2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

Published

Journal Article

OBJECTIVE: To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). METHODS: Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. RESULTS: Consensus was reached for a conjoint analysis-based continuous model using absolute percent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (P < 0.001). CONCLUSION: The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

Full Text

Duke Authors

Cited Authors

  • Aggarwal, R; Rider, LG; Ruperto, N; Bayat, N; Erman, B; Feldman, BM; Oddis, CV; Amato, AA; Chinoy, H; Cooper, RG; Dastmalchi, M; Fiorentino, D; Isenberg, D; Katz, JD; Mammen, A; de Visser, M; Ytterberg, SR; Lundberg, IE; Chung, L; Danko, K; García-De la Torre, I; Song, YW; Villa, L; Rinaldi, M; Rockette, H; Lachenbruch, PA; Miller, FW; Vencovsky, J; International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation,

Published Date

  • May 2017

Published In

Volume / Issue

  • 69 / 5

Start / End Page

  • 898 - 910

PubMed ID

  • 28382787

Pubmed Central ID

  • 28382787

Electronic International Standard Serial Number (EISSN)

  • 2326-5205

Digital Object Identifier (DOI)

  • 10.1002/art.40064

Language

  • eng

Conference Location

  • United States