HealthDay News — For patients with rheumatoid arthritis aged 50 years or older with 1 or more additional cardiovascular risk factors, increased risks for major adverse cardiovascular events (MACE) and cancer are seen with tofacitinib compared with a tumor necrosis factor (TNF) inhibitor, according to a study published in the January 27 issue of the New England Journal of Medicine.
Steven R. Ytterberg, MD, from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted an open-label, noninferiority, postauthorization, safety end-point trial involving patients with active rheumatoid arthritis despite methotrexate treatment who were aged 50 years or older and had one or more additional cardiovascular risk factors. Patients were randomly assigned to receive tofacitinib, 5- or 10mg twice daily, or a TNF inhibitor in a 1:1:1 ratio (1455, 1456, and 1451 patients, respectively).
The researchers found that the incidences of MACE and cancer were higher with the combined tofacitinib doses (3.4 and 4.2%, respectively) than with a TNF inhibitor (2.5 and 2.9%, respectively) during a median follow-up of 4.0 years, with hazard ratios of 1.33 (95% CI, 0.91 to 1.94) for MACE and 1.48 (95% CI, 1.04 to 2.09) for cancer; the noninferiority of tofacitinib was not demonstrated. Compared with a TNF inhibitor, higher incidences of adjudicated opportunistic infections, all herpes zoster, and adjudicated nonmelanoma skin cancer were seen with tofacitinib. The three groups had similar efficacy, with improvements from month 2 through trial completion.
“The increase in risk with tofacitinib as compared with TNF inhibitors must be balanced against patient preferences for oral medication,” write the authors of an accompanying editorial.
The study was funded by Pfizer, the manufacturer of tofacitinib.