Does Anti-Tumor Necrosis Factor-α Therapy Affect Risk of Serious Infection and Cancer in Patients with Rheumatoid Arthritis?: A Review of Longterm Data

Given the important role tumor necrosis factor-alpha (TNF-alpha) antagonists play in managing rheumatoid arthritis and the concern for safety during longterm therapy, we reviewed the latest evidence regarding longterm risk of infection and malignancy with TNF-alpha antagonists. Our objective was to provide clinicians with information that can be used to counsel and monitor patients who may be candidates for biologic therapy for rheumatoid arthritis (RA). Risk is examined in the context of background infection and malignancy rates in RA. Randomized controlled trial (RCT) data and observational studies summarizing the risk of infection and/or malignancy in RA and specific risks associated with the use of anti-TNF-alpha biologic agents (adalimumab, infliximab, and etanercept) were identified through a PubMed search. Overall, patients with RA appear to have an approximately 2-fold increased risk of serious infection compared to the general population and non-RA controls, irrespective of TNF-alpha antagonist use. Although data on infection rates with TNF-alpha antagonist use are contradictory, caution is merited. Recent analyses suggest that the risk of infection is highest within the first year. Regarding malignancy risk, RCT and observational data are also conflicting; however, caution is warranted regarding lymphoproliferative cancers in children and adolescents. (First Release May 152011; J Rheumatol 2011;38:1552-62; doi:10.3899/jrheum.100995)