Authors
Désirée van der Heijde, In-Ho Song, Aileen L Pangan, Atul Deodhar, Filip Van den Bosch, Walter P Maksymowych, Tae-Hwan Kim, Mitsumasa Kishimoto, Andrea Everding, Yunxia Sui, Xin Wang, Alvina D Chu, Joachim Sieper
Publication date
2019/12/7
Journal
The Lancet
Volume
394
Issue
10214
Pages
2108-2117
Publisher
Elsevier
Description
Background
The JAK pathway is a potential therapeutic target in ankylosing spondylitis. This study assessed the efficacy and safety of upadacitinib, a selective JAK1 inhibitor, in patients with ankylosing spondylitis.
Methods
This multicentre, randomised, double-blind, placebo-controlled, two-period, parallel-group, phase 2/3 study, SELECT-AXIS 1, enrolled adults in 62 sites in 20 countries. Eligible patients had active ankylosing spondylitis, fulfilled modified New York criteria, were previously untreated with biological disease-modifying antirheumatic drugs, and had inadequate response to at least two or intolerance or contraindication to non-steroidal anti-inflammatory drugs. Patients were randomly assigned 1:1 using interactive response technology to take oral upadacitinib 15 mg once daily or oral placebo for the 14-week period 1; only period 1 data are reported here. The primary endpoint was the composite …
Total citations
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