Spondyloarthritis & psoriatic arthritis
Comparison of the established ASAS definition and preliminary proposed data-driven cut-offs for inflammatory and structural magnetic resonance imaging (MRI) lesions in the sacroiliac joints for eligibility of patients with nonradiographic axial spondyloarthritis in clinical trials
Authors' conclusion
Patients fulfilling ED or PD of a positive MRI-SIJ showed similar baseline characteristics and clinical outcomes at week 16. In this analysis, PD did not outperform ED in the identification of patients for a clinical trial in nr-axSpA.
Study context
- Population
- Patients with nonradiographic axial spondyloarthritis (nr-axSpA) in COAST-X (ixekizumab (IXE) or placebo up to 52 weeks)
- Comparison
- 2009 ASAS MRI-SIJ established definition (ED) vs 2021 preliminary proposed data-driven definitions (PD) for eligibility, in IXE and placebo arms
- Primary endpoint
- Patient characteristics and clinical outcomes (ASAS40, BASDAI50, mean BASDAI change, Axial Spondyloarthritis Disease Activity Score (ASDAS) clinically important improvement, ASDAS disease states) by definition, reported descriptively
- Follow-up
- Week 16
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, descriptive
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Descriptive
Primary result
As reported in the abstract
Clinical outcomes at week 16 by MRI-SIJ definition
- Within each treatment arm, outcomes similar across all ED or PD MRI-SIJ+ cut-off subgroups
- Outcomes in subgroups fulfilling ED but not PD and vice versa slightly lower than ED or PD MRI-SIJ+ subgroups
- Post hoc analysis
- Reported descriptively
Further findings
Baseline demographics and disease characteristics
- Balanced between all ED or PD MRI-SIJ+ cut-off subgroups
Original publication
Comparison of the established ASAS definition and preliminary proposed data-driven cut-offs for inflammatory and structural MRI lesions in the sacroiliac joints for eligibility of patients with nonradiographic axial spondyloarthritis in clinical trials. Ann Rheum Dis. Published 25 June 2026. doi:10.
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