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The standard of care for patients with rheumatoid arthritis (RA) has been to add a tumor necrosis factor (TNF) inhibitor to methotrexate, but many patients still do not achieve remission or low disease activity. Tofacitinib, an orally administered Janus kinase inhibitor that was FDA-approved in November 2012 for RA (5 mg twice daily), is superior to placebo and methotrexate and equivalent to adalimumab.
In this placebo-controlled, manufacturer-sponsored study, investigators examined twice-daily tofacitinib (5 mg or 10 mg) added to ongoing methotrexate therapy in RA patients with moderate-to-severe disease who had inadequate responses to at least one anti-TNF agent. (At month 3, placebo recipients were re-randomized to one of the two tofaciti…