Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis

Abstract

Objective: To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA). Methods: Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations. Results: Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved significantly over 6 months. Separate multivariate analysis identified predictors of severe ADR, and severe infections and factors predictive of clinically meaningful DAS28 improvement after 6 months of treatment with abatacept. Conclusions: Abatacept was efficacious and well tolerated in a clinical setting. No new safety concerns were detected.

Association between chest computed tomography findings and respiratory adverse events in rheumatoid arthritis patients undergoing long‐term biological therapy

“…Several studies have reported an association between bDMARD therapy and ILD events, although the mechanism underlying the relationship is unclear . PMS conducted by pharmaceutical companies in Japan reported a high incidence of ILD events in RA patients receiving etanercept (0.6% of 7091 patients), infliximab (0.5% of 5000 patients), adalimumab (0.6% of 3000 patients), tocilizumab (0.4% of 7901 patients), and abatacept (0.3% of 3985 patients) . Consistent with these previous studies, no significant difference in ILD events was seen among bDMARDs used in the present study (TNFi vs non‐TNFi).…”

Long-term safety and effectiveness of adalimumab for the treatment of Japanese patients with rheumatoid arthritis: 3-year results from a postmarketing surveillance of 552 patients

“…Seven bDMARDs are currently approved in Japan for the treatment of RA and these drugs have different characteristics [1]. The results of postmarketing surveillance (PMS) that examined the safety and effectiveness of infliximab [2], etanercept [3][4][5], adalimumab (ADA) [6], tocilizumab (TCZ) [7,8] and abatacept [9] have been reported.…”

Circulating Th17.1 cells as candidate for prediction of therapeutic response to abatacept in patients with rheumatoid arthritis: exploratory research

“…Previous studies have found only few factors that adequately predict the therapeutic response to ABA in RA treatment. These include CRP [29], presence or absence of MTX combination, history of use of other biologics [30], positivity for ACPA and RF [31], and age [32]. In this study, no significant correlation was observed between these known baseline patient characteristics and the proportion of peripheral blood Th17.1 cells.…”