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Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): A multicentre, randomized, double-blind, placebo-controlled, phase 2/3 trial

The Lancet Dec 15, 2019

van der Heijde D, Song IH, Pangan AL, et al. - In this multicentre, randomized, double-blind, placebo-controlled, two-period, parallel-group, phase 2/3 study (SELECT-AXIS 1), experts recruited adults from 62 sites in 20 countries who had active ankylosing spondylitis and who were formerly untreated with biological DMARDs, and had incomplete response to at least two or intolerance or contraindication to NSAIDs in order to evaluate the efficiency and safety of upadacitinib, a selective JAK1 inhibitor, in individuals with ankylosing spondylitis. Between Nov 30, 2017, and Oct 15, 2018, 187 individuals were randomized to upadacitinib 15 mg (n = 93) or to placebo (n = 94). In people with active ankylosing spondylitis who had an insufficient response or contraindication to non-steroidal anti-inflammatory drugs, upadacitinib 15 mg was effective and well-tolerated.
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