Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial

Publication date: Available online 5 December 2019Source: The LancetAuthor(s): Atul Deodhar, Désirée van der Heijde, Lianne S Gensler, Tae-Hwan Kim, Walter P Maksymowych, Mikkel Østergaard, Denis Poddubnyy, Helena Marzo-Ortega, Louis Bessette, Tetsuya Tomita, Ann Leung, Maja Hojnik, Gaia Gallo, Xiaoqi Li, David Adams, Hilde Carlier, Joachim Sieper, Frederic Morin, Proton Rahman, Federico ArielSummaryBackgroundIxekizumab, a high-affinity interleukin-17A (IL-17A) monoclonal antibody, has previously shown efficacy in radiographic axial spondyloarthritis (also known as ankylosing spondylitis). We aimed to evaluate the efficacy and safety of ixekizumab, an IL-17 inhibitor, in non-radiographic axial spondyloarthritis. Here, we report the primary results of COAST-X.MethodsCOAST-X was a 52-week, randomised, double-blind, placebo-controlled, parallel-group study done at 107 sites in 15 countries in Europe, Asia, North America, and South America. Eligible participants were adults (aged ≥18 years) with active axial spondyloarthritis without definite radiographic sacroiliitis (non-radiographic axial spondyloarthritis), objective signs of inflammation (via MRI or C-reactive protein), and an inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomly assigned (1:1:1) to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo. Changing background medications or switching to open-label ixekizumab Q2W, ...
Source: The Lancet - Category: General Medicine Source Type: research