The ASAS-OMERACT core domain set for axial spondyloarthritis

Navarro-Compán, V., Boel, A., Boonen, A., Mease, P., Landewé, R., Kiltz, U., Dougados, M., Baraliakos, X., Bautista-Molano, W., Carlier, H., Chiowchanwisawakit, P., Dagfinrud, H., de Peyrecave, N., El-Zorkany, B., Fallon, L., Gaffney, K. ORCID: https://orcid.org/0000-0002-7863-9176, Garrido-Cumbrera, M., Gensler, L. S., Haroon, N., Kwan, Y. H., Machado, P. M., Maksymowych, W. P., Poddubnyy, D., Protopopov, M., Ramiro, S., Shea, B., Song, I. H., van Weely, S. and van der Heijde, D. (2021) The ASAS-OMERACT core domain set for axial spondyloarthritis. Seminars in Arthritis and Rheumatism, 51 (6). pp. 1342-1349. ISSN 0049-0172

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Abstract

Background: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary.  Objective: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).  Methods: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies.  Results: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials.  Conclusion: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Item Type: Article
Additional Information: Funding Information: V. Navarro-Compán: Research grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB. A. Boel has no competing interests to declare. A. Boonen: Research grants from AbbVie and Novartis and honoraria for boards or lectures form AbbVie, Galapagos and Lilly. R. Landewé: Honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Eli-Lilly, Novartis, Pfizer, UCB Pharma. Director of Rheumatology Consultancy BV. U. Kiltz: Grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. M. Dougados: Consulting fees from Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB Pharma. W. Bautista-Molano: Research speaker´s fees from Janssen, Lilly, Novartis, Pfizer, and Biopas. X. Baraliakos: Consulting fees from AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB. P. Chiowchanwisawakit: Research grants/honoraria from Novartis, Pfizer, Zuellig Pharma, Janssen. N. de Peyrecave: Employee of UCB Pharma. B. Elzorkany: Consultancy, research grants, and speaker's fees from: AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis, and Servier. L. Fallon: Employee and shareholder of Pfizer Inc. K. Gaffney: Research grants from AbbVie, Lilly, Novartis, Pfizer, UCB. Consulting fees: AbbVie, Celltrion, Celgene, Gilead, Lilly, MSD, Novartis, Pfizer, UCB: Director Spondyloarthritis Academy (SPATE UK). LS. Gensler: Research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB. N. Haroon: Consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PM. Machado: Consulting/speaker's fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WP. Maksymowych: Consulting fees from Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer, UCB; Research and/or Educational Grants Abbvie, Novartis, Pfizer; Chief Medical Officer CARE Arthritis Limited. S. Ramiro: Research grants from Galapagos, MSD, Novartis, Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. D. Poddubnyy: Research support from AbbVie, Lilly, MSD, Novartis, and Pfizer. Consulting fees from: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB. Speaker fees from: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB. I-H. Song: Employee of AbbVie, Immunology Clinical Development, USA. D. van der Heijde: Consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma. Director of Imaging Rheumatology bv. Funding Information: We would like to thank Shawna Grosskleg for her contribution to the project. We would like to thank all patients from the Spondylitis Association of America, Canadian Spondylitis Association and National Axial Spondyloarthritis Society for their participation in the Delphi survey. We would also like to thank all ASAS members and the participants of the OMERACT workshop for their participation in the project. PMM is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). Funding Information: VN-C and DvdH wrote the first draft of the manuscript. All authors participated actively in the project. All authors critically reviewed the manuscript for important intellectual contribution and approved the final version. The Assessment of SpondyloArthritis international Society (ASAS) funded Anne Boel and Victoria Navarro-Comp?n to work on the project to update the core outcome set. We would like to thank Shawna Grosskleg for her contribution to the project. We would like to thank all patients from the Spondylitis Association of America, Canadian Spondylitis Association and National Axial Spondyloarthritis Society for their participation in the Delphi survey. We would also like to thank all ASAS members and the participants of the OMERACT workshop for their participation in the project. PMM is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). Disclaimer: The views expressed here are those of the authors and do not necessarily represent the views of the (UK) National Health Service (NHS), the National Institute for Health Research (NIHR), or the (UK) Department of Health. Publisher Copyright: © 2021 Elsevier Inc.
Uncontrolled Keywords: ankylosing spondylitis,asas,axial spondyloarthritis,core outcome set,domain,omeract,outcome,rheumatology,anesthesiology and pain medicine ,/dk/atira/pure/subjectarea/asjc/2700/2745
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 15 Jul 2022 11:30
Last Modified: 12 Aug 2022 02:41
URI: https://ueaeprints.uea.ac.uk/id/eprint/86176
DOI: 10.1016/j.semarthrit.2021.07.021

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