Abstract
BackgroundThere are limited data regarding efficacy of abatacept treatment for rheumatoid arthritis (RA) outside clinical trials. Quality registers have been useful for observational studies on tumor necrosis factor inhibition in clinical practice. The aim of this study was to investigate clinical efficacy and tolerability of abatacept in RA, using a national register.MethodsRA patients that started abatacept between 2006 and 2017 and were included in the Swedish Rheumatology Quality register (N = 2716) were investigated. Survival on drug was estimated using Kaplan-Meier analysis. The European League Against Rheumatism (EULAR) good response and Health Assessment Questionnaire (HAQ) response (improvement of ≥ 0.3) rates (LUNDEX corrected for drug survival) at 6 and at 12 months were assessed. Predictors of discontinuation were investigated by Cox regression analyses, and predictors of clinical response by logistic regression. Significance-based backward stepwise selection of variables was used for the final multivariate models.ResultsThere was a significant difference in drug survival by previous biologic disease-modifying antirheumatic drug (bDMARD) exposure (p < 0.001), with longer survival in bionaïve patients. Men (hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.74–0.98) and methotrexate users (HR 0.85, 95% CI 0.76–0.95) were less likely to discontinue abatacept, whereas a high pain score predicted discontinuation (HR 1.14 per standard deviation, 95% CI 1.07–1.20). The absence of previous bDMARD exposure, male sex, and a low HAQ score were independently associated with LUNDEX-corrected EULAR good response. The absence of previous bDMARD exposure also predicted LUNDEX-corrected HAQ response.ConclusionsIn this population-based study of RA, bDMARD naïve patients and male patients were more likely to remain on abatacept with a major clinical response.
Highlights
There are limited data regarding efficacy of abatacept treatment for rheumatoid arthritis (RA) outside clinical trials
Clinical effectiveness was assessed as proportions of patients remaining on abatacept over time and as the proportions of patients remaining on therapy and achieving predefined standard clinical outcomes—according to the LUNDEX method [15], which has been used in several register-based studies of Biologic disease-modifying antirheumatic drugs (bDMARDs) effectiveness [16, 17]
Variables reflecting disease activity and disease severity were comparable between the three categories of bDMARD exposure (Table 1)
Summary
There are limited data regarding efficacy of abatacept treatment for rheumatoid arthritis (RA) outside clinical trials. Quality registers have been useful for observational studies on tumor necrosis factor inhibition in clinical practice. The aim of this study was to investigate clinical efficacy and tolerability of abatacept in RA, using a national register. Rheumatoid arthritis (RA) is a chronic autoimmune disease that may lead to progressive joint damage and disability. Efficacy results observed in placebo-controlled randomized trial are sometimes different from the real-world effectiveness data. This can be due to patient selection, adherence to therapy, or other factors (i.e., Hawthorne effect) [5, 6]
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