Risks and Benefits of Janus Kinase Inhibitors in Rheumatoid Arthritis — Past, Present, and Future

The Food and Drug Administration (FDA) mandated a safety study to be performed because of possible safety signals detected for the Janus kinase (JAK) inhibitor tofacitinib. As Ytterberg et al. report in this issue of the Journal, the Oral Rheumatoid Arthritis Trial (ORAL) Surveillance was a 4-year randomized, open-label, noninferiority, postauthorization, safety end-point trial, in which 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 were randomly assigned in a 1:1:1 ratio to receive oral tofacitinib at a dose of 5 or 10 mg . . .