalent cases with BT.-To evaluate factors related to changes in work status in these patients.Methods:REGISPONSERBIO is an observational, prospective and multicentric Spanish registry of SpA patients under biologic treatment recruited between September 2013 and December 2014. The study includes demographic, radiologic and disease data from both incident (starting biological therapy at the inclusion) and prevalent (already under biologic therapy at the inclusion) patients. WPAI (Work Productivity and Activity Impairment) questionnaire was used to assess work status (employment, lost hours, absenteeism and presenteeism) in both groups of patients at six months after study inclusion. Patients more than 65 years old who were not working were excluded from the analysis, as no changes in work impairment are expected in these individuals.A descriptive study of work status and related factors was performed using mean and standard deviation as appropriate. Work status was compared between both time-points in incidents and between incidents and prevalents. Uni and multivariate analysis for factors related to baseline work status were assessed, and correlation for change at six months.Results:The study included 75 incident and 134 prevalent axSpA patients. After start of BT, incident patients presented an increase in the number of patients who affirmed to be actively working and an improvement in absenteeism, lost hours and presenteeism, however statistical significance was only reached in the number of hours lost. Comparing incident and prevalent cases, incident patients showed worse data on work status compared to prevalent ones, but only presenteeism reached statistical significance. Factors related to absenteeism and presenteeism at study inclusion were disease activity variables (PGA, BASDAI, ASDAS-CRP), ASQoL and BASFI. Best correlation with improvement in absenteeism at six months was with change in BASDAI (0.84 p 0.07) and age (-0.56 p 0.11), and with improvement in presenteeism were BASFI (0.59 p 0.002), ASQoL (0.57 p 0.002), BASDAI (0.54 p 0.04), PGA (0.51 p 0.01) and ASDAS-CRP(0.51 p 0.01).Conclusion:Biologic therapy is associated to an improvement in work status in axSpA patients. The results suggest that the fast and high improvement in disease activity and disability observed after start of BT is not directly translated to an improvement in work status at short time. Disease activity, disability and quality of life were the main factors influencing both, work status at inclusion and improvement in absenteeism and presenteeism after BT was started.Disclosure of Interests:Marta Arévalo: None declared, Mireia Moreno: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Font Ugalde Pilar: None declared, Eugenio de Miguel Grant/research support from: Yes (Abbvie, Novartis, Pfizer), Consultant of: Yes (Abbvie, Novartis, Pfizer), Paid instructor for: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Speakers bureau: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Teresa Clavaguera Speakers bureau: novartis, BMS, Faes, Luis F. Linares Ferrando: None declared, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Xavier Juanola-Roura: None declared

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SELLA, A. "Evidence for a favorable effect of surgical resection of residual metastatic renal cell carcinoma (RCC) following biological therapy (BT)." European Journal of Cancer 29 (1993): S233. http://dx.doi.org/10.1016/0959-8049(93)91929-f.

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Páez Cancelado, C. C., R. García Duperly, J. Park, R. López Panqueva, E. E. Londoño Schimmer, A. M. Rey Rubiano, J. E. Padrón Mercado, et al. "P764 Phenotypic analysis of patients with inflammatory bowel disease: 23 year data of a centre in a South American country." Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S607. http://dx.doi.org/10.1093/ecco-jcc/jjz203.892.

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Abstract Background Inflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn Disease (CD). In the last decade, there have been introduced therapeutic changes that have revolutionised the pharmacologic and surgical management of patients with IBD. The incidence of UC and CD has been increasing in Latin America but the exact prevalence is unknown. Our objective is to describe the demographic characteristics, clinical and therapeutic aspects of the IBD in patients that have presented in the University Hospital Fundación Santa Fe de Bogotá (UH-FSFB), Colombia. Methods Retrospective Descriptive Cohort Study. Clinical histories, pathology reports, and endoscopic results from data base HI-ISIS of the UH-FSFB and medical data between January 1996 and February 2019 were recollected, stored in Excel and analysed using IBM SPSS Statistics Visor. Patients with diagnosis of IBD were included. Patients with incomplete clinical histories were excluded. Results From 398 patients included in this study, 72.1% had UC, 25.6% CD and 2.3% Indeterminate Colitis. The average age of diagnosis was 43.54 years (range: 12–91). In both patients with UC and CD there were smaller proportions of men than women (0.9:1 for UC and 0.7:1 for CD). Of the patients with UC, 46.3% had been hospitalised. 37.2% presented with proctitis, 23.8% left colitis and 39% with pancolitis. 13.5% had an asymptomatic clinical disease, 22.4% mild, 15.3% moderate, and 48.8% severe. 12.9% received biological therapy (BT). 24.3% of patients received a second line BT. Fifteen per cent required surgical interventions (SI), of which there were no mortalities. 27% who were receiving BT required SI. Of the patients with CD, 82.4% required hospitalisation. 43.1% had an ileal, 9.8% colonic, 39.2% ileal- colonic, 0% isolated upper digestive and 21.6% perianal compromise. 34.3% had non-stenosing behaviour, 49% stenosing and 16.7% penetrating. 44.1% of patients with CD received BT of which 40% required a second line BT. 55.9% required SI, of which 1 mortality was reported. 71.1% who were receiving BT required a SI. Conclusion Our study contributes to the epidemiology and integral management required by patients with IBD in our environment. More studies are recommended that replicate our methodology in the population with IBD in both Colombia and Latin America.

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Kariya, Shinji, Ichiro Yamasaki, Shingo Ashida, Kenji Tamura, Taro Shuin, Akihito Nishioka, and Yashuhiro Ogawa. "High-dose-rate brachytherapy combined with external beam radiotherapy for localized prostate cancer: Correlation between clinical and dosimetric parameters and the incidence of rectal bleeding." Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013): 213. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.213.

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213 Background: Several investigators have advocated that the alpha/beta ratio for prostate cancer is atypically low, and that hypofractionated radiotherapy or high-dose-rate brachytherapy (HDR-BT) regimens using appropriate radiation doses are expected to improve the local control rate for localized prostate cancer. However, the increase in the total biological effective dose (BED) may cause increased severity and incidence of normal tissue complications. The purpose of this study was to investigate what clinical and dosimetric factors affected the incidence of rectal bleeding after HDR-BT combined with external beam radiotherapy (EBRT). Methods: A total of 143 patients with localized prostate cancer underwent HDR-BT combined with EBRT. The fractionation schema for HDR-BT and EBRT was prospectively changed: 9 Gy x 2 + 2 Gy x 20 (BED1.5 = 219 Gy, BED3 = 139 Gy) in 57 patients (Group 1); and 9 Gy x 2 + 3 Gy x 13 (BED1.5 = 243 Gy, BED3= 150 Gy) in 86 patients (Group 2). Median follow-up was 59 (range, 36 – 94) months. The toxicities were graded based on the National Cancer Institute-Common Terminology Criteria for Adverse Events v3.0. Results: Sixteen (11.2 %) and one patients developed Grade 2 and 3 rectal bleedings, respectively. There were no significant differences between Group 1 and Group 2 in the incidence of Grade 2 and 3 rectal bleedings (12.3% and 11.6%, respectively). Grade 2 and 3 rectal bleedings occurred much more in the patients receiving the antiplatelet therapy (AT) (19.4%) than those without a history of AT (9.8%) and in the patients with diabetes mellitus (DM) (37.5%) than those without DM (10.4%). However, neither AT nor DM were risk factors in univariate analysis. Regarding dosimetric factors, V75 > 2cc, V90 > 0.2cc, D2 > 7 Gy, and D1 > 7.4 Gy were statistically-significant risk factors. In multivariate analysis, DM was the only statistically-significant risk factor. Conclusions: BED escalation could be performed without severe rectal bleeding in HDR-BT combined with EBRT. V75 > 2cc, V90 > 0.2cc, D2 > 7 Gy, D1 > 7.4 Gy, and DM were risk factors for the incidence of rectal bleeding in HDR-BT combined with EBRT. Clinical trial information: 18-9.

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Xie, Tongji, Yan Li, Xuezhi Hao, Yan Wang, Xingsheng Hu, Lin Wang, Shouzheng Wang, et al. "Transcriptional analysis of small cell lung cancer transformation in epidermal growth factor receptor mutated lung adenocarcinomas." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): e21100-e21100. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e21100.

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e21100 Background: Epidermal growth factor receptor ( EGFR)-mutated lung adenocarcinoma (LUAD) could benefit from EGFR-TKIs (tyrosine kinase inhibitors) treatment, but drug resistance seems to be inevitable. Small cell lung cancer (SCLC) transformation counts for 3-15% of the resistance mechanism, and was amply studied at genomics level but rarely at transcriptional level. Methods: The expression of 730 mRNAs were investigated by Nanostring nCounter Pancancer Pathway Panel on 72 formalin-fixed and paraffin-embedded (FFPE) samples from 27 EGFR-mutated LUAD patients with SCLC transformation after EGFR-TKIs therapy (19 LUAD samples before transformation, LUAD-BT; 21 SCLC samples after transformation, SCLC-AT), 12 EGFR-mutated LUAD patients never SCLC transformed after EGFR-TKIs therapy (12 samples, LUAD-NT) and 20 stage IIĨIV primary SCLC patients (20 samples, SCLC-P). For patients enrolled in LUAD-NT group, tissue biopsies were performed at least twice, which were all diagnosed as pure LUAD, and the overall survival (OS) since first line therapy was longer than the median transformation time (mTt) of SCLC-transformed patients in our study. mRNA expression patterns and biological pathway scores were compared among four groups. The candidate predictive biomarkers from mRNA expression pattern analysis were validated by area under curve (AUC) of receiver operating characteristic curve (ROC) and the logarithm of fold change to the base 2 (log2FC). Results: On the last day of follow up (1st February 2022), the shortest OS of LUAD-NT patients was 28.4 months, whereas the mTt was 27.5 months. Among four groups, LUAD-NT and LUAD-BT showed the most similar mRNA expression patterns, and SCLC-P were significantly different from the others. 8.6% (63/730) mRNA showed significant downregulation after SCLC transformation, while 3.6% (26/730) showed significant upregulation ( p value adjusted by Benjamin & Hochberg’s method < 0.05, SCLC-AT vs LUAD-BT). In pathway enrichment analysis, the score of RAS and TGF-β pathways were significantly lower in SCLC-AT than LUAD-BT. Compared with SCLC-P, 6 upregulated mRNAs in SCLC-AT were observed (log2FC > 2, AUC > 0.85 and each raw p value < 0.05), including AR, COL5A1, GHR, HMGA2, IGFBP3 and IL6R, which could be further validated as diagnostic markers in a larger cohort. Moreover, compared with LUAD-NT, 4 mRNAs ( BRIP1, CCNE2, CDKN2A and MCM2) were found to be significantly upregulated (log2FC > 1, AUC > 0.75 and each raw p value < 0.05) in LUAD-BT, indicating the predictive value of SCLC transformation. Conclusions: The transformation of LUAD to SCLC may be promoted by transcriptional events. We also described some significantly different expressed mRNAs that could candidate as predictive or diagnostic markers for SCLC transformation, which should be further validated in a larger cohort.

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Vega, L., O. Ibarguengoitia, C. García, M. Enjuanes, E. Galíndez-Agirregoikoa, I. Calvo, J. M. Blanco, et al. "AB0266 PREGNANCY PLANNING AND FOLLOW-UP IN MULTIDISCIPLINARY UNITS IMPROVES THE OUTCOMES IN WOMEN WITH INFLAMMATORY ARTHROPATHIES." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1260.1–1260. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2135.

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BackgroundWomen with inflammatory arthropaties (IA) have fertility problems and complications during pregnancy and frequently biological therapy (BT) is required for the disease control.ObjectivesTo evaluate pregnancy in women with IA in a multidisciplinary unit composed of Rheumatologists and Obstetricians: describe disease evolution, complications and treatment.MethodsRetrospective and descriptive study of the evolution of pregnancy in patients with IA [Rheumatoid Arthritis (RA), Spondyloarthritis (SpA), Psoriatic arthritis (PsA) and Juvenile Idiopathic Arthritis (JIA)] and follow-up in a multidisciplinary unit for more than 15 years (until December 2021). Demographics, maternal disease, time until conception, previous abortions and presence of antibodies were collected. In addition, during follow-up, treatment, abortions, cesarean sections (C-section), preterm births, disease activity and maternal/fetal complications were collected.ResultsWe registered 49 pregnancies (39 women): 27 RA (55.1%), 9 SpA (18.4%), 9 PsA (18.4%) and 4 JIA (8.1%). Maternal average age at diagnosis was 26.8±6.7 years and average age at childbirth/abortion was 34.5±5.3 years.It took an average time of 9±7.7 months to conceive. 8.2% received fertility treatment with in vitro fertilization techniques.AntiRo antibodies were registered in 6.3% of patients and 28.6% had at least 1 antiphospholipid antibody.At the time of gestational desire/gestation 24 women (13 RA, 5 SpA, 3 PsA, 3 JIA) were receiving BT: 14 certolizumab (CZP), 5 adalimumab (ADA), 4 etanercept (ETN). 1 patient was being treated with baricitinib (BARI). Due to pregnancy, ADA was changed to CZP in 3 women and BT was stopped in 6 cases (3 ETN, 2 ADA, 1 CZP) as well as BARI. In 2 cases, ADA was stopped at week 17 of pregnancy (medical indication). Pregnancy was completed with BT (CZP) in 15 cases.9 abortions were registered prior to follow-up in the unit (0.23 abortions/mother) and 3 (2 RA, 1 PsA) during follow-up (0.07 abortions/mother): 2 (1 RA, 1 PsA) of them in women with CZP. RA patient had positive antiphospholipid antibodies and was a smoker and the other one had moderate disease activity by the time of the abortion. C-section was performed in 26.1% of cases. Preterm birth (<37 weeks) happened in 8.2% (n: 4) of the pregnancies: 2 in women with CZP.A total of 19 different fetal/maternal complications were registered during follow-up: 8 in the BT group (42.1%) compared to 11 (57.9%) in the group without BT, being Intrauterine Growth Restriction (IUGR) more frequent among women with BT. Infections were not more common in patients with BT. Table 1.Table 1.COMPLICATIONSWITH BT (n, %) n: 17WITHOUT BT (n, %) n: 32IUGR3 (17.6)1 (3.1)LBW2 (11.8)2 (6.2)INFECTION1 (5.9)4 (12.5)CHOLESTASIS0 (0)2 (6.2)PREECLAMPSIA0 (0)1 (3.1)DM2 (11.8)1 (3.1)HIGH BLOOD PRESSURE0 (0)0 (0)NEPHROPATY0 (0)0 (0)NEONATAL LUPUS0 (0)0 (0)HEART BLOCK0 (0)0 (0)MALFORMATION0 (0)0 (0)HELLP SYNDROME0 (0)0 (0)TOTAL811Regarding concomitant treatment, low dose prednisone was used in 32.7% of pregnancies, hydroxychloroquine in 44.9%, sulfasalazine in 8.2% and acetylsalicylic acid in 51%. We didn´t find differences in the use of these treatments between the two groups.Median DAS28 among RA patients with available data was under 2.6 throughout pregnancy as well as previously and posteriorly. No differences in median DAS28 were found between women with BT and without BT. SpA patients had BASDAI lower than 4 in both groups during pregnancy and previously.ConclusionIn our series, as described in the literature, women with IA are older and more likely to have preterm births compared to general population. Appropriate disease control was maintained during pregnancy, also previously and afterwards. We registered more IUGR, low birth weight (LBW) and diabetes mellitus (DM) among women with BT but lower rate of infections. Given the low number of patients with BT no statistically significant conclusions about complications can be drawn. Therefore, more studies among pregnant women with BT are necessary.Disclosure of InterestsNone declared

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Manrique-Arija, S., I. Ureña, M. C. Ordoñez, V. Coret, L. Cano, F. G. Jimenez-Nuñez, N. Mena-Vazquez, et al. "AB1170 Cost Minimization Study After Dose Optimization of Anti-TNF Alpha in a Specialized Outpatient Clinic on Biological Therapy (BT)." Annals of the Rheumatic Diseases 74, Suppl 2 (June 2015): 1294.1–1294. http://dx.doi.org/10.1136/annrheumdis-2015-eular.4606.

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Pintér, H. K., K. K. Boros, E. Pálfi, and G. Veres. "Nutritional intake and body composition in children with inflammatory bowel disease." Developments in Health Sciences 2, no. 4 (September 3, 2020): 97–103. http://dx.doi.org/10.1556/2066.2019.00004.

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AbstractPurposeIn this study we assessed nutritional intake, body composition, and their relationship in patients with paediatric inflammatory bowel disease (IBD).MethodsWe conducted a longitudinal, prospective study of 38 patients' nutritional intake using 3-day food records (FR) and bioimpedance analysis of body composition. FR were evaluated by Nutricomp DietCAD software. Results were analysed with Microsoft Excel 2013 and IBM SPSS Statistics 22 software.ResultsPatients treated with biological and conventional therapy (CT) had a higher intake of vegetable protein and carbohydrate from starch than those treated earlier with exclusive enteral nutrition (EEN) in the remission phase (F = 5.926, F = 5.130, P < 0.05). The former EEN group had a higher intake of iron compared to the other two groups (F = 3.967, P = 0.036). Protein intake and fat-free mass (FFM) had a significant positive correlation, while added sugar correlated with body fat mass (BFM) in the same way (R2 = 0.122, R2 = 0.169, P < 0.05). Body-fat mass in patients of the biological therapy (BT) group overstepped the healthy median, and the FFM in the EEN group stayed under it.ConclusionsOur results confirm that it is essential to monitor body composition and not only measure body weight. Patients should be advised based on their body composition, therapy, and phase of the disease.

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Choi, Park, Cho, and Choi. "Cyclin D1 is Associated with Radiosensitivity of Triple-Negative Breast Cancer Cells to Proton Beam Irradiation." International Journal of Molecular Sciences 20, no. 19 (October 7, 2019): 4943. http://dx.doi.org/10.3390/ijms20194943.

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Proton therapy offers a distinct physical advantage over conventional X-ray therapy, but its biological advantages remain understudied. In this study, we aimed to identify genetic factors that contribute to proton sensitivity in breast cancer (BC). Therefore, we screened relative biological effectiveness (RBE) of 230 MeV protons, compared to 6 MV X-rays, in ten human BC cell lines, including five triple-negative breast cancer (TNBC) cell lines. Clonogenic survival assays revealed a wide range of proton RBE across the BC cell lines, with one out of ten BC cell lines having an RBE significantly different from the traditional generic RBE of 1.1. An abundance of cyclin D1 was associated with proton RBE. Downregulation of RB1 by siRNA or a CDK4/6 inhibitor increased proton sensitivity but not proton RBE. Instead, the depletion of cyclin D1 increased proton RBE in two TNBC cell lines, including MDA-MB-231 and Hs578T cells. Conversely, overexpression of cyclin D1 decreased the proton RBE in cyclin D1-deficient BT-549 cells. The depletion of cyclin D1 impaired proton-induced RAD51 foci formation in MDA-MB-231 cells. Taken together, this study provides important clues about the cyclin D1-CDK4-RB1 pathway as a potential target for proton beam therapy in TNBC.

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Mouchard, Alice, Romain Blaizot, Jenna Graille, Pierre Couppié, and Chloé Bertin. "Leprosy as immune reconstitution inflammatory syndrome in patients living with HIV: Description of French Guiana’s cases over 20 years and systematic review of the literature." PLOS Neglected Tropical Diseases 16, no. 3 (March 4, 2022): e0010239. http://dx.doi.org/10.1371/journal.pntd.0010239.

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Background HIV infection is highly prevalent in French Guiana, a territory where leprosy is also endemic. Since the introduction of Highly Active Antiretroviral Treatment (HAART) in the management of HIV, leprosy has been reported as part of the immune reconstitution inflammatory syndrome (IRIS). Methodology/Principal findings We aimed to present a general description of these forms of leprosy as IRIS, highlighting clinical and therapeutic specificities. A retrospective study was conducted in French Guiana, including patients living with HIV (PLHIV) with advanced infection (CD4 < 200/mm3) and developing leprosy or a leprosy reaction within six months of HAART initiation, from 2000 to 2020. Clinical, histological and biological data were collected for all these patients. Six patients were reported in French Guiana. A systematic review of the literature was conducted, and its results were added to an overall analysis. Overall, seventy-three PLHIV were included. They were mainly men (74%), aged 22–54 years (median 36 years), mainly from Brazil (46.5%) and India (32.8%). Most leprosy cases (56.2%) were borderline tuberculoid (BT). Leprosy reactions were frequent (74%), mainly type 1 reaction (T1R) (68.5%), sometimes intense with ulceration of skin lesions (22%). Neuritis was observed in 30.1% of patients. The outcome was always favorable under multidrug therapy (MDT), continuation of HAART and additional corticosteroid therapy in case of neuritis or ulceration. There was no relapse. Conclusion Leprosy as IRIS in PLHIV mainly presents as a BT leprosy in a T1R state, sometimes with ulcerated skin lesions. Response to MDT is usually good. Systemic corticosteroids are necessary and efficient in case of neuritis.

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Garcia Gomez, C. L., D. Montero, L. Vega, O. Ibarguengoitia, I. Calvo, C. E. Perez, J. M. Blanco, et al. "AB0686 IMPACT OF COVID19 IN SPONDYLOARTHRITIS (SPA) PATIENTS IN A TERTIARY HOSPITAL." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1376.1–1376. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2960.

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Background:This tertiary hospital is the referall centre of 360.000 inhabitants, population with a Covid seroprevalence of 8,4% at final 2020.Since march, we have had a special concern for rheumatologic patients with systemic diseases and under inmunosupressive agents, including disease modifying antirheumatic drugs (DMARDs) and biological therapy (BT). This is why a special protocol for this population was set. It included performance of serology (CLIA test) for patients under BT and PCR and CLIA testing prior to new treatments. PCR testing was also generally performed: if symptomatology consistent with Covid; before hospitalisation; to tight contacts of infected people; and before procedures.Objectives:To evaluate the impact of COVID-19 in our SpA patients in terms of severity of viral infection and its effect on SpA.Methods:Data of 665 SpA patients and confirmed Covid infection seen in our center from March 15th to December 15th was crossed. 3 miscoded patients with rheumatoid arthritis and 2 with non definite CLIA positivity were excluded. Finally 49 patients’ clinical records were reviewed. Data regarding epidemiologic features, SpA characteristics, comorbidities, therapy received, clinical activity before and after Covid, and severity of the infection was collected. IBM SPSS v23 was used for statistical analysis.Results:Among 49 SpA patients, 59% were male, mean aged 56,63 years (range 23-79). 62,2% presented at least 1 comorbidity. 65% were psoriatic arthritis. They mostly had longstanding disease (median 10,5 years -range- 1-35). Previously 63% had received DMARDs, mainly methotrexate, and 32 % BT.When Covid was diagnosed 37,2% were under DMARDs and 53% under BT (69,2% TNF inhibitors, 26,9% anti-Il 17, 3,9% ustekinumab). At this point, disease activity was controlled in 82% of patients (39% in remission, and 43% in low disease activity state). Only 18% showed moderate activity.Within the 49 patients, 34 were diagnosed by PCR and 15 by CLIA tests. 9 required hospitalisation, of whom 4 developed more severe disease (3 received glucocorticoid pulses and 2 tocilizumab). A woman with PsA under secukinumab presented pneumonia and PE. None required mechanical ventilation. There were no exitus.Due to Covid infection 9 patients (50%) stopped DMARDs treatment, (5 of them hospitalised). 9 patients withdrew BT after Covid diagnosis; 60% of the BT-hospitalised, and 28.5% of the BT- non-hospitalised. 1 suffered a flow with severe disease activity after withdrawal of Il-17 inhibitor.Conclusion:Prevalence of SARS cov 2 infection in SpA patients was not greater than in general population. Most were asymptomatic or suffered mild disease. Only 9 were hospitalised. Factors related to hospitalisation seem similar to those of general population, even if statistical significance was not found due to the small sample. BT does not seem to relate to hospitalisation in SpA and we had no deaths to date in them.More studies should be made to throw out conclusions.Baseline characteristics of SpA patients with confirmed Covid19Hospitalised (N 9)Non-hospitalised (N 40)Total (N 49)Mean age (range) – yr 62,56 (43-74)55,3 (23-79)56,63 (23-79)Male sex - no. (%) 6 (66,6) 23 (57,5) 29 (59,1)Smoking habit (active, ex-smokers) - no. (%) 2 (22,2) 23 (57,5) 25 (51)Non comorbidities - no. (%) 2 (22,2) 17 (42,5) 19 (38,8)Hypertension - no. (%) 3 (33) 14 (35) 17 (35)Diabetes - no. (%) 1 (11) 6 (15) 7 (14,2)Dyslipidemia - no. (%) 4 (44) 9 (22,5) 13 (26,5)Obesity (BMI >30) - no. (%) 4 (44) 12 (30) 16 (32,7)Chronic obstructive pulmonary disease - no. (%) 2 (22,2) 4 (10) 6 (12,2)Asthma - no. (%) 0 (0) 4 (10) 4 (8,2)Cardiopathy - no. (%) 1 (11,1) 8 (20) 9 (18,4)Median disease time since diagnosis (range) – yr 14, 5 (7-20) 10 (1-35) 10,5 (1-35)SpA type Psoriatic arthritis - no. (%) 8 (88,8) 24 (60) 32 (65,3) Ankylosing spondylitis - no. (%) 1 (11,1) 15 (37,5) 16 (32,7) Non-Rx ankylosing spondylitis - no. (%) 0 (0) 1 (2,5) 1 (2)Current treatment when diagnosed (N 48) DMARDs - no. (%) 6 (66,6) 12 (30)18 (37,5) BT - no. (%) 5 (55,5)* 21 (52,5) **26 (54,1) * 5 anti-TNF (1 etanercept), 2 anti Il-17, 1 anti Il-12-23.** 12 anti-TNF (4 etanercept), 5 anti Il-17.Disclosure of Interests:None declared

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Simian, D., P. Núñez, L. Flores, C. Figueroa, P. Ibáñez, U. Kronberg, J. Lubascher, G. Pizarro, and R. Quera. "P489 Are patients with inflammatory bowel disease receiving an adequate immunisation?" Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S429—S430. http://dx.doi.org/10.1093/ecco-jcc/jjz203.618.

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Abstract Background Inflammatory Bowel Disease (IBD) treatment may increase the risk of infections. Vaccines are part of the comprehensive IBD patient care. The aim of this study was to describe indications and adherence of immunisations in IBD and identify possible associated factors. Methods A cross-sectional, analytic study was conducted in patients from an IBD Program of a tertiary centre in Chile, between April – June 2019. Demographic and clinical data were obtained from the hospital IBD registry, approved by the local IRB. Patients were asked to answer a vaccine survey and complementary information was obtained from the National Immunization Registry. Descriptive and association statistic were used (χ2; p <0.05). Results A total of 243 patients were included (Table 1). The influenza vaccine rate has significantly increased (Figure 1), reaching 67% in 2019, being higher in women (66% vs. 34%; p 0.045) and patients in biological therapy (BT) (29% vs. 14%; p 0.011) (Table 1). Vaccination rates are shown in Figure 2. Combination of Influenza/Hepatitis B/Pneumococcus vaccines was administered in 56 patients (23%), significantly higher in patients with BT and with fewer years of IBD. Forty patients received a live virus vaccine, 18% were on immunomodulatory treatment. The survey showed that 57 patients (23%) have not been immunised with any vaccine, mainly due to lack of time, lack of medical prescription and high cost. Conclusion In this cohort, vaccination rates are low, however, adherence to Influenza vaccine has increased. Immunisation should be considered early by the multidisciplinary team, educating patients about its importance.

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Fomina, Daria S., Olga A. Mukhina, Marina S. Lebedkina, Elena N. Bobrikova, Dmitry O. Sinyavkin, Anton A. Chernov, and Valeriya I. Mikhailova. "Registry analysis of patients with severe allergic asthma and clinically relevant sensitization to fungal allergens treated with genetically engineered biologics." Consilium Medicum 24, no. 3 (May 19, 2022): 170–76. http://dx.doi.org/10.26442/20751753.2022.3.201442.

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Background. Fungal sensitization (FS) often escapes the attention of clinicians when assessing the spectrum of sensitization in patients with atopic diseases. According to cohort studies is found in 310% of the general population and in 720% of asthmatics; the proportion of patients with severe bronchial asthma (SBA) with HS ranges from 35 to 75%. Fungal conidia have a 1000-fold higher exposure and are among the most important clinically relevant allergens in asthma. Exposure to fungal allergens is capable of generating a sustained T2 response with production of proinflammatory cytokines such as IL-5 and 13, which is indirectly related to the severity of airway eosinophilia. The identification of specific serum IgE is considered the benchmark diagnostic sign of FS, and the encapsulated hydrophobic carrier polymer system is considered preferable to skin prick tests. The process of reclassifying diseases with fungal lung lesions is confusing treatment strategies, leaving the FS problem underestimated. A series of publications have shown that omalizumab and other biologics targeting IL-5 or IL-5 receptor (IL5R) alpha are effective in treating SBA with FS. However, there remains an unmet need in real clinical practice for standardized approaches to genetically engineered biological therapies (BT) for different phenotypes of SBA, especially those associated with impaired microbiological homeostasis and this type of sensitization. Aim. Using retrospective analysis of clinical-dynamic observational data from patients on BT treatment in a real clinical setting to determine phenotypic features of severe allergic bronchial asthma with FS and to perform additional detailed analysis of a cohort of patients on anti-IgE therapy. Materials and methods. A retrospective observational single-center registry study was conducted between June 2017 and August 2021 at the City Reference Center for Allergology and Immunology. The baseline cohort consisted of 198 patients with severe allergic AD who were in the initial phase of BT. Inclusion criteria: age of patients over 18 years; presence of severe allergic bronchial asthma. Complex initial examination of patients included determination of FS by two methods: ImmunoCap ISAC to fungal allergic components alt a1, alt 6 (fungi of genus Alternaria) and asp f1, asp f3, asp f6 (fungi of genus Aspergillus). Specific IgE determinations on fungal panels. Sensitization to fungi was detected in 47 people during allergy examination. The following criteria were considered in evaluation of response to omalizumab: AST score less than 19 and/or difference between initial AST score and this score in dynamics less than 3 points; FEV 1 score less than 80; combination of 2 listed criteria. The minimum period of BT was 16 weeks. Nonparametric methods of descriptive statistics were used: median, interquartile range. Differences were considered significant at p0.05. Data were statistically processed using nonparametric methods in IBM SPSS Statistics V-22 program. MannWhitney U-test and KruskalWallis one-way analysis of variance were used to compare quantitative characteristics. Fisher's 2 test was used to compare qualitative characteristics. Results. Characteristics of the eosinophilic phenotype of SBA combined with FS: middle-aged patients, more often women, with relatively early onset of AD and high baseline eosinophil levels before prescription of biological drug therapy. Concomitant atopic dermatitis and food allergies are additional frequent features of this phenotype. Analysis of the effect of FS on achieving response to omalizumab and further consideration of switching to alternative therapy in SBA and FS patients showed the need to avoid premature revision and perform no earlier than the 10th month of therapy due to delayed response formation. Given the aggressive impact of FS on the barrier functions of the bronchial tree epithelium, it is advisable to test patients for FS at the initial diagnosis of AD. In the presence of atopic dermatitis and/or food allergy as T2 comorbidities in patients with SBA, early testing for FS and increased control of local and systemic inflammation are appropriate, which may improve long-term outcomes and reduce risks of further damage to natural barriers. Conclusion. Further research on various aspects of FS and its role in allergic diseases is extremely relevant in the current context.

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Busquets-Pérez, N., C. Sánchez-Piedra, P. Vela-Casasempere, M. Freire-Gonzalez, C. Bohórquez, L. Expósito, B. Magallon, et al. "AB0751 SAFETY AND PERSISTENCE OF USTEKINUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS IN BIOBADASER." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1672.2–1672. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3195.

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Background:Ustekinumab has been efficacy and safety for psoriatic artritis in clinical trials.Objectives:To assess effectiveness, by means of drug persistence analisys, and safety of ustekinumab in patients with psoriastic arthritis in Biobadaser.Methods:BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. We identified patients aged 18 years or more with psoriatic arthritis on Ustekinumab. A descriptive analysis was performed.The persistence of ustekinumab therapy was calculated with a Kaplan-Meier curve and was compared with the persistence of anti-TNF, according to line treatment. Log Rank test was used to establish a comparison. Adverse events occurring with ustekinumab are described according to year treatment.Results:One hundred and twelve patients were on ustekinumab. Most of them were on their second or third line treatment: 53.57% more than one biological therapy (BT), 19.64% second BT, 26.79% were naïve for BT. Most of them were on 45 mg dose: 88.24%. Median duration of disease at Ustekinumab initiation was 10.1 SD 7.2 years; 69.23% had peripheral arthritis; 45.24% had obesity and 39.29% were overweight; 40,6% were on prednisone and 59.82% on DMARD. The cause of discontinuation of treatment was mainly inefficacy (82.61%) and less common an adverse event (6.52%). The probability of persistence of treatment with ustekinumab was 0.83 (95% CI 0.63-0.92) at year 1, 0.79 (0.58-0.90) at year 2 and 0.79 (0.58-0.9) at year 3 when ustekinumab was prescribed as the first line treatment. The persistence decrease when ustekinumab was prescribe as a second and third treatment: being 0.53 (0.27-0.73) the first year, 0.46 (0.22-0.67) the second year and 0.46 (0.22-0.67) as a second line treatment and 0.58 (0.44-0.70) the first year, 0.33 (0.17-0.50) the second year and 0.33 (0.17-0.50) the third year as a third line treatment.The persistence was similar to anti-TNF treatment, according to line treatment. Adverse events were mainly mild (97.83%) and occurred the first year of treatment. Most of the adverse events were classified as “infections and infestations” (36.96%).Conclusion:The persistence of ustekinumab was high, being 83% at the end of the first year on treatment and 79% the second and the third year of treatment. The persistence of ustekinumab was higher when if it was the first line treatment compared as if it was used as the second o third BT option. The persistence of Ustekinumab is similar to the persistence of anti-TNF treatments in all the analyzed treatment lines (no statistically differences were found). Adverse events occurred mainly during the first year treatment. They were mainly mild adverse events and the frequency decreased within the second and third year of treatment.References:[1]Treatment with ustekinumab in a Spanish cohort of patients with psoriasis and psoriatic arthritis in daily clinical practice.Almirall M, Rodriguez J, Mateo L, Carrascosa JM, Notario J, Gallardo F. Clin Rheumatol. 2017 Feb;36(2):439-443;[2]Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: results from a 24-week real-world study.Napolitano M, Costa L, Caso F, Megna M, Scarpa R, Balato N, Ayala F, Balato A. J Clin Rheumatol. 2018 Oct;24(7):381-384;[3]Minimal Disease Activity and Patient-Acceptable Symptom State in Psoriatic Arthritis: A Real-World Evidence Study With Ustekinumab.Queiro R, Brandy A, Rosado MC, Lorenzo A, Coto P, Carriles C, Alperi M, Ballina J. Actas Dermosifiliogr. 2018 Jun 28;[4]An analysis of Drug Survival, Effectiveness, and Safety in Moderate to Severe Psoriasis Treated With Ustekinumab: An Observational Study of 69 Patients in Routine Clinical Practice.Salgüero Fernández I, Gil MH, Sanz MS, Gullón GR;Disclosure of Interests:None declared

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Herrero-Morant, A., C. Álvarez-Reguera, L. Sanchez-Bilbao, D. Martínez-López, J. L. Martín-Varillas, G. Suárez-Amorín, R. Fernández Ramón, M. C. Mata Arnaiz, M. Á. González-Gay, and R. Blanco. "POS1346 PREVALENCE, PHENOTYPICAL CLINICAL CLUSTERS AND TREATMENT OF NEUROBEHÇET’S DISEASE. STUDY IN NORTHERN SPAIN." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1011.1–1011. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2671.

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BackgroundBehçet’s disease (BD) may present with different clinical phenotypes. Ocular and Neurobehçet’s Disease (NBD) are severe complications [1-4]. Data on NBD epidemiology, clinical phenotype and therapy are scarce and controversial.ObjectivesIn a wide unselected single-center series of BD our aims were to assess a) NBD prevalence, b) associations with other clinical clusters and c) treatment.MethodsCross-sectional study of all 120 patients diagnosed with BD in Northern Spain, between January 1, 1999 to December 31, 2019. Finally, 96 patients were included in this study according to 2014 International Criteria for Behçet Disease (ICBD) [5]. NBD was diagnosed according to the International Consensus Recommendation (ICR) criteria [4].ResultsNBD was diagnosed in 23 of 96 (24%) patients (15 women/8 men) (mean age: 44±13.9 years). NBD was classified as parenchymatous (n=10, 43.5%), non-parenchymatous (n=10, 43.5%) and mixed (n=3, 13%). HLAB51 was positive in 5 out of 13 (38.4%) patients tested. The main cluster of clinical associations were oral aphthae (n=20, 87%); ocular (n=14, 60.9%), cutaneous (n=10, 43.5%), articular (n=9, 39.1%), vascular (n=4, 17.4%) and intestinal (n=1, 8.7%) involvement (Figure 1).Figure 1.Clusters of clinical associations of NBDTreatments were oral corticosteroids (n=16; 69.6%; mean maximum dose 42±12.5 mg/ day, conventional immunosuppressants (n=13, 56.5%) and Biological Therapy (BT) (n= 7; 30.4%). BT was used in patients who were refractory to conventional immunosuppressants. Monoclonal anti-TNFα were used as the first option in all patients who received BT. In 3 out of 7 (42.7%) patients BT was switched due to inefficacy. Table 1 shows the main NBD clinical subtypes and treatment.Table 1.Main clinical features and treatment of 23 patients with NBDn (%)Mean maximum oral prednisone dose, (SD) mg/dayConventional immunosuppressants, n (%)monoclonal anti-TNFα, n (%)Tocilizumab, n (%)Anakinra, n (%)Parenchymal phenotype10 (43.5)51.7±19.36 (46.2)4 (57.1)00-Hemiparesis5 (50)52.5±7.52 (50)3 (75)-Optic neuropathy-Encephalopathy3 (30)1 (10)52.3±26.3452 (66.7)1 (16.7)00-Ophtalmoparesis1 (10)01 (16.7)1(25)Non-parenchymal phenotype10 (43.5)42±12.55 (38.5)2 (28.6)00-Aseptic meningitis10 (43.5)42±12.55 (38.5)2 (28.6)Mixed3 (13)45±152 (15.4)1(14.3)1 (14.3)1 (14.3)-Aseptic meningitis and ophtalmoparesis1 (33.4)600000-Aseptic meningitis and other cranial nerve involvement1 (33.4)01 (50)000-Encephalopathy and intracranial hypertension1 (33.4)301(50)1(100)1(100)1(100)Complete remission was achieved in 18 of 23 cases (78.2%), partial response in 2 out of 23 cases (8.7%). No severe adverse effects were observed.ConclusionNBD was observed in 24% of patients with BD. The most frequent clinical clusters of NBD were oral aphthae and ocular involvement. All patients treated with either conventional immunosuppressant or BT achieved clinical remission.References[1]Martín-Varillas JL, et al. Ophthalmology 2018 Sep;125(9):1444-1451. doi: 10.1016/j.ophtha.2018.02.020.[2]Atienza-Mateo B, et al. Arthritis Rheumatol 2019 Dec;71(12):2081-2089. doi: 10.1002/art.41026.[3]Santos-Gómez M, et al. Clin Exp Rheumatol 2016 Sep-Oct;34(6 Suppl 102): S34-S40.[4]Kalra S, et al. Diagnosis and management of Neuro-Behçet’s disease: international consensus recommendations. J Neurol. 2014 Sep;261(9):1662–76.[5]International Team for the Revision of the International Criteria for Behçet’s Disease (ITR-ICBD). J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47.Disclosure of InterestsAlba Herrero-Morant: None declared, Carmen Álvarez-Reguera: None declared, Lara Sanchez-Bilbao: None declared, David Martínez-López: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Lilly, Janssen, UCB, and Celgene, Guillermo Suárez-Amorín: None declared, Raúl Fernández Ramón: None declared, M. Cristina Mata Arnaiz: None declared, Miguel Á. González-Gay Speakers bureau: Abbvie, Roche, Sanofi, Lilly, Celgene, Sobi, and MSD, Grant/research support from: Abbvie, MSD, Janssen, and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, BMS, Janssen, and MSD, Grant/research support from: Abbvie, MSD, and Roche

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Engel, T., E. Dotan, S. Ben-Horin, and U. Kopylov. "DOP60 Self-reported treatment effectiveness for Crohn’s Disease using a novel crowdsourcing web-based platform." Journal of Crohn's and Colitis 16, Supplement_1 (January 1, 2022): i106—i107. http://dx.doi.org/10.1093/ecco-jcc/jjab232.099.

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Abstract Background The world wide web and social media platforms have become an unprecedented source for sharing self-experience, potentially allowing the collection and integration of health data with patient experience Methods StuffThatWorks (STW) is an online open platform that applies machine learning and the power of crowdsourcing where patients with chronic medical conditions can self-report and compare their individual outcomes using a structured online questionnaire. The present study analyzed de-identified self-reported personalized comparative treatments’ effectiveness for CD. The design was a cross-sectional, international, crowdsourcing, questionnaire and AI web-based study of patients with Crohn’s self-reporting their outcomes by 06/11/21. A proprietary STW Bayesian inference model was built to measures the level of improvement in condition severity and clinical indicators for each treatment and ranks treatment effectiveness. A linear regression model was used to examine co-variate association with the current condition severity as the outcome. Finally, the effectiveness of first-line biological treatments was analyzed by multiple treatment comparisons model and by calculating odds ratio and 95% confidence intervals for each treatment pair. Results A total of 5898 self-reported CD patients were included for the analysis. Most participants were female (76.13%) and from English speaking countries (91%). Overall, anti TNF drugs were the most reported tried treatment (71.97%) followed by steroids (46.22%) and diet (43.8%). Among Biologic therapy (BT) tried by STW CD users, Infliximab (IFX) and Adalimumab (ADA) were ranked most effective by the STW effectiveness model, by change in condition severity on 1–5 scale (mean change of 1.19 points, estimated lower-upper bounds 1.10–1.28), followed by Ustekinumab (UST) (mean 1.07, bounds 0.88–1.26), and Vedolizumab (VDZ) (mean 0.96, bounds 0.74–1.17). Bowel surgery (mean 1.19, bounds 0.98–1.40), and cannabis (mean 1.01, bounds 0.72–1.31) were also among the top 5 most effective treatments together with BT. The odds ratio was calculated for each BT pair, with IFX more effective than ADA, UST and VDZ (OR 2.34 (CI 1.88 – 2.80), 3.08 (CI 2.44 – 3,73), 7.16 (CI 6.53 – 7.80), respectively), ADA more effective than UST and VDZ (OR 1.32 (CI 0.74 - 1.9), 3.06 (CI 2.49 - 3.63), respectively), and UST more effective than VDZ (OR 2.32 (CI 1.6 - 3.05)). Conclusion We present the first online crowdsourcing platform-based study of treatment self-reported outcomes in CD. Net-based crowdsourcing patient-reported outcomes’ platforms can potentially help both clinicians and patients select the best treatment for their condition.

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Ivankova, V. S., V. M. Mikhailenko, E. A. Domina, T. V. Khrulenko, L. M. Baranovska, and O. O. Hrinchenko. "Therapeutic irradiation in the management of gynecological cancer and predictability of radiation-induced complications." Український радіологічний та онкологічний журнал 29, no. 2 (June 9, 2021): 34–51. http://dx.doi.org/10.46879/ukroj.2.2021.34-51.

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Background. Today, applying radiotherapy (RT) in management of both primary and secondary vaginal cancer (SVC) take pride of place in the spectrum of specialized treatments for cancer patients. Secondary vaginal tumors are more common (6% to 33%) in cervical cancer (CC) patients, while in uterine cancer (UC) occur in 8–10% of cases treated either surgically, or by means of radiotherapy, otherwise via a combination approach. Therefore, RT is administered in about 80% of primary vaginal cancer and particularly SVC patients. When using even the most advanced radiotherapy equipment implying the cutting-edge technologies, there is a risk of radiation-induced complications in healthy organs and tissues that fall under the irradiation area. Keeping in mind the key radiobiological paradigms makes it possible not only to predict the probability of tumor resorption upon radiation exposure, but also to assess the biological effectiveness of absorbed dose, as well as the risk of late radiation complications. Purpose – to enhance the effectiveness and assess the toxicity of SVC RT via ascertaining BT (brachytherapy) most suitable techniques depending on the type of ionizing radiation and exploring predictability of radiation-induced complications in terms of biomolecular cell properties. Materials and methods. Clinical study was performed at the National Cancer Institute Clinic (Radiation Oncology Department), using a high-energy BT unit with a HDR 192Ir source. The SVC patients (n = 106) were treated according to the developed BT methods. They had been pretreated for the CC (n = 65) with squamous cell carcinoma histologically diagnosed in the most cases or UC (n = 41) with histologically prevalent adenocarcinoma of a variable grade. Patients had a locally advanced pelvic tumor process with tumor staging II–III, T2-3N0-1M0. Along with clinical study the radiobiological research was conducted to count the apoptotic cells in both intact and irradiated peripheral blood lymphocytes (PBL), as well as the level of SH-groups of plasma proteins and peptides in gynecological cancer patients and healthy donors to predict the risk of radiation-induced complications. Results and discussion. Given the delayed effect of RT, the treatment effective- ness was analyzed immediately after RT session and also 3 months upon completion of the conservative therapy. Thus, positive tumor response upon three months of observation over time was registered in 67.9 ± 5.2% of patients in study group I, in 72.5 ± 6.9% in study group II, and in 51.3 ± 6.8% in comparison group. Hence the values in study groups were higher than in comparison group by 16.6% and 21.2% respectively. All patients tolerated BT satisfactorily. Neither general nor local rectum or bladder severe (above grade II) toxicities were noted both during treatment and over the next 3 months upon its completion in all the patients regardless of study group. Results obtained in radiobiological studies correlated with clinical and literature data. Conclusions. Decrease in manifestations of RT toxicity, namely of the ear- ly radiation reactions from interfacing critical organs was established in groups I and II vs comparison group I, especially in group I where a high- energy 192Ir source was used in the SBD irradiation mode of 3 Gy twice a week. The obtained results of the experimental study suggest that the content of SH-groups in blood plasma and the level of PBL apoptosis can be considered as additional predictive measures of radiosensitivity of non-malignant cells from the irradiated tumor environment.

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Nuñez-Olvera, Stephanie I., Lorena Aguilar-Arnal, Mireya Cisneros-Villanueva, Alfredo Hidalgo-Miranda, Laurence A. Marchat, Yarely M. Salinas-Vera, Rosalio Ramos-Payán, et al. "Breast Cancer Cells Reprogram the Oncogenic lncRNAs/mRNAs Coexpression Networks in Three-Dimensional Microenvironment." Cells 11, no. 21 (November 1, 2022): 3458. http://dx.doi.org/10.3390/cells11213458.

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Organotypic three-dimensional (3D) cell cultures more accurately mimic the characteristics of solid tumors in vivo in comparison with traditional two-dimensional (2D) monolayer cell models. Currently, studies on the regulation of long non-coding RNAs (lncRNAs) have not been explored in breast cancer cells cultured in 3D microenvironments. In the present research, we studied the expression and potential roles of lncRNAs in estrogen receptor-positive luminal B subtype BT-474 breast cancer cells grown over extracellular matrix proteins-enriched 3D cultures. Global expression profiling using DNA microarrays identifies 290 upregulated and 183 downregulated lncRNAs in 3D cultures relative to 2D condition. Using a co-expression analysis approach of lncRNAs and mRNAs pairs expressed in the same experimental conditions, we identify hundreds of regulatory axes modulating genes involved in cancer hallmarks, such as responses to estrogens, cell proliferation, hypoxia, apical junctions, and resistance to endocrine therapy. In addition, we identified 102 lncRNAs/mRNA correlations in 3D cultures, which were similar to those reported in TCGA datasets obtained from luminal B breast cancer patients. Interestingly, we also found a set of mRNAs transcripts co-expressed with LINC00847 and CTD-2566J3.1 lncRNAs, which were predictors of pathologic complete response and overall survival. Finally, both LINC00847 and CTD -2566J3.1 were co-expressed with essential genes for cancer genetic dependencies, such as FOXA1 y GINS2. Our experimental and predictive findings show that co-expressed lncRNAs/mRNAs pairs exhibit a high degree of similarity with those found in luminal B breast cancer patients, suggesting that they could be adequate pre-clinical tools to identify not only biomarkers related to endocrine therapy response and PCR, but to understand the biological behavior of cancer cells in 3D microenvironments.

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Cuker, Adam, Beverly Ptashkin, Barbara A. Konkle, Steven W. Pipe, Herbert C. Whinna, X. Long Zheng, Douglas B. Cines, and Eleanor Pollak. "Interlaboratory Precision in the Monitoring of Unfractionated Heparin Using the Anti-Factor Xa-Correlated Activated Partial Thromboplastin Time." Blood 112, no. 11 (November 16, 2008): 435. http://dx.doi.org/10.1182/blood.v112.11.435.435.

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Abstract Although the activated partial thromboplastin time (aPTT) remains the most widely used method for monitoring unfractionated heparin (UFH) therapy, it is affected by a number of preanalytic, analytic, and biological variables, which undermine both its accuracy and precision. In an effort to improve the accuracy and precision of laboratory monitoring of UFH, the College of American Pathologists (CAP) and the American College of Chest Physicians (ACCP) have issued guidelines recommending that the therapeutic range of the aPTT be defined in each laboratory through correlation with a direct measurement of heparin activity such as the factor Xa inhibition assay (anti-FXa). Whether and to what extent this approach enhances the precision of UFH monitoring has not been reported. We conducted a cross-validation study among 4 CAP-accredited coagulation laboratories to assess the interlaboratory precision of the anti-FXa-correlation method. An aPTT and anti-FXa were performed in each laboratory on plasma samples from 44 inpatients receiving UFH. Interlaboratory precision of the anti-FXa-correlation method was compared to that of the traditional 1.5–2.5 times the upper limit of normal (ULN) method for defining the therapeutic aPTT range. Modest to poor intralaboratory correlation between the aPTT and anti-FXa was observed in each of the 4 laboratories. The coefficients of determination (R2) ranged from 0.1962 to 0.6964. In accordance with CAP guidelines, the anti-FXa-derived therapeutic aPTT range was defined by linear regression corresponding to a range of anti-FXa activity of 0.3 – 0.7 units/ml. In each laboratory, the range defined by this method was broader than that defined using the ULN method. In 3 of the laboratories, the therapeutic range defined by the anti-FXa-correlation method extended more than 20 seconds beyond the upper limit of the therapeutic range defined by the ULN approach. Based on the laboratory-specific therapeutic ranges defined by both methods, samples were segregated into therapeutic category [i.e. below therapeutic (BT), therapeutic (T), or above therapeutic (AT)]. Using the ULN method, there was agreement among all 4 laboratories regarding the therapeutic category in 22 (50%) samples, whereas consensus was achieved in only 7 (16%) samples with the anti-FXa-correlation method. Furthermore, 3 (7%) samples were simultaneously determined to be BT and AT in different laboratories by the anti-FXa-correlation method, suggesting that the dose of UFH might be increased in one center and decreased in another for the same patient encounter. This striking discrepancy was not observed with the ULN method. In conclusion, the anti-FXa-correlation method for defining the therapeutic range of the aPTT does not enhance the interlaboratory precision of UFH laboratory monitoring and may be inferior to the ULN method in this regard. Clinical studies are needed to assess the impact of these findings on patient safety.

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Shahabaz, Amir, and Muhammad Afzal. "Implementation of High Dose Rate Brachytherapy in Cancer Treatment." Science Progress and Research 1, no. 3 (June 11, 2021): 77–106. http://dx.doi.org/10.52152/spr/2021.121.

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A technique of radiation therapy delivery in which the radioactive sources are placed very close or even inside the target volume is called Brachytherapy (BT). Brachytherapy is a type of radiation therapy. It destroys cancer cells by making it hard for them to multiply. In this technique, a radiation source is placed directly into or near a tumour. High dose-rate brachytherapy is also known as HDR brachytherapy, or temporary brachytherapy. It is a type of internal radiotherapy. HDR was developed to reduce the risk of cancer recurrence while shortening the amount of time it takes to get radiation treatment. HDR also limits the dose of radiation (associated side effects) to surrounding normal tissue. The important benefits of HDR brachytherapy include extremely precise radiation therapy delivered internally, used alone or after surgery to help prevent cancer recurrence, convenient treatments that are usually pain-free, and a reduction in the risk of common short- and long-term side effects. Currently, tumour dose, as well as doses of the surrounding normal structures, can be evaluated accurately, and high-dose-rate brachytherapy enables three-dimensional image guidance. The biological disadvantages of high-dose-rate were overcome by fractional irradiation. In the definitive radiation therapy of cervical cancer, high-dose-rate brachytherapy is most necessary. Most patients feel little discomfort during brachytherapy. There is no residual radioactivity when the treatment is completed. A patient may be able to go home shortly after the procedure, resuming his normal activities with few restrictions. An advantage of brachytherapy is to deliver a high dose to the tumour during treatment and save the surrounding normal tissues. High-dose-rate (HDR) brachytherapy has great promise with respect to proper case selection and delivery technique because it eliminates radiation exposure, can be performed on an outpatient basis and allows short treatment times. Additionally, by varying the dwell time at each dwell position, the use of a single-stepping source allows optimization of dose distribution. As the short treatment times do not allow any time for correction of errors, and mistakes can result in harm to patients, so the treatments must be executed carefully by using HDR brachytherapy. Refinements will occur primarily in the integration of imaging (computed tomography, magnetic resonance imaging, intraoperative ultrasonography) and optimization of dose distribution and it is expected that the use of HDR brachytherapy will greatly expand over the next decade. Various factors in the development of well-controlled randomized trials addressing issues of efficacy, quality of life, toxicity and costs-versus-benefits will ultimately define the role of HDR brachytherapy in the therapeutic armamentarium. Surrounding healthy tissues are not affected by the radiation due to the ability to target radiation therapy at high dose rates directly to the tumour. Treatment to be delivered as an outpatient in as few as one to five sessions is also allowed by this targeted high dose approach. HDR brachytherapy is the most precision radiation therapy, even better than carbon ion therapy. At the time of invasive placement of the radiation source into the tumour area, brachytherapy requires the skills and techniques of radiation oncologists.

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Alvarez Reguera, C., D. Martínez-López, L. Sanchez Bilbao, A. Herrero Morant, J. L. Martín-Varillas, G. Suárez Amorín, P. Setien Preciados, M. C. Mata Arnaiz, M. Á. González-Gay, and R. Blanco. "AB0458 SYSTEMIC TREATMENT IN BEHÇET’S DISEASE ACCORDING TO CLINICAL PHENOTYPES. STUDY OF 111 PATIENTS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1527.2–1528. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5005.

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Background:Behçet’s disease (BD) is a multisystemic vasculitis. Different clinical phenotypes can be distinguished. Systemic corticosteroids are the most used drugs in BD. Conventional and biological immunosuppressants (IS) may also be used.Objectives:To evaluate the systemic treatment of BD according to clinical domains.Methods:Study of all consecutive 111 patients diagnosed with definitive or possible BD by expert rheumatologists in a well-defined population of Northern Spain, between 1980 and 2019. Most of them met the International Criteria for BD (ICBD) (1).Results:We studied 111 patients (62 women/49 men), mean age at diagnosis 36.8±13.2 years. After a mean follow-up of 81.4±85 months, all patients required systemic treatment (TABLE 1-2).Biological therapy (n=28) was indicated by ocular manifestations (n=13; 46.4%) persistent, severe and refractory oral ulcers (n=10, 35.7%), neurological (n=2; 7.1%), musculoskeletal (n=2; 7.1%) or cutaneous involvement (1; 3.6%). Adalimumab and Infliximab were the biological therapy more frequently used.TABLE.CLÍNICALPHENOTYPESCases N (%)COLCHCOSDosis total ISAZAMTXCYAMMFTLDAPRDAPOral ulcers110 (99.1)85 (77.9)81 (73.6)51 (46.4)30 (27.3)25 (22.7)14 (12.7)2 (1.8)6 (5.5)6 (5.5)3 (2.7)Genital ulcers69 (62.2)56 (81.2)51 (74)32 (46.4)17 (24.6)16 (23.2)10 (14.5)1 (1.5)5 (7.2)2 (3.4)3 (4.3)Cutaneous lesions76 (68.5)58 (76.3)61 (80.3)52 (68.4)32 (42.1)22 (29)9 (11.8)05 (6.6)6 (7.9)3 (4)Ocular manifestations39 (35.1)27 (69.2)36 (92.3)19 (48.7)17 (43.6)12 (30.8)11 (28.2)2 (5.1)4 (10.3)2 (5.1)2 (5.1)Neurological involvement20 (18)12 (60)15 (75)15 (75)3 (15)4 (20)3 (15)1 (5)001 (5)Vascular manifestations11 (10)8 (72.7)9 (81.8)5 (45.5)3 (27.3)3 (27.3)1 (9.1)0000Gastrointestinal involvement4 (3.6)2 (50)1 (25)1 (25)1 (25)000000TOTAL11185 (76.6)85 (76.6)51 (46)30 (27)25 (22.5)14 (12.6)2 (1.8)6 (5.4)6 (5.4)3 (2.7)Conclusion:Most patients with BD required oral corticosteroids and colchicine. Almost half required conventional IS. Up to a third required biologic therapy, especially by ocular involvement. Most patients had clinical improvement.References:[1]Criteria for diagnosis of Behcet’s disease, International Study Group for Behçet’s Disease,The Lancet, Volume 335, Issue 8697, 1078 – 1080TABLE 2.CLINICALPHENOTYPESBTADAIFXETNTCZNo improvementPartial improvementComplete responseOral ulcers28 (35.5)22 (20)12 (11)3 (2.7)2 (1.8)22 (20)22 (20)66 (60)Genital ulcers17 (24.7)13 (18.8)8 (11.6)2 (2.9)1 (1.4)16 (23.2)12 (17.4)41 (59.4)Cutaneous lesions21 (27.6)18 (23.7)8 (10.5)3 (4)2 (2.6)8 (10.5)19 (25)49 (64.5)Ocular manifestations19 (50)16 (42.1)9 (23.7)1 (2.6)2 (5.3)08(21)30 (79)Neurological involvement7 (35)2 (10)4 (20)1 (5)03 (15)5 (25)12 (60)Vascular manifestations4 (36.4)3 (27.3)2 (18.2)1 (9.1)1 (9.1)2 (18.2)4(36.4)5 (45.5)Gastrointestinal involvement000001 (25)1 (25)2 (50)TOTAL28 (25.2)22 (19.8)12 (10.8)3 (2.7)2 (1.8)22 (19.8)22 (19.8)67 (60.4)Abbreviations: COLCH: Colchicine; OCS: Oral Corticosteroids; IS: Immunosuppressants; AZA: Azathioprine; MTX: Methotrexate; CYA: Cyclosporine A; MMF: Mycophenolate Mofetil; TLD: Talidomide; APR: Apremilast; DAP: Dapsone; BT: Biologic Therapy; ADA: Adalimumab; IFX: Infliximab; ETN: Etanercept; TCZ: TocilizumabDisclosure of Interests:Carmen Alvarez Reguera: None declared, David Martínez-López: None declared, Lara Sanchez Bilbao: None declared, Alba Herrero Morant: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Guillermo Suárez Amorín: None declared, Patricia Setien Preciados: None declared, M. Cristina Mata Arnaiz: None declared, Miguel Á. González-Gay Grant/research support from: AbbVie, MSD and Roche, Speakers bureau: AbbVie, MSD and Roche, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant of: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD

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Pontikaki, I., E. G. Favalli, M. Biggioggero, F. Rovelli, A. Becciolini, M. Gattinara, P. L. Meroni, and V. Gerloni. "THU0171 Which Adverse Events (AES) of Biological Therapy (BT) Led to Discontinuation of Treatment in A Cohort of 377 JIA Patients in Comparison to 1115 Patients Affected by Ra, As, PSA in the Department of Rheumatology of G. Pini Institute." Annals of the Rheumatic Diseases 73, Suppl 2 (June 2014): 239.3–240. http://dx.doi.org/10.1136/annrheumdis-2014-eular.5738.

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Galindez, E., D. Prieto-Peña, J. L. Martín-Varillas, B. Joven-Ibáñez, O. Rusinovich, R. Almodovar, J. J. Alegre-Sancho, et al. "AB0768 TREATMENT WITH TOFACITINIB IN REFRACTORY PSORIATIC ARTHRITIS. MULTICENTER STUDY OF 87 PATIENTS IN CLINICAL PRACTICE." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1682.1–1682. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2903.

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Background:Tofacitinib (TOFA) is the first JAKi approved for psoriatic arthritis (PsA) in Europe (July 2018). TOFA has shown efficacy in refractory patients to anti-TNF in Randomized Clinical Trials (RCT) (Gladman D. NEJM 2017; 377: 1525-36).Objectives:To assess efficacy and safety of TOFA in clinical practice (CP). To compare the profile of CP with RCTMethods:Study of 87 patients of CP with PsA treated with TOFA; Results are expressed as percentage, mean±SD or median [IRQ].Results:87 patients (28♀/59♂), mean age of 52.8±11.4 years (Table 1). Pattern of joint involvement was: peripheral (n=60), axial (1) and mixed (26). Presented also enthesitis (49.4%), nail involvement (30.2%) and dactylitis (31%).Prior TOFA, most patients (80%) received oral prednisone, synthetic immunosuppressants (mean 2.3±0.9) and biological therapy (BT) (3.6±1.9): etanercept (n=58), adalimumab (54), infliximab (31), golimumab (37), certolizumab (30), secukinumab (54), ustekinumab (39) and ixekizumab (2). Apremilast was used in 17.After a mean follow-up of 12.3±9.3 years from PsA diagnosis, TOFA was started (5 mg/12 h). In 48 (55.2%) TOFA was used in combined therapy: methotrexate (30) and leflunomide (15). In the remaining 39, monotherapy was prescribed.Patients of CP compared with RCT have a longer duration of PsA, worst functional disability (HAQ) and received a higher proportion of corticosteroids and BT (anti-TNF and non-anti-TNF) (Table 1).Patients improved in activity indexes (PASI, DAS28, DAPSA) and laboratory test (table 2). Minor side effects were reported in 21 patients (gastrointestinal symptoms), and TOFA was discontinued in 29 due to inefficiency mainly.Conclusion:Patients of CP had a longer evolution and received a greater number of biologics than those of RCT. TOFA as in RCT seems effective, rapid and relatively safe for refractory PsA.Table 1.Baseline featuresCLINICAL TRIALGladmanN=131CLINICAL PRACTICEN=87Age, years (mean±SD)49.5±12.352.8±11.4Sex, n (%)67M/64F (51/49)59M/28F (68/32.2)Duration PsA, years (mean±SD)9.6±7.612,3±9.3HAQ-DI1.3±0.71.4±0.7 (n=26)Swollen joint count, mean±SD12.1±10.65.7±5.8Painful joint count, mean±SD20.5±13.08.0±6.6Elevated CRP, n (%)85 (65)55 (63.2)PASI score, median [IQR]7.6 [0.6-32.2]9.0 [4.2-15]Oral glucocorticoid, n (%)37(28)44(50.5)Concomitant synthetic DMARDs, n (%)- Methotrexate98 (75)30 (34.4)- Leflunomide12 (9)15 (17.2)- Sulfasalazine21 (16)6 (6.9)- Others2 (2)N. of previous TNF inhibitors, mean±SD1.7±1.02.4±1.4Previous use of other biological no anti-TNF, n (%)11 (8)68 (78.2)Table 2.Table 2. Improvement at 1st, 6thand 12thmonthBaselinen=871st monthn=776th monthn=5212th monthn=20Nail involvement, n (%)17 (19.5)Improvement, n (%)5 (35.7)6 (60)5 (83.3)Enthesitis, n (%)28 (32.2)Improvement, n (%)8 (47.1)10 (58.8)3 (50)Dactylitis, n (%)16 (18.4)Improvement, n (%)9 (69.2)6 (85.7)0 (0)CRP mg/dl, median [IQR]1.9 [0.3-5]0.5 [0.1-2.2]0.5 [0.3-1.2]0.4 [0.4-3.7]p (vs baseline)0.0040.0050.66DAS28, median [IQR]4.8 [4.1-5.403.7 [2.8-4.6]2.8 [2.2-3.8]2.9 [2.2-3.7]p (vs baseline)<0.001<0.001<0.001DAPSA, median [IQR]28 [18.41-34.05]15.5 [10.1-25.7]9 [6.07-15]4.3 [2.4-8]p (vs baseline)<0.001<0.001<0.001PASI, median [IQR]5 [1-14]1.4 [0-7]0 [0-4]0.05 [0-2.7]p (vs baseline)0.1920.1050.300Disclosure of Interests:E. Galindez: None declared, D. Prieto-Peña: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Olga Rusinovich: None declared, RAQUEL ALMODOVAR Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer., Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis, LARA MENDEZ DIAZ: None declared, Agusti Sellas-Fernández Speakers bureau: Abbott, Lilly, Celgene, Pfizer, Schering-Plough, Janssen, Novartis, and Nordic Pharma, À Martínez-Ferrer: None declared, Rosario Garcia de Vicuna Grant/research support from: BMS, Lilly, MSD, Novartis, Roche, Consultant of: Abbvie, Biogen, BMS, Celltrion, Gebro, Lilly, Mylan, Pfizer, Sandoz, Sanofi, Paid instructor for: Lilly, Speakers bureau: BMS, Lilly, Pfizer, Sandoz, Sanofi, Clara Ventín-Rodríguez: None declared, Julio Ramirez: None declared, Manuel Moreno: None declared, Maria jose Moreno: None declared, María del Carmen Castro Villegas: None declared, Antia Crespo Golmar: None declared, Natalia Palmou-Fontana: None declared, FRANCISCO ORTIZ SANJUAN: None declared, Ximena Elizabeth Larco Rojas: None declared, Antonio Juan Mas: None declared, Christian Y Soleto: None declared, Iñigo Gorostiza: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

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Álvarez, Isabel, Ángel Guerrero-Zotano, Josefina Cruz, Purificación Martínez, María Hernández, César A. Rodríguez, Álvaro Rodríguez-Lescure, et al. "Abstract P1-15-04: Features of HER2+ metastasic patients (pts) from a prospective registry of advanced breast cancer (ABC), GEICAM/2014-03 (RegistEM)." Cancer Research 82, no. 4_Supplement (February 15, 2022): P1–15–04—P1–15–04. http://dx.doi.org/10.1158/1538-7445.sabcs21-p1-15-04.

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Abstract Background: The RegistEM study is a non-interventional study that is providing prospective data from around 1900 ABC pts (females and males) diagnosed with advanced disease between 01/Jan/2016 and 31/Dec/2019, either after recurrence or at 1st diagnosis, in 38 Spanish sites representative of the national territory and whose investigators are GEICAM members. Methods: In the current analysis (cut-off date 10/May/2021, ongoing database), we describe the features of 279 pts included in the RegistEM study, with HER2+ (immunohistochemistry [IHQ] 3+, IHQ 2+ and in situ hybridization [ISH]+) tumors at any time of their ABC (5% after the 1st-line therapy). This subgroup has been evaluated because of the interest from a clinical perspective. Multivariate Cox analysis aiming to identify factors associated with overall survival (OS) were built. Results: 279 pts were identified, representing the 15% pts available in the database at the cut-off date. At first ABC diagnosis, 48% pts had recurrent BC (>12 months [mo] from initial BC diagnosis in 93%), 51% de novo metastatic BC and 1% unresectable locally advanced BC (ULABC). The median age was 59 years, 98% were white , 71% postmenopausal and only 1 male was part of this subset. Considering the BC subtype assessed in the most recent tumor lesion before the 1st-line therapy, 264 pts wereHER2 positive (67% with hormone receptor [HR]+). Family history of BC and/or ovarian cancer was reported in 31% pts, and an hereditary-risk genetic test was performed in 25% (66/267 pts). BRCA1/2 and TP53 mutations were reported in 4/20 and 4/19 pts, respectively, and p53 overexpression in 20/46 pts. Lymph nodes (56%), bone (49%), liver (34%), lung (33%), soft tissue (10%) and brain (8%) were the main metastatic sites. Additional data according to HR status and type of ABC are detailed in the table below. In HR- pts, bone metastases were less frequent and lymph nodes metastases more frequent compared to HR+ pts. Visceral disease was present in 68% pts and ≈75% had ≤3 (47% ≤2) locations involved. The most common therapies by line were: 1) 1st-line: CT + dual anti-HER2 blockade (3%), chemotherapy (CT) (almost in all pts taxane-based)+dual anti-HER2 blockade + endocrine therapy (ET) (mainly aromatase inhibitors) (35%), and ET + anti-HER2 blockade or ET + cyclin-dependent kinases 4/6 inhibitors (11%); 2) 2nd-line: anti-HER2 blockade (56%) [mostly an antibody-drug conjugate (90%)], CT + anti-HER2 blockade (18%) and ET + anti-HER2 blockade (14%); 3) 3rd-line: CT + anti-HER2 blockade (55%) and anti-HER2 blockade (22%). The median time-to-progressions to 1st-, 2nd- and 3rd-line were 14, 5, and 4 mo, respectively. A 4th-line therapy was reported in 52% of pts who received a 3rd-line. At database cut-off date, death was reported in 34% of pts. The median OS of this subset of pts was 41 mo (36-49). In a multivariate Cox regression analysis, the following variables were significantly related with worse survival (from ABC diagnosis): Brain (HR=2.62; 95% CI, 1.02-6.73) and Visceral no Brain involvement (HR=2.15; 95% CI, 1.02-4.53) compare to only soft tissue lesions; early stage at first diagnosis (HR=1.77; 95% CI, 1.15-2.73); HR- (HR=1.70; 95% CI, 1.11-2.60) and age (HR=1.04; 95% CI, 1.02-1.07). Conclusions: In this cohort of HER2+ pts with advanced disease, half of them had de novo ABC which was associated with better OS. The median PFS in 1st- and 3rd-line were slightly better in HR+ pts, and in 2nd-line was similar between HR+ and HR- cohorts. HR+181 (67%)HR- 91 (33%)Recurrent EBC134 (48%)ULABC or de novo M1 145 (52%)Time to recurrence >12 mo in EBC pts., n8435125NALocation of metastaticsites, nBoneBrainLiverLungLymph nodesSoft tissue104 10 62 57 90 1829 9 3232 64 1059 15 36 47 51 2278 6 59 46 1056Líne123123123123n180935690492613385521446333Deaths, n211112111161715141584Therapies by line, nET/BT261922101910212100ET12441011022323CT/BT/ET935031038305830CT/BT4017307581552182366924CT3572353711211BT6431373651145143385The most frequent therapies, nCT + dual anti-HER2 blockade + ET8623331551CT + single-agent HER2 blockade + ET522CT + dual anti-HER2 blockade3493644391016252CT + single-agent HER2 blockade4825641588211521CT5573354711411ET*22105212162644ET + HER2 blockade1213411662782Anti-HER2 blockade6431073651145143382Median duration of treatment, mo125585310441064TTP (mo), median (range)15(1-47)5(1-32)5(0-18)11(2-38)5(1-27)4(2-12)12 (1-47)5(1-26)4(0-17)17(2-45)7(1-32)4(1-18)Median PFS, mo14561154------HR: hormone receptor; EBC: early breast cancer; ULABC: unresectable locally advanced breast cancer; M1: metastatic; mo: month; ET: endrocrine therapy; BT: biological therapy; CT: chemotherapy; TTP: time-to-progression; PFS: progression-free survival. *ET includes aromatase inhibitors or selective estrogen receptor degraders, as single-agents or combined with cyclin-dependent kinases 4/6 inhibitors. Citation Format: Isabel Álvarez, Ángel Guerrero-Zotano, Josefina Cruz, Purificación Martínez, María Hernández, César A Rodríguez, Álvaro Rodríguez-Lescure, Silvia Antolín, Encarna Adrover, Raquel Andrés, Catalina Falo, Jose Ignacio Chacón, Ana Miguel, Sonia Servitja, Maria Galán Gramaje, Mireia Margelí Vila, César Gómez Raposo, María Jose Echarri, Rafael Villanueva, Ariadna TIbau Martorell, Silvia Varela Ferreiro, Ruth Campo, Juan Jose Miralles, Susana Bezares, Federico Rojo, Sara López-Tarruella. Features of HER2+ metastasic patients (pts) from a prospective registry of advanced breast cancer (ABC), GEICAM/2014-03 (RegistEM) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-15-04.

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Journal articles on the topic 'Biological therapy (BT)'

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