The Assessment of SpondyloArthritis International Society (ASAS) Consensus-Based Expert Definition of Difficult-to-Manage, including Treatment-Refractory, Axial Spondyloarthritis.

Tuncay Duruöz, Bhowmik Meghnathi, Carla G S Saad, Feng Huang, Denis Poddubnyy, Alberto Cauli, Alexandre Sepriano, Sibel Zehra Aydin, Jo Davies, Simeon Grazio, Floris van Gaalen, Rodrigo Garcia-Salinas, Marco Garrido Cumbrera, Lianne Gensler, Ying Ying Leung, Helena Marzo-Ortega, Martin Rudwaleit, James Wei, Maxime Dougados, Murat Torgutalp, Mitsumasa Kishimoto, Bassel El-Zorkany, Robert Landewé, Pál Géher, Anna Molto, Suzanne Arends, Warren Fong, Sofia Ramiro, Désirée van der Heijde, Xenofon Baraliakos, Filip van den Bosch, Pedro M Machado, Victoria Navarro-Compán, Simone Battista, Elena Nikiphorou, Christine Bundy

Journal: Annals of the rheumatic diseases 2025;84(4):538-546

PMID: 39955166

Abstract

OBJECTIVES

To develop a consensus-based expert definition of difficult-to-manage (D2M) axial spondyloarthritis (axSpA), incorporating treatment-refractory (TR) disease.

METHODS

A literature review was conducted in 2022 to identify potential definitions for D2M/TR axSpA from prior studies, followed by a 2-round Delphi consensus process conducted in 2022 and 2023 to identify components of D2M axSpA. Based on the results of the Delphi process, a draft of the D2M axSpA definition was developed and presented to the expert task force, including patient representation, and, subsequently, to the Assessment of SpondyloArthritis International Society (ASAS) membership for endorsement in January 2024.

RESULTS

Consensus was reached on a D2M definition encapsulating treatment failure (treatment according to the ASAS-European Alliance of Associations for Rheumatology recommendations and failure of ≥2 biological or targeted synthetic disease-modifying antirheumatic drugs with different mechanisms of action unless contraindicated), suboptimal disease control, and physician or patient acknowledgement of problematic signs/symptoms in patients diagnosed with axSpA by the rheumatologist. This definition represents a broad concept that includes various reasons that lead to an unsatisfactory treatment outcome. TR axSpA is covered by the D2M definition but requires a history of treatment failure, the presence of objective signs of inflammatory activity, and the exclusion of noninflammatory reasons for nonresponse. The proposed D2M definition incorporating TR disease was endorsed by ASAS at the annual meeting in January 2024, with 89% votes (109/123) in favour of it.

CONCLUSIONS

The ASAS D2M axSpA definition, including TR disease, allows for identifying patients with unmet needs, paving the way for further research in this condition and its clinical care improvement.

Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.

Address: Division of Rheumatology, Department of Medicine, University of Toronto and University Health Network, Toronto, ON, Canada; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. Electronic address: [email protected].; Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain.; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Division of Rheumatology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada.; Centre for Human Movement and Rehabilitation, School of Health and Society, University of Salford, Salford, Greater Manchester, UK.; Department of Rheumatology, Ghent University, Ghent University Hospital, Ghent, Belgium.; School of Healthcare Sciences, Cardiff University, Wales, UK.; Rheumatology Unit, Department of Medicine and Public Health, AOU and University of Cagliari, Cagliari, Italy.; Axial Spondyloarthritis International Federation (ASIF), London, UK.; Department of Rheumatology, Hôpital Cochin, University Paris Cité, Paris, France.; PMR Department, Rheumatology Division, Marmara University School of Medicine, Istanbul, Turkey.; Department of Rheumatology, Cairo University, Cairo, Egypt.; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.; Rheumatology Unit, Hospital Italiano de La Plata - Universidad Nacional de La Plata, La Plata, Argentina.; Health & Territory Research (HTR), Universidad de Sevilla, Seville, Spain.; Semmelweis University, Budapest, Hungary.; Division of Rheumatology, University of California San Francisco, San Francisco, CA, USA.; Department of Rheumatology, Physical and Rehabilitation Medicine, Clinical University Centre, Sestre Milosrdnice, Zagreb, Croatia.; Department of Rheumatology and Immunology, Chinese PLA General Hospital, Beijing, China.; Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.; Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands.; Department of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore.; Department of Neuromuscular Diseases, UCL Queen Square Institute of Neurology, University College London, London, UK; Department of Rheumatology, Division of Medicine, University College London, London, UK.; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.; Department of Rheumatology & Immunology, SVP Hospital & Smt. NHL Municipal Medical College, Ahmedabad, India; Department of Rheumatology, Marengo CIMS Hospital & RheumaCARE, Ahmedabad, India.; Rheumatology Department Cochin Hospital, APHP, INSERM U-1153, Centre de Recherche en Epidémiologie et Statistiques, Université Paris Cité, Paris, France.; Rheumatology Department, King's College Hospital, Centre for Rheumatic Diseases, Centre for Education, King's College London, London, UK.; Department of Internal Medicine and Rheumatology, Klinikum Bielefeld, University of Bielefeld, Bielefeld, Germany.; Rheumalogy Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; NOVA Medical School, UNL, Lisbon, Portugal.; Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan; Department of Nursing, Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan.; Rheumazentrum Ruhrgebiet, Herne and Ruhr-University, Bochum, Germany.; Department of Rheumatology, Leiden University, Leiden, The Netherlands.

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