Key clinical point: Tofacitinib was associated with a higher risk for major adverse cardiovascular events (MACE) and cancer than tumor necrosis factor (TNF) inhibitors in a cardiovascular risk-enriched population of patients with active rheumatoid arthritis (RA).
Major finding: During a median follow-up of 4 years, the combined tofacitinib doses vs. TNF inhibitors were associated with a higher incidence of MACE (hazard ratio [HR] 1.33; 95% CI 0.91-1.94) and cancer (HR 1.48; 95% CI 1.04-2.09), not meeting the predefined criteria for noninferiority.
Study details: The findings come from the noninferiority, phase 3b-4, safety end-point ORAL Surveillance trial involving 4,362 patients aged 50 years or older with at least 1 additional cardiovascular risk factor who had active RA despite methotrexate treatment. The patients were randomly assigned to 5 mg or 10 mg tofacitinib twice daily or a TNF inhibitor.
Disclosures: This study was funded by Pfizer. Some of the authors declared being employees or holding stocks at Pfizer, whereas some others declared serving as a consultant or receiving grants from various sources.
Source: Ytterberg SR et al. N Engl J Med. 2022;386:316-326 (Jan 27). Doi: 10.1056/NEJMoa2109927