Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years
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Objective. To evaluate the long-term effect of ixekizumab (IXE) on radiographic changes in the spine in patients with radiographic axial spondyloarthritis (r-axSpA) by measuring change from baseline through 2 years in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS), and to identify potential predictors of progression. Methods. This study evaluates patients from COAST-V (ClinicalTrials.gov: NCT02696785, biologic disease-modifying antirheumatic drug–naïve) and COAST-W (NCT02696798, tumor necrosis factor inhibitor–experienced) who had mSASSS data at baseline in the originating studies and 108 weeks after baseline in the extension study COAST-Y (NCT03129100). We examined the proportion of patients who did not have spinal radiographic progression through 2 years (108 weeks) of treatment with IXE (80 mg every 2 or 4 weeks) and the change from baseline to year 2 in mSASSS. Potential predictors of spinal radiographic progression were also evaluated. Results. Among patients with evaluable radiographs who were originally assigned to IXE (n = 230), mean (SD) change in mSASSS from baseline at year 2 was 0.3 (1.8). The proportion of nonprogressors over 2 years was 89.6% if defined as mSASSS change from baseline < 2 and 75.7% if defined as mSASSS change from baseline ≤ 0. Predictors of structural progression at year 2 (mSASSS change > 0) were age ≥ 40, baseline syndesmophytes, HLA-B27 positivity, and male sex. Week 52 inflammation in Spondyloarthritis Research Consortium of Canada spine was also a predictor of radiographic progression at year 2 in patients with magnetic resonance imaging data in COAST-V (n = 109). Conclusion. The majority of patients with r-axSpA receiving IXE had no radiographic progression in the spine through 2 years of treatment. Predictors were generally consistent with previous studies.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Rheumatology |
| Vol/bind | 49 |
| Udgave nummer | 3 |
| Sider (fra-til) | 265-273 |
| Antal sider | 9 |
| ISSN | 0315-162X |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
This study was funded by Eli Lilly and Company (Indianapolis, Indiana, USA). 1D. van der Heijde, MD, Department of Rheumatology, Leiden University Medical Centre, Leiden, the Netherlands; 2M. Østergaard, MD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; 3J.D. Reveille, MD, Division of Rheumatology and Clinical Immunogenetics, University of Texas–McGovern Medical School, Houston, Texas, USA; 4X. Baraliakos, MD, Ruhr-University Bochum, Bochum, Germany, and Rheumazentrum Ruhrgebiet, Herne, Germany; 5A. Kronbergs, PhD, D.M. Sandoval, MD, X. Li, PhD, H. Carlier, MD, D.H. Adams, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA; 6W.P. Maksymowych, MD, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. DvdH has received consulting fees and/or speaking fees and/or honoraria from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB Pharma, and is the Director of Imaging Rheumatology BV. MØ has received consulting fees and/or speaking fees and/or honoraria from AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB. JDR has received consulting fees and/or speaking fees and/or honoraria from Eli Lilly and UCB. XB has received consulting fees and/or speaking fees and/or honoraria from AbbVie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Roche, and UCB. AK, DMS, XL, HC, and DHA are current employees of Eli Lilly and Company and own stock or stock options in Eli Lilly and Company. WPM has received consulting fees and/or speaking fees and/or honoraria from AbbVie, BMS, Boehringer Ingelheim, Galapagos, Gilead, Eli Lilly, Novartis, Pfizer, and UCB. Address correspondence to Dr. D. van der Heijde, Department of Rheumatology, Leiden University Medical Centre, P.O. Box 9600, 2300 RC Leiden, the Netherlands. Email: mail@dvanderheijde.nl. Accepted for publication on November 19, 2021.
Publisher Copyright:
© 2022 The Journal of Rheumatology
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