Tumor Necrosis Factor Inhibitor Monotherapy Versus Combination Therapy for the Treatment of Psoriatic Arthritis: Combined Analysis of European Biologics Databases.

OBJECTIVE: To investigate whether tumor necrosis factor inhibitor (TNFi) combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) is more effective for psoriatic arthritis (PsA) and/or improves TNFi drug survival compared to TNFi monotherapy. METHODS: Five PsA biologics cohorts were investigated between 2000 and 2015: the ATTRA registry (Czech Republic); the Swiss Clinical Quality Management PsA registry; the Hellenic Registry of Biologics Therapies (Greece); the University of Bari PsA biologics database (Italy); and the Bath PsA cohort (UK). Drug persistence was analyzed using Kaplan-Meier and equality of survival using log-rank tests. Comparative effectiveness was investigated using logistic regression with propensity scores. Separate analyses were performed on (1) the combined Italian/Swiss cohorts for change in rate of Disease Activity Score in 28 joints (DAS28); and (2) the combined Italian, Swiss, and Bath cohorts for change in rate of Health Assessment Questionnaire (HAQ). RESULTS: In total, 2294 patients were eligible for the drug survival analysis. In the Swiss (P = 0.002), Greek (P = 0.021), and Bath (P = 0.014) databases, patients starting TNFi in combination with methotrexate had longer drug survival compared to monotherapy, while in Italy the monotherapy group persisted longer (P = 0.030). In eligible patients from the combined Italian/Swiss dataset (n = 1056), there was no significant difference between treatment arms in rate of change of DAS28. Similarly, when also including the Bath cohort (n = 1205), there was no significant difference in rate of change of HAQ. CONCLUSION: Combination therapy of a TNFi with a csDMARD does not appear to affect improvement of disease activity or HAQ versus TNFi monotherapy, but it may improve TNFi drug survival.

Longterm Clinical Outcomes in 420 Patients with Psoriatic Arthritis Taking Anti-tumor Necrosis Factor Drugs in Real-world Settings.

OBJECTIVE: An observational study to evaluate the longterm clinical outcomes of adalimumab (ADA), etanercept (ETN), and infliximab (IFX) in patients with psoriatic arthritis (PsA), in real-world settings. METHODS: From a prospective cohort we studied 420 biologic-naive patients with PsA who had peripheral arthritis and were beginning a treatment with ADA, ETN, or IFX. Drug survival was evaluated by Kaplan-Meier life analysis, and baseline predictors of drug discontinuation were assessed by Cox regression analysis. The frequency of concomitant glucocorticoids and the daily mean dosage were compared by chi-square test and ANOVA repeated measures across 4 years. RESULTS: After 4 years the overall survival of the first anti-tumor necrosis factor-α (anti-TNF) was 51.0%, but significantly higher for ETN (58.9%) than ADA (43.9%) or IFX (44.0%; p = 0.003). Patients taking ETN also had the lowest HR of drug discontinuation (HR 0.57, 95% CI 0.34-0.93, p = 0.02). The strongest predictor of drug interruption was female sex (HR 2.02, 95% CI 1.28-3.20, p = 0.002). The disease duration was inversely correlated with drug discontinuation (HR 0.96, 95% CI 0.93-0.99, p = 0.02). The average daily dose of prednisone significantly decreased from baseline: 5.6 ± 2.5 to 4.7 ± 1.9 at 1 year (p = 0.01) to 4.0 ± 1.8 at 4 years (p = 0.001). Additionally, compared to baseline (49.6%), a significant reduction of patients taking glucocorticoids was detected at 2 years (36.5%, p < 0.05), 3 years (29.9%, p < 0.01), and 4 years (22.6%, p < 0.01). CONCLUSION: In real-world settings, TNF inhibitors showed a high rate of drug survival at 4 years. Further, the need for glucocorticoids for controlling active PsA was lowered with time.

Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register.

INTRODUCTION: Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX). OBJECTIVES: To evaluate the efficacy and safety of RTX-MTX combination therapy compared with RTX alone in the treatment of RA. METHODS: We analyzed data from a prospective cohort study, the Italian biologic register GISEA, to investigate the efficacy and safety of rituximab. Moreover, the adverse events (AE) and the causes of discontinuation therapy were analyzed. RESULTS: We identified 338 RA patients, 162 treated with RTX and 176 with RTX-MTX. After 52 and 104 weeks of therapy the disease activity score in 28 joints and the Health Assessment Questionnaire Score were available in 168 patients (78 with RTX-MTX and 60 with RTX alone), showing significant reduction without differences among the two groups. AE were reported in 142 patients (42%), for a total of 368 recorded side effects. The majority (90.5%) of AE were mild to moderate in severity. Comparable percentages of severe AE were reported in the 2 groups (9.9% for RTX alone and 9.3% for RTX+MTX). A poor disease control was observed in 14.2% and 13.5% of patients treated with RTX+MTX and RTX, respectively; while 12 patients (4.5% in RTX+MTX, and 2.5% in RTX group) suspended therapy for AE. CONCLUSIONS: RTX showed a good efficacy and safety profile in the real-life management of RA patients regardless of the association with MTX.