Abstract
Tumor necrosis factor-α antagonists (anti-TNF agents) have been associated with increased risks of malignancies and serious infections in rheumatoid arthritis. However, available data on these risks remain sparse, and at times conflicting. Thus, at present, there are no precise and robust estimates of the risks of serious infections and malignancies with anti-TNF agents in rheumatoid arthritis. Discrepancies in data may be owing, in part, to methodological issues related to observational studies, including differences in study populations, comparison groups, definitions of outcomes and duration of follow-up, as well as possible channeling bias and precision error. Obtaining better estimates of uncommon risks with anti-TNF agents in rheumatoid arthritis will be challenging. Observational studies using large administrative databases, patient registries and postmarketing surveillance systems have the potential to add important information on the safety of these new therapies.
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