N Engl J Med 2022 01;386(4):316-326
From the Division of Rheumatology, Mayo Clinic, Rochester, MN (S.R.Y.); the Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (D.L.B.); the Division of Rheumatology, University of Nebraska Medical Center, Omaha (T.R.M.); the Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill (G.G.K.); Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas (R.F.); Pfizer, Madrid (J.L.R.); Pfizer, New York (R.G.); Pfizer, Groton, CT (S.M., C.W., K.S.K., C.A.C.); Pfizer, Shanghai, China (Y.S.); and Pfizer, Peapack, NJ (A.B.S.).
Background: Increases in lipid levels and cancers with tofacitinib prompted a trial of major adverse cardiovascular events (MACE) and cancers in patients with rheumatoid arthritis receiving tofacitinib as compared with a tumor necrosis factor (TNF) inhibitor.
Methods: We conducted a randomized, open-label, noninferiority, postauthorization, safety end-point trial involving patients with active rheumatoid arthritis despite methotrexate treatment who were 50 years of age or older and had at least one additional cardiovascular risk factor. Patients were randomly assigned in a 1:1:1 ratio to receive tofacitinib at a dose of 5 mg or 10 mg twice daily or a TNF inhibitor. Read More