ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1549

Primary 1-Year Data of Ixekizumab in Biologic Disease-Modifying Anti-rheumatic Drug-Naïve Patients with Radiographic Axial Spondyloarthritis Including Data in Patients Rerandomized from Adalimumab to Ixekizumab

Cheng-Chung Wei1, Lianne Gensler 2, Jessica Walsh 3, Robert B.M. Landewé 4, Tetsuya Tomita 5, Fangyi Zhao 6, Gaia Gallo 6, Hilde Carlier 7 and Maxime Dougados 8, 1Chung Shan Medical University, Taichung City, Taiwan (Republic of China), 2University San Francisco California, San Francisco, CA, 3Division of Rheumatology, University of Utah, Salt Lake City, UT, 4Amsterdam University Medical Center, Amsterdam, Netherlands, 5Osaka University Graduate School of Medicine, Osaka, Japan, 6Eli Lilly and Company, Indianapolis, IN, 7Eli Lilly and Company, Indianapolis, 8Hôpital Cochin, Paris, France

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: During 16 weeks of blinded treatment, ixekizumab (IXE) and an adalimumab (ADA) active reference arm were found superior to placebo (PBO) in improving signs and symptoms of radiographic axial spondyloarthritis (r-axSpA).1 Here, we assess the safety and efficacy of continuous treatment with IXE through 52 weeks in patients with r-axSpA and describe clinical response at Week 52 for patients who switched to IXE following 16 weeks of treatment with either ADA or PBO.

Methods: Participants were biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve adult patients with active r-axSpA per Assessment of Spondyloarthritis (SpA) international Society (ASAS) criteria (sacroiliitis centrally defined by modified New York criteria and ≥1 SpA feature) and inadequate response or intolerance to non-steroidal anti-inflammatory drugs. Patients were randomized 1:1:1:1 to receive 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W), 40 mg adalimumab (ADA) Q2W (active reference arm), or PBO. At Week 16, patients assigned to IXE continued their assigned treatment and patients receiving PBO or ADA were re-randomized 1:1 to IXE Q2W or IXE Q4W through Week 52.

Results: Of 164 patients initially randomized to IXE, 146 (89%) completed Week 52. IXE Q4W and IXE Q2W led to persistent improvements in disease activity, function, objective inflammation (MRI and C-reactive protein), quality of life, health status, and overall functioning for up to 52 weeks (Figure and Table). For patients initially assigned to PBO or ADA, ASAS40 response showed a numerical increase upon switching to IXE (Table). Frequencies of treatment-emergent adverse events (AEs) were similar between IXE dosing regimens. Among patients with ≥1 dose of IXE (N=336), serious AEs occurred in 20 (6%) patients. There were no deaths and 11 (3%) patients discontinued due to AEs.

Conclusion: Persistent improvements in the signs and symptoms of r-axSpA were observed through Week 52 in patients who received continuous treatment with IXE. ASAS40 response rates at Week 52 were numerically similar between patients who received continuous treatment with IXE and patients who switched from ADA to IXE. No unexpected safety signals were observed through 52 weeks of treatment.
Reference: 1. van der Heijde et al. Lancet, 2018.

Disclosure: C. Wei, AbbVie, 2, 5, BMS, 2, 5, Celgene, 2, 5, Chugai, 5, Eisai, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Sanofi-Aventis, 5, TSH Biopharm, 2, 5, UCB Pharma, 2, 5; L. Gensler, AbbVie, 2, 5, Abbvie, 2, 9, Amgen, 2, Amgen, AbbVie and Novartis, 2, Center for Disease Control, 8, Division of Vaccine Injury Compensation, 8, Eli Lilly, 5, 9, Eli Lilly and Company, 9, Galapagos, 5, 9, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, 5, Janssen, 5, 9, Novartis, 2, 5, 9, Pfizer, 2, 9, Spondylitis Association of America, 6, Spondyloarthritis Research and Treatment Network (SPARTAN), 6, UCB, 2, 5, 9, UCB Pharma, 2, 9; J. Walsh, AbbVie, 2, 5, ABBVIE, NOVARTIS, LILLY, AMGEN, UCB, 5, Amgen, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, PFIZER, ABBVIE, 2, UCB, 5; R. Landewé, Abbott, 2, 5, 8, Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 8, Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, 2, AbbVie, 5, Abbvie, 5, 8, AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering- Plough, UCB, Wyeth, 5, Ablynx, 5, Amgen, 2, 5, 8, AstraZeneca, 5, BMS, 5, 8, Bristol Myers Squibb, 5, 8, Bristol-Myers Squibb, 5, Celgene, 5, 8, Centocor, 2, 5, 8, Director of Rheumatology Consultancy BV, which is a registered company under Dutch law, 6, Eli Lilly, 5, 8, Eli Lilly and Company, 5, Eli-Lilly, 5, 8, Galapagos, 5, 8, Gilead, 5, 8, GlaxoSmithKline, 5, Glaxo-Smith-Kline, 5, 8, Janssen, 5, 8, Merck, 5, 8, MSD, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Rheumatology bv, 4, Rheumatology Consultancy BV, 9, Roche, 2, 5, 8, Schering-Plough, 2, 5, 8, UCB, 5, 8, UCB Pharma, 2, 5, 8, Wyeth, 2, 5, 8; T. Tomita, AbbVie, 5, 8, Astellas, 5, 8, BMS, 5, 8, Eisai, 5, 8, Eli Lilly and Company, 5, 8, Janssen, 5, 8, Mitsubishi Tanabe, 5, 8, Novartis, 5, 8, Takeda, 5, 8, Pfizer, 5, 8; F. Zhao, Eli Lilly, 1, 3, 4, Eli Lilly and Company, 1, 3, 4; G. Gallo, Eli Lilly, 1, 3, 4, Eli Lilly and Company, 1, 3, 4; H. Carlier, Eli Lilly and Company, 1, 3, 4; M. Dougados, Pfizer, 2, 5, 8, Abbvie, 2, 5, 8, Eli Lilly and Company, 2, 5, 8, UCB, 2, 5, 8, Novartis, 2, 5, 8.

To cite this abstract in AMA style:

Wei C, Gensler L, Walsh J, Landewé R, Tomita T, Zhao F, Gallo G, Carlier H, Dougados M. Primary 1-Year Data of Ixekizumab in Biologic Disease-Modifying Anti-rheumatic Drug-Naïve Patients with Radiographic Axial Spondyloarthritis Including Data in Patients Rerandomized from Adalimumab to Ixekizumab [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/primary-1-year-data-of-ixekizumab-in-biologic-disease-modifying-anti-rheumatic-drug-naive-patients-with-radiographic-axial-spondyloarthritis-including-data-in-patients-rerandomized-from-adalimumab-to/. Accessed .

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