ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0890

Ixekizumab Treatment Improves Fatigue, Spinal Pain, Stiffness, and Sleep in Patients with Nonradiographic Axial Spondyloarthritis

Philip Mease1, Atul Deodhar2, Proton Rahman3, Helena Marzo-Ortega4, Vibeke Strand5, Theresa Hunter6, David Adams7, David Sandoval6, Andris Kronbergs6, Baojin Zhu7, Ann Leung8, Soyi Liu-Leage7 and Victoria Navarro-Compán9, 1Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 2Oregon Health & Science University, Portland, OR, 3Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 4The University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK, Leeds, United Kingdom, 5Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 6Eli Lilly and Company, Indianapolis, 7Eli Lilly and Company, Indianapolis, IN, 8Syneos Health, Morrisville, 9Hospital Universitario La Paz IdiPaz, Madrid, Pais Vasco, Spain

Meeting: ACR Convergence 2020

Keywords:

Session Information

Date: Saturday, November 7, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II

Session Type: Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Common symptoms of axial spondyloarthritis (axSpA) include fatigue, spinal pain, stiffness, and sleep problems, which can impair health-related quality of life. Ixekizumab (IXE) treatment shows efficacy in active non-radiographic axSpA (nr-axSpA).1 The objective of this study was to assess fatigue, spinal pain, stiffness, and sleep with IXE treatment versus placebo in patients (pts) with active nr-axSpA up to 16 and 52 weeks.

Methods: In COAST-X, pts with active nr-axSpA were randomized to 52 weeks of double-blind IXE 80 mg once every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo. Data were collected from baseline to Week 52.

Results: At Week 16, IXE Q4W significantly improved fatigue, spinal pain, and stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs placebo (Table). At Week 52, IXE Q4W significantly improved stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs placebo. Numeric improvements in sleep were not significant vs placebo. Week 1, and up to Week 16, IXE Q4W and Q2W significantly reduced spinal pain and stiffness vs PBO; stiffness was significantly reduced vs placebo up to Week 52 (Figure).

Conclusion: IXE Q4W and/or Q2W significantly improved spinal pain, spinal pain at night, and stiffness vs placebo at 16 and 52 weeks in pts with nr-axSpA. IXE Q4W also improved fatigue at 16 weeks in these pts. Numerical improvements in sleep were not significant vs placebo.

Reference:
      1. Deodhar A, et al. Lancet. 2020;395(10217):53-64.

*P < .05 vs PBO; †P≤.001 vs PBO. ITT population: all randomized pts. Pts needing rescue treatment after Week 16 per investigator could switch to open-label IXE Q2W; observations at visits thereafter not included in analyses. Baseline values similar across treatments. Numerical improvements in BASDAI-fatigue not significant vs PBO. ᵃScored 0 (no pain) to 10 (most severe pain) on NRS ᵇMean score BASDAI questions 5 (intensity) and 6 (duration) ᶜScored 1–10 on NRS ᵈScored 0 (no fatigue) to 10 (as bad as you can imagine) ᵉJenkins Sleep Evaluation Questionnaire scored 0 to 20: each of 4 items scored 0 (0 days) to 5 (22–30 days) ᶠScored 0 (not active) to 10 (very active) on NRS BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BL=baseline; ITT=intent-to-treat IXE=Ixekizumab; N=number of pts in ITT population; NRS=numeric rating scale; PBO=placebo; pt=patient; Q2W=every 2 weeks; Q4W=every 4 weeks; vs=versus; wk=week.

*P < .05 vs PBO; †P≤.001 vs PBO. Significant differences between placebo and IXE Q4W and IXE Q2W are shown by orange and blue symbols, respectively. Changes from BL (Least squares mean) up to Wk 52 were analysed using MMRM analysis in the ITT population, which included all randomized pts. BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BL=baseline; ITT=intent-to-treat IXE=Ixekizumab; MMRM=mixed-effects model of repeated measures; PBO=placebo; pt=patient; Q2W=every 2 weeks; Q4W=every 4 weeks; vs=versus; wk=week

Disclosure: P. Mease, Amgen, 2, 5, 8, Bristol-Myers Squibb, 2, 5, Novartis, 2, 5, 8, Pfizer Inc, 2, 5, 8, Sun, 2, 5, UCB, 2, 5, 8, AbbVie, 2, 5, 8, Gilead, 2, 5, Janssen, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, GlaxoSmithKline, 5; A. Deodhar, AbbVie, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, Janssen, 5, Pfizer, 2, 5, Boehringer Ingelheim, 5, UCB Pharma, 2, 5, Amgen Inc., 5, Celgene, 5, Galapagos, 5, Bristol-Myers Squibb, 2; P. Rahman, AbbVie, 5, 8, Amgen, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Janssen, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Abbott, 8, Centacor, 8, Merck, 8, Bristol Myers Squibb, 5, 8, Roche, 5; H. Marzo-Ortega, Novartis, 2, 5, 8, Janssen, 2, 5, 8, Eli Lilly, 5, 8, Pfizer, 5, 8, UCB, 5, 8, AbbVie Inc., 5, 8, Celgene, 5, 8, Takeda Pharmaceutical Company, 5, 8; V. Strand, AbbVie, 5, Amgen, 5, Celltrion, 5, Janssen, 5, Merck, 5, Novartis, 5, Regeneron, 5, Sanofi, 5, UCB, 5, Genentech/Roche, 5, GSK, 5, Pfizer, 5, Bayer, 5, Bristol-Myers Squibb, 5, Boehringer Ingelheim, 5, Galapagos, 5, Lilly, 5, Gilead, 5, Samsung, 5, Servier, 5, Setpoint, 5, Arena, 5, AstraZeneca, 5, Horizon, 5, Ichnos, 5, Inmedix, 5, Sandoz, 5; T. Hunter, Eli Lilly and Company, 1, 3; D. Adams, Eli Lilly and Company, 1, 3; D. Sandoval, Eli Lilly and Company, 3; A. Kronbergs, Eli Lilly and Company, 1, 3; B. Zhu, Eli Lilly and Company, 1, 3; A. Leung, Syneos Health, 3; S. Liu-Leage, Eli Lilly and Company, 3, 4; V. Navarro-Compán, Novartis Pharma, 1, 5, 8, AbbVie Inc., 5, 8, Eli Lilly and Company, 5, 8, Pfizer Inc., 5, UCB, 5, 8.

To cite this abstract in AMA style:

Mease P, Deodhar A, Rahman P, Marzo-Ortega H, Strand V, Hunter T, Adams D, Sandoval D, Kronbergs A, Zhu B, Leung A, Liu-Leage S, Navarro-Compán V. Ixekizumab Treatment Improves Fatigue, Spinal Pain, Stiffness, and Sleep in Patients with Nonradiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/ixekizumab-treatment-improves-fatigue-spinal-pain-stiffness-and-sleep-in-patients-with-nonradiographic-axial-spondyloarthritis/. Accessed .

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