Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles
Authors' conclusion
The ACR-EULAR MRC perform consistently across multiple studies, supporting its further use as an efficacy end point in JDM trials.
Study context
- Population
- JDM patients from the Rituximab in Myositis trial, the PRINTO JDM trial and consensus patient profiles457 with IMACS core set measures (CSMs), 380 with PRINTO CSMs
- Participants
- 48 / 139 / 273
- Comparison
- Rituximab in Myositis trial vs PRINTO JDM trial vs Consensus patient profiles
- Rituximab in Myositis trialn = 48
- PRINTO JDM trialn = 139
- Consensus patient profilesn = 273
- Outcome
- Improvement by 2016 ACR-EULAR MRC
Methodological detailssecondary analysis of trial data and consensus patient profiles, Sign test, Wilcoxon tests with Bonferroni adjustment, Spearman correlation, weighted Cohen's kappa
- Secondary analysis of trial data and consensus patient profiles
- Sign test
- Wilcoxon tests with Bonferroni adjustment
- Spearman correlation
- Weighted Cohen's kappa
Recommendations
As reported in the abstract
- Minimal improvement
- 9-13%
- Moderate improvement
- 19-23%
- Major improvement
- 41-50%
- Median CSMs worsened, minimal improvement
- 0-1
- Median CSMs worsened, moderate/major improvement
- zero
- Improved by myositis response criteria (MRC) with improved muscle strength
- 94-95%
- Improved by MRC with improvement in ≥1 patient-reported CSM
- 93-95%
- Agreement of physician-rated change with MRC categories (weighted kappa), moderate-to-substantial
- 0.5-0.7
Original publication
Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles. Rheumatology (Oxford). Published 17 March 2023. doi:10.
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