Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data.

ABSTRACT:

Background

To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials.

Methods

This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥ 1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated.

Results

In cumulative periods, 7044 patients received abatacept,

SUBMITTER: Simon TA 

PROVIDER: S-EPMC7798209 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature