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Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated
Laura C Coates1, Sonya Abraham2, William Tillett3
1University of Oxford, Oxford, UK.
Objective:
To examine the concurrent validity and discrimination of criteria for modified minimal disease activity (MDA) in peripheral spondyloarthritis (SpA) following filter principles of Outcome Measures in Rheumatology (OMERACT) and to determine predictors of modified MDA response.
Methods:
Four modified MDA versions were derived in the ABILITY-2 study using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index or the Leeds Enthesitis Index (LEI) while excluding psoriasis. To assess concurrent validity, modified MDA versions were correlated with Peripheral Spondyloarthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score showing inactive disease (ASDAS ID), and physician global assessment of disease activity. Treatment discrimination was assessed between adalimumab and placebo at week 12. Multiple logistic regression was used to determine baseline predictors of long-term modified MDA responses and sustained modified MDA.
Results:
The 4 modified MDA versions showed a stronger positive correlation with PSpARC remission (rtet > 0.95) versus ASDAS ID (rtet > 0.75) at week 12 and years 1-3 and were able to show discrimination (P < 0.001). Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all 4 versions of modified MDA. Approximately 40-60% of patients treated with adalimumab achieved modified MDA using the LEI or SPARCC enthesitis index at years 1-3. Achieving modified MDA response after 12 weeks of adalimumab treatment was a robust positive predictor of attaining long-term modified MDA through 3 years (odds ratio [OR] 11.38-27.13 for modified MDA using the LEI; OR 17.98-37.85 for modified MDA using the SPARCC enthesitis index).
Conclusion:
All 4 versions of modified MDA showed concurrent validity and discriminated well between adalimumab and placebo treatment groups. Early modified MDA response is a more consistent predictor of long-term modified MDA achievement than baseline characteristics. The 5 of 6 versions of modified MDA could be an appropriate treatment target in patients with peripheral SpA.
Insights
Modified minimal disease activity (MDA) criteria effectively assess peripheral spondyloarthritis (SpA) treatment response. Early achievement of modified MDA predicts long-term success, making it a valuable treatment target for peripheral SpA patients.
Area of Science:
- Rheumatology
- Clinical Trial Analysis
- Outcome Measurement
Background:
- Peripheral spondyloarthritis (SpA) requires validated measures for disease activity.
- Minimal Disease Activity (MDA) is a key target, but modified criteria are needed for peripheral SpA.
- Outcome Measures in Rheumatology (OMERACT) principles guide the development of new assessment tools.
Purpose of the Study:
- To evaluate the concurrent validity and discriminative ability of modified MDA criteria in peripheral SpA.
- To identify predictors of achieving and sustaining a modified MDA response.
- To align with OMERACT filter principles for robust outcome measures.
Main Methods:
- Four modified MDA versions were developed using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index or Leeds Enthesitis Index (LEI), excluding psoriasis.
- Concurrent validity was assessed by correlating modified MDA with PSpARC remission, ASDAS inactive disease, and physician global assessment.
- Treatment discrimination between adalimumab and placebo was evaluated at week 12, with logistic regression identifying predictors of long-term response.
Main Results:
- All four modified MDA versions demonstrated strong concurrent validity and discriminated effectively between adalimumab and placebo groups.
- Patients receiving adalimumab showed significantly higher rates of achieving modified MDA compared to placebo at week 12.
- Achieving modified MDA by week 12 was a strong predictor of sustained modified MDA achievement through 3 years.
Conclusions:
- The evaluated modified MDA criteria possess concurrent validity and discriminative ability in peripheral SpA.
- Early modified MDA response is a more reliable predictor of long-term outcomes than baseline patient characteristics.
- Several modified MDA versions are suitable as treatment targets for patients with peripheral SpA.
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