Efficacy of upadacitinib in a randomized trial of patients with active ulcerative colitis
Gastroenterology Mar 03, 2020
Sandborn WJ, Ghosh S, Panes J, et al. - Researchers conducted a multicenter, double-blind, phase 2b study to test the safety and effectiveness of upadacitinib [an oral selective inhibitor of Janus kinase 1] as induction therapy for ulcerative colitis (UC). The sample consisted of 250 adults with moderately to severely active UC and inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressive agents, and/or biologic therapies. Study participants were randomly assigned to groups that received placebo or induction therapy with upadacitinib (7.5 mg, 15 mg, 30 mg, or 45 mg, extended release), once daily for 8 weeks. At week 8, 8.5%, 14.3%, 13.5%, and 19.6% of patients receiving 7.5 mg, 15 mg, 30 mg, or 45 mg upadacitinib, respectively, achieved clinical remission compared with none of those receiving placebo. The authors concluded that, in patients with moderately to severely active UC, 8 weeks treatment with upadacitinib was more effective than a placebo for inducing remission.
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