The Food and Drug Administration (FDA) reports that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Xeljanz/Xeljanz XR (tofacitinib; Pfizer) compared with tumor necrosis factor (TNF) inhibitors.

Tofacitinib is currently FDA approved to treat certain adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ulcerative colitis. Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis.

When the FDA first approved tofacitinib, they required the manufacturer to conduct a safety clinical trial in patients with RA who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections. The trial studied 2 doses of tofacitinib in comparison with a TNF inhibitor. In February 2019 and July 2019, the FDA warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice daily dosage, and as a result, approved the addition of a boxed warning to the tofacitinib prescribing information. The clinical trial is now complete, and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared with patients treated with a TNF inhibitor. The FDA is awaiting additional results from the trial.

The FDA is recommending that health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue the medication for patients.

Food and Drug Administration (FDA). Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) [news release]. February 4, 2021. Available at: click here. Accessed February 4, 2021.