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

Author:

Baraliakos XenofonORCID,Machado Pedro MORCID,Bauer Lars,Hoepken Bengt,Kim Mindy,Kumke Thomas,Tham Rachel,Rudwaleit MartinORCID

Abstract

BackgroundA 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.MethodsBaseline 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.ResultsAcross 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.ConclusionThis 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 numberNCT02505542.

Funder

UCB Pharma

Publisher

BMJ

Reference18 articles.

1. Axial spondyloarthritis

2. Evaluation of Diagnostic Criteria for Ankylosing Spondylitis

3. Axial spondyloarthritis: concept, construct, classification and implications for therapy;Robinson;Nat Rev Rheumatol,2021

4. Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE;Landewé;Rheumatol Ther,2020

5. Administration FaD . CIMZIA (certolizumab pegol). Product information: UCB, Inc., Smyrna, GA, USA. Available: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.Pdf [Accessed 16 Aug 2023].

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