XELJANZ® (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors.

Summary 

• In the completed clinical trial (A3921133) in patients with rheumatoid arthritis (RA) who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of myocardial infarction was observed with tofacitinib compared to TNF-alpha inhibitors. 
• The study also showed an increased incidence of malignancies excluding NMSC, particularly lung cancer and lymphoma, with tofacitinib compared to TNF-alpha inhibitors. 
• Tofacitinib should only be used in patients over 65 years of age, in patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors if no suitable treatment alternatives are available. 
• Prescribers should discuss with the patients the risks associated with the use of Xeljanz, including myocardial infarction, lung cancer and lymphoma.