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Serious Infections with Anti-TNF Drugs for RA

The overall rate of serious infections was the same with anti-TNF drugs as with traditional DMARDs, but skin and soft-tissue infections were more common.

Patients who receive anti–tumor necrosis factor (TNF) drugs for rheumatoid arthritis (RA) are at risk for serious infections. U.K. researchers used a national registry of RA patients to compare rates of serious infections in 7664 patients receiving anti-TNF drugs (etanercept [Enbrel], infliximab [Remicade], and adalimumab [Humira]) and 1354 patients receiving only disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. Serious infections were those that resulted in hospitalization or death or that required intravenous antibiotics.

The rate of serious infections was higher in the anti-TNF group than in the DMARD group (53 vs. 41 events per 1000 person-years), with similar rates for each of the three anti-TNF drugs. After adjustment for potentially confounding variables, overall rates in the anti-TNF and DMARD groups were not significantly different (incidence rate ratio [IRR], 1.03). However, skin and soft-tissue infections were significantly more common in the anti-TNF group than in the DMARD group (IRR, 4.28). Nineteen serious intracellular bacterial infections occurred, all in anti-TNF drug recipients: tuberculosis (10 cases, 7 of which were extrapulmonary), listeria (3), salmonella (3), legionella (2), and Mycobacterium fortuitum (1).

Comment: This study presumably captured most U.K. patients who received anti-TNF drugs during a defined interval, and the results thus should be representative of the infectious complications seen with these drugs. Key findings are the increased incidence of skin and soft-tissue infections and the infections with intracellular organisms (including extrapulmonary tuberculosis). Because the study did not include untreated controls, it's unclear how these infection rates compare with rates in the general population.

— Allan S. Brett, MD

Published in Journal Watch General Medicine September 7, 2006

Citation(s):

Dixon WG et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti–tumor necrosis factor therapy. Arthritis Rheum 2006 Aug; 54:2368-76.

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