Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Tria
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ORIGINAL RESEARCH
Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial Atul Deodhar
. Philip Mease . Proton Rahman . Victoria Navarro-Compa´n
Helena Marzo-Ortega
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. Theresa Hunter . David Sandoval .
Andris Kronbergs . Luis Leon . Mingyang Shan . Ann Leung . Kurt De Vlam . Vibeke Strand Received: September 25, 2020 / Accepted: November 4, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: 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 in ixekizumab-treated patients in Assessment of Spondyloarthritis International Society (ASAS) response domains and other patient-reported outcomes (PROs) and (b) to Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40744020-00254-z) contains supplementary material, which is available to authorized users. A. Deodhar (&) Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA e-mail: [email protected] P. Mease Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA P. Rahman Memorial University of Newfoundland, St. John’s, NL, Canada V. Navarro-Compa´n Hospital Universitario La Paz, IdiPaz, Madrid, Spain H. Marzo-Ortega NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and LIRMM, University of Leeds, Leeds, WY, UK
determine how ASAS responses were associated with changes in patient global disease activity (PtGA), spinal pain, function, stiffness, fatigue, and spinal pain at night. Methods: COAST-X was a phase 3, 52-week multicenter, randomized, controlled trial investigating the efficacy and safety of 80-mg ixekizumab every 2 weeks (Q2W) and every 4 weeks (Q4W) in patients with active nr-axSpA. Changes from baseline in PROs were analyzed via mixed-effects models for repeated measures. Association analyses for ASAS responses used analysis of covariance with Scheffe´’s method.
T. Hunter D. Sandoval A. Kronbergs L. Leon M. Shan Eli Lilly and Company, Indianapolis, IN, USA A. Leung Syneos Health, Morrisville, NC, USA K. De Vlam Department of Rheumatology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium V. Strand Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA
Rheumatol Ther
Results: Patients treated with ixekizumab Q2W and Q4W reported significantly greater improvements in PtGA, spinal pain, function, and stiffness at week 1, when these measures were first assessed, compared with placebo (p \ 0.05). ASAS40 responders, in comparison to ASAS20 non-responders, had the highest correlations with improvements in all response domains (PtGA, spinal pain, function, and stiffness) as well as fatigue and spinal pain at night (p \ 0.001). ASAS40 responses were associated with 3.5- to 48.0-fold greater improvements in these PROs, with the highest values for PtGA and function, compared
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