Comparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis.

Autor:	Baraliakos X; Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Germany baraliakos@me.com., Machado PM; Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London, UK.; Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK.; Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, UK., Bauer L; UCB Pharma, Monheim am Rhein, Germany., Hoepken B; UCB Pharma, Monheim am Rhein, Germany., Kim M; UCB Pharma, Smyrna, Georgia, USA., Kumke T; UCB Pharma, Monheim am Rhein, Germany., Tham R; UCB Pharma, Slough, UK., Rudwaleit M; Klinikum Bielefled, University of Bielefeld, Bielefeld, Germany.
Jazyk:	angličtina
Zdroj:	RMD open [RMD Open] 2024 Sep 03; Vol. 10 (3). Date of Electronic Publication: 2024 Sep 03.
DOI:	10.1136/rmdopen-2023-003886
Abstrakt:	Background: A consensus definition for active sacroiliitis by MRI, mentioned in the Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis (axSpA), was published in 2009 and included a qualitative and quantitative MRI cut-off component. In 2021, updates to the quantitative component were preliminarily proposed. This post hoc analysis of part A of the phase 3 open-label C-OPTIMISE study (NCT02505542) explores the differences by applying the 2009 and preliminary 2021 inflammatory cut-offs on clinical outcomes of axSpA patients treated with certolizumab pegol. Methods: Baseline MRI scans were used to classify 657 patients as MRI+ or MRI- according to the quantitative components of the 2009 and preliminary 2021 MRI cut-offs for inflammatory lesions. Clinical outcomes, including ASAS ≥40% improvement (ASAS40), Ankylosing Spondylitis Disease Activity Score and Bath Ankylosing Spondylitis Disease Activity Index, were reported to week 48. Results: Across all analysed outcomes, 2009 MRI+ and preliminary 2021 MRI+ subgroups showed similar results. Notably, clinical outcomes for the discordant group (2009 MRI+but preliminary 2021 MRI- group; 53/657 [8.1%]) were close to those seen in MRI- patients according to either 2009 or preliminary 2021 inflammatory cut-offs, and notably different from the totality of MRI+ subgroups. Conclusion: This analysis suggests that the preliminary 2021 cut-offs for MRI inflammatory lesions may slightly increase the specificity of the quantitative part of the 2009 MRI inflammatory lesion definition. The effects of the updated MRI cut-offs need to be assessed on the basis of efficacy outcomes and with the inclusion of aspects of structural changes. Trial Registration Number: NCT02505542. Competing Interests: Competing interests: XB: Speakers’ bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma; Paid instructor for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma; Consultant of AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma. PMM: Personal fees from: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GSK, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB Pharma. LB, BH: Employee and stockholder of UCB Pharma. MK, TK: Employee of UCB Pharma. RT: Veramed statistical consultant for UCB Pharma. MR: Speakers’ bureau from: AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma; Consultant of AbbVie, Eli Lilly, Novartis, UCB Pharma. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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