ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1510

Ixekizumab Improves Fatigue, Pain, and Sleep up to 52 Weeks in Patients with Radiographic Axial Spondyloarthritis

Atul Deodhar1, Philip Mease 2, Proton Rahman 3, Victoria Navarro-Compán 4, Vibeke Strand 5, Theresa Hunter 6, David Sandoval 7, Jeffrey Lisse 7, Fangyi Zhao 7 and Helena Marzo-Ortega 8, 1Oregon Health & Science University, Portland, OR, 2Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, 3Memorial University, Newfoundland, NL, Canada, 4University Hospital La Paz, IdiPaz, Madrid, Spain, 5Division of Immunology/Rheumatology, Stanford University, Stanford, CA, 6Eli Lilly and Company, Indianapolis, 7Eli Lilly and Company, Indianapolis, IN, 8NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, University of Leeds, Leeds, Leeds, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: ,

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

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

Background/Purpose: Axial spondyloarthritis (axSpA) is an inflammatory condition affecting sacroiliac joints and axial skeleton, characterized by fatigue, spinal pain, and sleep disturbances that negatively affect patient health-related quality of life.1 Ixekizumab (IXE) has demonstrated efficacy in treatment of radiographic axial spondyloarthritis (r-axSpA) in both biologic disease-modifying antirheumatic drug (bDMARD) naïve and tumor necrosis factor inhibitor (TNFi) experienced patients.2,3 The purpose of this analysis was to evaluate the impact of IXE on fatigue, spinal pain and sleep pattern in patients with r-axSpA over 52 weeks.

Methods: COAST-V and COAST-W were Phase 3 randomized controlled trials (RCTs) conducted to evaluate the efficacy and safety of IXE in bDMARD-naïve and TNFi-experienced patients with r-axSpA, respectively. In both RCTs, patients were randomized to receive IXE 80mg once every two weeks (IXEQ2W), IXE 80 mg once every 4 weeks (IXEQ4W), active reference arm (adalimumab 40 mg [ADAQ2W]) in COAST-V or placebo (PBO) up to Week 16. Patients initially randomized to IXE continued on the same regimen up to Week 52. Patients on PBO were re-randomized to either IXEQ2W or IXEQ4W at Week 16. After a washout period of 6 weeks, patients on ADA were switched to either IXEQ2W or IXEQ4W regimens and received their first IXE dose at Week 20. Fatigue Numeric Rating Scale (NRS) and Jenkins Sleep Evaluation Questionnaire (JSEQ) data were collected at baseline, Weeks 8, 16, 36 and 52. Patient global assessments of disease activity, spinal pain and spinal pain at night were collected at baseline and each post-baseline visit to Week 52. Mean changes from baseline up to Week 16 were analyzed using mixed effects model of repeated measures (MMRM). After Week 16, changes from baseline during extended treatment period were summarized as raw means after imputing the missing data using modified Baseline Observation Carried Forward (mBOCF).

Results: At Week 52, IXEQ2W and IXEQ4W treatments continued to improve fatigue, patient global assessment of disease activity, spinal pain and sleep in bDMARD-naive and TNFi-experienced patients (Table 1). Significant reductions in fatigue and spinal pain at night were reported as early as Week 8 and Week 1 respectively, in patients treated with IXE compared with PBO. Improvements in these parameters at Week 16 with both IXE arms were maintained up to Week 52 (Figure 1).

Conclusion: Fatigue, spinal pain, and sleep improved with IXE treatment over 52 weeks in both biologic-naïve and TNFi-experienced patients with r-axSpA.

References

  1. Strand V, et al. J Clin Rheumatol. 2017;23(7):383–391.
  2. van der Heijde D, et al. Lancet. 2018;392(10163):2441-2451.
  3. Deodhar A, et al. Arthritis Rheumatol. 2019;71(4):599-611.


Table

Change from baseline in fatigue, patient global assessment of disease activity, spinal pain and sleep in biologic-naive -COAST-V- and TNFi-experienced -COAST-W- patients with r-axSpA -extended treatment population-


90397 layout pdf

Change from baseline in fatigue, spinal pain at night over 52 weeks in A- Biologic-naïve patients -Coast-V- and B- TNFi-experienced patients -COAST-W-

Disclosure: A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9; P. Mease, Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Genentech, Janssen, Novartis, Pfizer, Roche, UCB, 2, 5, Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB, 8, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Abbvie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB., 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB, 2, Abbvie, Amgen, Brsitol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Brsitol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Brsitol Myers Squibb,Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, Amgen, 2, 5, 6, 8, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GSK, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, and UCB, 5, BMS, 2, 5, 8, Boehringer Ingelheim, 2, 5, Boerhinger Ingelheim, 5, Bristol Myers Squibb, 2, 5, 8, Bristol Myers Squibb Co., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 6, 8, Celgene, 2, 5, 6, 8, Celgene Corp., 2, 5, 8, CORRONA, 5, Eli Lilly, 2, 5, 8, Galapagos, 2, 5, 8, Genentech, 2, 5, 6, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, 8, Leo, 2, 5, 8, Lilly, 2, 5, 6, 8, Merck, 2, 5, 8, Novartis, 2, 5, 6, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 6, Sun, 2, 5, SUN, 2, 5, Sun Pharma, 2, 5, Sun Pharmaceutical Industries, 2, 5, Sun Pharmaceutical Industries, Inc., 2, 5, 8, UCB, 2, 5, 6, 8, UCB Pharma, 2, 5, 8; P. Rahman, AbbVie, 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, and Novartis, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, and UCB, 5, AbbVie, Eli Lilly, Pfizer, Novartis , UCB, 5, 8, Eli Lilly and Company, 5, 8, Janssen, 2, 5, 8, Janssen Inc., 2, 5, 8, Janssen, Novartis, 2, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8; V. Navarro-Compán, AbbVie, 5, 8, Bristol, 8, Bristol, Roche, 8, Eli Lilly and Company, 5, 8, Eli Lilly, Novartis, Abbvie, UCB, MSD, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, Roche, 8, UCB, 5, 8; V. Strand, Abbvie, 5, AbbVie, 5, Amgen, 5, Amgen, Abbvie, Bayer, BMS, Boehringer Ingelheim, Celltrion, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, 5, AstraZeneca, 5, AURA, 8, Bayer, 5, BMS, 5, Boehringer Ingelheim, 5, Celgene, 5, Celltrion, 5, Cleveland Clinic, 8, CORRONA, 5, Crescendo, 5, Crescendo Bioscience, 5, Eli Lilly, 5, EMD Serono, 5, Genentech, 5, GlaxoSmithKline, 5, GSK, 5, Horizon, 5, Inmedix, 5, Janssen, 5, Kezar, 5, Lilly, 5, Merck, 5, NACCME, 8, Novartis, 5, Pfizer, 5, Purdue, 8, RA Forum, 8, RAN, 8, Regeneron, 5, Roche, 5, Samsung, 5, Sandoz, 5, Sanofi, 5, Servier, 5, Setpoint, 5, SLRA, 8, UCB, 5, Up to Date, 7, Washington University, 8, WIR, 8, WRA, 8; T. Hunter, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; D. Sandoval, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; J. Lisse, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; F. Zhao, Eli Lilly, 1, 3, 4, Eli Lilly and Company, 1, 3, 4; H. Marzo-Ortega, AbbVie, 5, 8, AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, 5, Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer, Ucb, 5, 8, AbbVie, Celgene, Janssen, Lilly, Novartis,Pfizer and UCB, 8, Celgene, 5, 8, Eli Lilly and Company, 5, 8, Janssen, 2, 5, 8, Janssen and Novartis, 2, Janssen, Novartis, 2, Novartis, 2, 5, 8, Pfizer, 5, 8, UCB, 5, 8.

To cite this abstract in AMA style:

Deodhar A, Mease P, Rahman P, Navarro-Compán V, Strand V, Hunter T, Sandoval D, Lisse J, Zhao F, Marzo-Ortega H. Ixekizumab Improves Fatigue, Pain, and Sleep up to 52 Weeks in Patients with Radiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/ixekizumab-improves-fatigue-pain-and-sleep-up-to-52-weeks-in-patients-with-radiographic-axial-spondyloarthritis/. Accessed .

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