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Tumor necrosis factor-α (TNF) inhibitors raise risk for infection in patients with rheumatoid arthritis. To quantitate this risk, Japanese investigators compared outcomes in 646 patients who were treated with TNF inhibitors (etanercept [Enbrel] or infliximab [Remicade]) and 498 patients who were treated with nonbiologic disease-modifying antirheumatic drugs. Median follow-up was about 1 year in both groups.
Thirty-eight serious infections occurred in the TNF-inhibitor group (25 bacterial, 11 opportunistic, and 2 other), and 12 occurred in the unexposed group (6.4 vs. 2.6 infections per 100 person-years). In a multivariate analysis that was controlled for baseline differences between the two groups, TNF-inhibitor exposure doubled risk for ser…