Ixekizumab Significantly Improves Self-reported Overall Health as Measured by Short-Form-36 in Patients with Active Non-radiographic Axial Spondyloarthritis: 16- and 52-Week Results of a Phase 3 Randomized Trial (COAST-X)

Jessica Walsh¹, Marina Magrey ², Uta Kiltz ³, Xenofon Baraliakos ⁴, Maggie Weng ⁵, Theresa Hunter ⁶, Xiaoqi Li ⁶, Luis Leon ⁷, David Sandoval ⁷ and Kentaro Inui ⁸, ¹Division of Rheumatology, University of Utah, Salt Lake City, UT, ²Division of Rheumatology, The MetroHealth System and School of Medicine, Case Western Reserve University, Cleveland, OH, ³Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany, Herne, Germany, ⁴Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, ⁵National Cheng-Kung University Medical Center, Tainan, Taiwan (Republic of China), ⁶Eli Lilly and Company, Indianapolis, ⁷Eli Lilly and Company, Indianapolis, IN, ⁸Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: quality of life, SF-36 and axSpA

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: Previous studies have determined that axial spondyloarthritis (axSpA) significantly impairs patients’ health-related quality of life (HRQoL).¹ The patients with nr-axSpA have the same disease burden as patients with r-axSpA.² We report the HRQoL results at Weeks 16 and 52 in patients with nonradiographic (nr)-axSpA treated with Ixekizumab (IXE).

Methods: COAST-X (NCT02757352) is a Phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group, clinical trial. Enrolled patients were adults with active nr-axSpA as per the Assessment of SpondyloArthritis international Society (ASAS) criteria, with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and total back pain ≥4, and with no prior treatment with biologic agents. Patients who fulfilled the definition of sacroiliitis per modified New York (mNY) criteria were excluded. Patients were randomized in a 1:1:1 ratio to subcutaneous PBO, 80 mg IXE every 4 (Q4W) or 2 weeks (Q2W) up to Week 52. For patients who needed rescue and switched to IXE 80 mg Q2W, observations after rescue were considered as missing. Changes from baseline in SF-36 up to Week 52 were analyzed by mixed model for repeated measures without imputation for missing data.

Results: From baseline to Week 16, Physical Component Summary (PCS) significantly differed between PBO and IXE Q4W (p=0.013), and IXE Q2W (p=0.015) groups. Significant improvement over PBO was noted as early as Week 4 (IXE Q4W: p=0.015; IXE Q2W: p< 0.001) and it was maintained until Week 52 (IXE Q4W: p=0.012; IXEQ2W: p=0.006). Since the baseline MCS values were within the normal range across all treatment groups, no significant improvements were observed from baseline in Mental Component Summary (MCS) at Week 16 or Week 52 compared with the placebo group.

Conclusion: Patients with nr-axSpA treated with IXE demonstrated an improvement over PBO in self-reported HRQoL at Week 16 and throughout Week 52 as measured by SF-36. The improvement was significant for PCS and some domains. Significant improvements were also observed as early as the first time the instrument was applied (Week 4).

Study Sponsor Statement: This study was supported by Eli Lilly and Company. Lilly participated in the study design, data collection, and the analysis and reporting of study results.

References:

Kwan, et al. Qual Life Res. 2018;27:2321-2327.
Zhao SS, et al. Rheumatology (Oxford). 2019. doi: 10.1093/rheumatology/kez171.

Figure ACR 2019

Table ACR 2019

Disclosure: 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; M. Magrey, AbbVie, 2, Abbvie, 2, Abbvie, UCB and Amgen, 2, Amgen, 2, 5, Eli Lilly, 5, Eli Lilly and Company, 5, Eli Lily, Novartis, 5, Novartis, 5, 9, UCB, 2, UCB Pharma, 2; U. Kiltz, AbbVie, 2, 5, 8, ABBVIE, NOVARTIS, CHUGAI, JANSEN, MSD, UCB, 8, ABBVIE, NOVARTIS, LILLY,BIOCAD, GRUNENTHAL,UCB, 5, ABBVIE, NOVARTIS, PFIZER,BIOGEN, 2, Biocad, 2, 5, Biogen, 2, 5, Chugai, 2, 5, 8, Eli Lilly, 2, 5, Eli Lilly and Company, 5, Grünenthal, 2, 5, 8, Janssen, 8, Jasnssen, 2, 5, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, Roche, 2, 5, 8, UCB, 2, 5, 8; X. Baraliakos, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, BMS, 2, 5, 8, 9, Bristol-Myers Squibb, 2, 5, 8, Celgene, 2, 5, 8, 9, Chugai, 2, 5, 8, 9, Janssen, 2, 5, 8, 9, Lilly, 2, 8, 9, Merck, 2, 5, 8, MSD, 2, 5, 8, 9, Novartis, 2, 5, 8, 9, Novatis, 2, 5, 8, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9, UCB Pharma, 2, 5, 8, Werfen, 2, 5, 8; M. Weng, None; T. Hunter, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; X. Li, Eli Lilly and Company, 1, 3; L. Leon, Eli Lilly, 1, 3; D. Sandoval, Eli Lilly, 1, 3, Eli Lilly and Company, 1, 3; K. Inui, Eli Lilly Japan, 2, 8, Pfizer Japan, 2, 8, Astellas Pharma, 2, 8, AbbVie GK, 2, 8, Eisai, 2, 8, Takeda, 8, Mitsubishi Tanabe Pharma, 8, Novartis Pharma, 2, 8, Chugai Pharma, 2, 8, Nippon Kayaku, 2, Bristol-Myers Squibb, 2, Janssen Pharma, 8, Ono Pharma, 8, Nippon Zoki Pharma, 8, Asahi Kasei Pharma, 8, Celgine, 8, Kyowa hakko Kirin, 8.

To cite this abstract in AMA style:

Walsh J, Magrey M, Kiltz U, Baraliakos X, Weng M, Hunter T, Li X, Leon L, Sandoval D, Inui K. Ixekizumab Significantly Improves Self-reported Overall Health as Measured by Short-Form-36 in Patients with Active Non-radiographic Axial Spondyloarthritis: 16- and 52-Week Results of a Phase 3 Randomized Trial (COAST-X) [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/ixekizumab-significantly-improves-self-reported-overall-health-as-measured-by-short-form-36-in-patients-with-active-non-radiographic-axial-spondyloarthritis-16-and-52-week-results-of-a-phase-3-rando/. Accessed .

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