Open AccessSafety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data Analysis of Nine Clinical Trials
Author(s) -
Simon Teresa A.,
Soule Benjamin P.,
Hochberg Marc,
Fleming Douglas,
Torbeyns Anne,
Banerjee Subhashis,
Boers Maarten
Publication year - 2019
Publication title -
acr open rheumatology
Language(s) - English
Resource type - Journals
ISSN - 2578-5745
DOI - 10.1002/acr2.1034
Subject(s) - abatacept , medicine , placebo , rheumatoid arthritis , adverse effect , incidence (geometry) , pathology , rituximab , physics , alternative medicine , lymphoma , optics
Objective To assess the safety of abatacept treatment in rheumatoid arthritis ( RA ) using integrated data from multiple clinical trials. Methods Data from nine double‐blind, placebo‐controlled studies of abatacept treatment (seven intravenous, two subcutaneous) in patients with RA were pooled, focusing on safety events in the double‐blind treatment period of each study. Incidence rates ( IR s) of adverse events ( AE s) per 100 patient‐years of exposure were calculated for abatacept‐ and placebo‐treated patients. AE s in abatacept‐treated patients were combined regardless of dose and formulation. Results In total, 2653 patients received abatacept and 1485 received placebo, with 2357 and 1254 patient‐years of exposure, respectively. The mean ( SD ) durations of exposure in the abatacept and placebo groups were 10.8 (3.3) and 10.3 (3.5) months, respectively. The IR s (95% confidence interval [ CI ]) for serious AE s were 14.8 (13.3, 16.5) and 14.6 (12.5, 17.0) in the abatacept and placebo groups, respectively. Death occurred in 12 (0.5%) and 12 (0.8%) patients in the abatacept and placebo groups, respectively, and was most commonly caused by cardiac disorders. Malignancies were observed in 31 patients (1.2%) treated with abatacept ( IR : 1.32 [95% CI : 0.90, 1.87]) versus 14 (0.9%; IR : 1.12 [0.61, 1.88]) who received placebo. Solid organ tumor was the most frequent malignancy reported in both groups (abatacept: 1.0%; IR : 1.11 [95% CI : 0.72, 1.62]; placebo: 0.8%; 0.96 [0.50, 1.67]). Conclusion In this integrated analysis, the IR s of safety events in the abatacept and placebo groups were similar with no new safety concerns identified.