Poddubnyy Denis, Navarro-Compán Victoria, Torgutalp Murat, Arends Suzanne, Aydin Sibel Zehra, Battista Simone, van den Bosch Filip, Bundy Christine, Cauli Alberto, Davies Jo, Dougados Maxime, Duruöz Tuncay, El-Zorkany Bassel, Fong Warren, van Gaalen Floris, Garcia-Salinas Rodrigo, Garrido Cumbrera Marco, Géher Pál, Gensler Lianne, Grazio Simeon, Huang Feng, Kishimoto Mitsumasa, Landewé Robert, Leung Ying Ying, Machado Pedro M, Marzo-Ortega Helena, Meghnathi Bhowmik, Molto Anna, Nikiphorou Elena, Ramiro Sofia, Rudwaleit Martin, Saad Carla G S, Sepriano Alexandre, Wei James, Baraliakos Xenofon, van der Heijde Désirée
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.
Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain.
Ann Rheum Dis. 2025 Apr;84(4):538-546. doi: 10.1016/j.ard.2025.01.035. Epub 2025 Feb 14.
To develop a consensus-based expert definition of difficult-to-manage (D2M) axial spondyloarthritis (axSpA), incorporating treatment-refractory (TR) disease.
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.
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.
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.
制定一个基于共识的、纳入治疗难治性（TR）疾病的难以管理（D2M）轴性脊柱关节炎（axSpA）专家定义。
2022年进行了一项文献综述，以确定先前研究中D2M/TR axSpA的潜在定义，随后在2022年和2023年进行了两轮德尔菲共识过程，以确定D2M axSpA的组成部分。根据德尔菲过程的结果，制定了D2M axSpA定义草案，并提交给专家特别工作组（包括患者代表），随后于2024年1月提交给国际脊柱关节炎评估协会（ASAS）成员以供认可。
就一个D2M定义达成了共识，该定义涵盖治疗失败（根据ASAS-欧洲风湿病协会联盟建议进行治疗，且≥2种具有不同作用机制的生物或靶向合成抗风湿药物治疗失败，除非有禁忌）、疾病控制不佳，以及风湿病学家诊断为axSpA的患者中医生或患者对问题体征/症状的认可。这个定义代表了一个广泛的概念，包括导致治疗结果不理想的各种原因。TR axSpA包含在D2M定义中，但需要有治疗失败史、炎症活动的客观体征，以及排除无反应的非炎症性原因。纳入TR疾病的拟议D2M定义在2024年1月的ASAS年会上获得认可，89%的选票（109/123）赞成该定义。
ASAS的D2M axSpA定义（包括TR疾病）有助于识别有未满足需求的患者，为针对这种情况的进一步研究及其临床护理改善铺平道路。
