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November 8, 2006

Risk of Serious Infections and Malignancies With Anti-TNF Antibody Therapy in Rheumatoid Arthritis—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;296(18):2201-2204. doi:10.1001/jama.296.18.2203-b

In Reply: Dr Costenbader and colleagues add recently published evidence to our analysis of rare events in patients with RA treated with anti-TNF agents. Two eligible trials1,2 have been published in full since the end date of our literature search (December 2005), of which only the PREMIER trial results were included in their update. While we have not had the opportunity to fully examine the PREMIER data set with respect to time of occurrence of malignancies, we updated our meta-analysis including new data from both trials (Table). The results are consistent with the findings in our article. Applying Mantel-Haenszel methods incorporating these additional data, the pooled OR for malignancy in patients with RA using anti-TNF antibodies vs placebo remains significantly elevated at 2.4 (95% CI, 1.2-4.8); the OR for serious infections also remains significant at 1.8 (95% CI, 1.2-2.6). These ORs are based on the assessment of the 10 high-quality randomized controlled trials, which included 5788 patients.