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Abstract Number: 1367

Impact of Ixekizumab on Work Productivity in Non-Radiographic Axial Spondyloarthritis Patients: Results from the COAST-X Trial at 52 Weeks

Atul Deodhar1, Philip Mease2, Lianne Gensler3, Proton Rahman4, Victoria Navarro-Compán5, Helena Marzo-Ortega6, Theresa Hunter7, David Sandoval7, Andris Kronbergs7, Baojin Zhu8, Ann Leung9 and Vibeke Strand10, 1Oregon Health & Science University, Portland, OR, 2Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, 3University of California San Francisco, San Francisco, CA, 4Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 5Hospital Universitario La Paz IdiPaz, Madrid, Pais Vasco, Spain, 6The University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK, Leeds, United Kingdom, 7Eli Lilly and Company, Indianapolis, 8Eli Lilly and Company, Indianapolis, IN, 9Syneos Health, Morrisville, 10Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA

Meeting: ACR Convergence 2020

Keywords: spondyloarthritis

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Session Information

Date: Sunday, November 8, 2020

Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster III

Session Type: Poster Session C

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

Background/Purpose: Patients with non-radiographic axial spondyloarthritis (nr-axSpA) experience impairments in health-related quality of life comparable to those seen in ankylosing spondylitis, including impacts on work productivity. Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A and effectively treats axial spondyloarthritis.1-3 This analysis evaluated the effect of IXE treatment for 52 weeks on work productivity and activity impairment as measured by absenteeism, presenteeism, overall work impairment, and activity impairment in patients with active nr-axSpA.

Methods: COAST-X (NCT02757352) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group outpatient study investigating the efficacy and safety of 80 mg IXE every 2 weeks (Q2W) and every 4 weeks (Q4W) compared to placebo (PBO) in 303 patients naïve to biologic disease-modifying anti-rheumatic drugs with active nr-axSpA during a 52-week treatment period. From Weeks 16 through 44, if patients’ disease activity required escalation of treatment at investigator discretion, patients were switched to open-label IXE Q2W or subsequent tumor necrosis factor inhibitor treatment. Analysis was performed for the intent-to-treat population, which included data up to the time of biologic switching. Patients who switched to open-label IXE were considered non-responders. Changes from baseline in work productivity were measured for patients reporting full- or part-time work at Weeks 16 and 52 with the Work Productivity and Activity Impairment (WPAI) Questionnaire for Spondyloarthritis and analyzed with an analysis of covariance model including treatment, geographic region, screening magnetic resonance imaging and C-reactive protein level status, and baseline value as factors. Missing data was imputed using the modified baseline observation carried forward.

Results: A majority of patients (63.5–65.7%) reported part-time or full-time paid work at baseline, with baseline scores for presenteeism and overall work activity slightly higher for patients in the PBO arm (p< 0.05). Patients treated with IXE Q4W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.003) and 52 (p=0.004), presenteeism at Weeks 16 (p=0.007) and 52 (p=0.003), and overall work impairment at Weeks 16 (p=0.014) and 52 (p=0.005; Figure). Patients treated with IXE Q2W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.007) and 52 (p=0.006; Figure). Patients treated with either IXE regimen had numeric improvements in all WPAI measures compared to those receiving PBO at Weeks 16 and 52 (Figure).

Conclusion: Patients with nr-axSpA treated with either IXE regimen had significant improvements in activity impairment compared to PBO. Patients receiving IXE Q4W also had significant improvements in presenteeism and overall work impairment. 

References:
     
1. Sieper J, et al. Clin Exp Rheumatol. 2016;34(6):975-83.
      2. Van der Heijde D, et al. Lancet. 2018;392(10163):2441-51.
      3. Deodhar A, et al. Arthritis Rheumatol. 2019;71(4):599-611.


Disclosure: 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. 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; L. Gensler, AbbVie, 5, GlaxoSmithKline, 5, Eli Lilly, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB Pharma, 2, 5; 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; V. Navarro-Compán, Novartis Pharma, 1, 5, 8, AbbVie Inc., 5, 8, Eli Lilly and Company, 5, 8, Pfizer Inc., 5, UCB, 5, 8; 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; T. Hunter, 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; 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.

To cite this abstract in AMA style:

Deodhar A, Mease P, Gensler L, Rahman P, Navarro-Compán V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Zhu B, Leung A, Strand V. Impact of Ixekizumab on Work Productivity in Non-Radiographic Axial Spondyloarthritis Patients: Results from the COAST-X Trial at 52 Weeks [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/impact-of-ixekizumab-on-work-productivity-in-non-radiographic-axial-spondyloarthritis-patients-results-from-the-coast-x-trial-at-52-weeks/. Accessed .
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