The ASAS-OMERACT core domain set for axial spondyloarthritis

Area of Science:

• Rheumatology
• Clinical Trial Methodology
• Outcome Measurement

Background:

• The existing core outcome set for ankylosing spondylitis (AS) has seen minimal updates over two decades.
• Significant advancements in AS research necessitate an updated core outcome set.

Purpose of the Study:

• To update the ASAS-OMERACT core outcome set for AS to the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).

Main Methods:

• An international working group followed OMERACT and COMET guidelines.
• Candidate domains were identified via systematic literature review and qualitative studies.
• A 3-round Delphi survey with patients and experts refined domain selection, followed by ASAS consensus and OMERACT endorsement.

Main Results:

• The updated axSpA core outcome set includes 7 mandatory domains for all trials: disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events.
• Three additional domains (extra-musculoskeletal manifestations, peripheral manifestations, structural damage) are mandatory for disease-modifying therapies and optional for symptom-modifying therapies.
• Three further domains (spinal mobility, sleep, work and employment) are optional for all trials.

Conclusions:

• The ASAS-OMERACT core domain set for AS has been successfully updated for axial spondyloarthritis (axSpA).
• The subsequent phase involves selecting specific instruments to measure each defined domain.