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To the Editor: Dr Bongartz and colleagues¹ reported the results of a meta-analysis of randomized clinical trials of the TNF-blocking monoclonal antibodies infliximab and adalimumab, finding an increased risk of serious infections and malignancies associated with their use. However, previous meta-analyses of randomized clinical trials of infliximab and adalimumab were conducted at the request of the US Food and Drug Administration (FDA), leading to revised product labeling for infliximab in September 2005 and for adalimumab in October 2005.

The FDA-requested analyses differ in several important respects from that of Bongartz et al. First, the FDA requested that the analyses be adjusted for duration of exposure, since a greater dropout rate in the control arms than in the TNF-blocker arm (due to lack of efficacy) hinders subsequent ascertainment of events in the control arm. Second, the FDA requested meta-analyses for all 3 approved TNF-blockers, including etanercept, not just the TNF-blocking monoclonal . . . [Full Text of this Article]

Sarah K. Okada, MD; Jeffrey N. Siegel, MD
Jeffrey.Siegel@fda.hhs.gov
Division of Anesthesia, Analgesia, and Rheumatology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, Md

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