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Tofacitinib for the treatment of ankylosing spondylitis: a phase iii, randomised, double-blind, placebo-controlled study

Annals of Rheumatic Diseases Apr 30, 2021

Deodhar A, Sliwinska-Stanczy P, Xu H, et al. - In this study, the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS) was investigated. Researchers designed phase III, randomized double-blind, placebo-controlled study including patients aged ≥ 18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs and an inadequate response or intolerance to ≥ 2 non-steroidal anti-inflammatory drugs. Individuals were assigned randomly in a 1:1 ratio to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. A total of 269 patients were included in this study: tofacitinib, n=133; placebo, n=136. Tofacitinib demonstrated significantly greater efficacy vs placebo in adults with active AS. There were no new potential safety risks.

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