Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial

• DOI: 10.1007/s40744-020-00254-z
• Publication Date: 2020-12-07T17:18:16Z
• Authors: Atul Deodhar; Philip Mease; Proton Rahman; Victoria Navarro-...; Helena Marzo-Ortega; Theresa Hunter; David Sandoval; Andris Kronbergs; Luis Leon; Mingyang Shan; Ann Leung; Kurt De Vlam; Vibeke Strand
• Keywords: Ixekizumab; Axial spondyloarthritis; Back Pain; Repeated measures design

Ixekizumab, an interleukin-17A antibody, has shown efficacy in non-radiographic axial spondyloarthritis (nr-axSpA). The objectives of this analysis were (a) to measure improvement ixekizumab-treated patients Assessment Spondyloarthritis International Society (ASAS) response domains and other patient-reported outcomes (PROs) (b) determine how ASAS responses associated with changes patient global disease activity (PtGA), spinal pain, function, stiffness, fatigue, pain at night. COAST-X was a phase 3, 52-week multicenter, randomized, controlled trial investigating the safety 80-mg ixekizumab every 2 weeks (Q2W) 4 (Q4W) active nr-axSpA. Changes from baseline PROs analyzed via mixed-effects models for repeated measures. Association analyses used covariance Scheffé's method. Patients treated Q2W Q4W reported significantly greater improvements PtGA, stiffness week 1, when these measures first assessed, compared placebo (p < 0.05). ASAS40 responders, comparison ASAS20 non-responders, had highest correlations all (PtGA, stiffness) as well fatigue night 0.001). 3.5- 48.0-fold PROs, values PtGA non-achievement. As early nr-axSpA significant those taking placebo. responders than non-responders. Improvements function appear be major drivers achieving NCT02757352.