Safety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data Analysis of Nine Clinical Trials.

ABSTRACT:

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 (IRs) of adverse events (AEs) per 100 patient-years of exposure were calculated for abatacept- and placebo-treated patients. AEs 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

SUBMITTER: Simon TA 

PROVIDER: S-EPMC6858048 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature