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

Lisa G. Rider, Rohit Aggarwal, Angela Pistorio, Nastaran Bayat, Brian Erman, Brian M. Feldman, Adam M. Huber, Rolando Cimaz, Rubén J. Cuttica, Sheila Knupp de Oliveira, Carol B. Lindsley, Clarissa A. Pilkington, Marilynn Punaro, Angelo Ravelli, Ann M. Reed, Kelly Rouster-Stevens, Annet van Royen-Kerkhof, Frank Dressler, Claudia Saad Magalhaes, Tamás ConstantinJoyce E. Davidson, Bo Magnusson, Ricardo Russo, Luca Villa, Mariangela Rinaldi, Howard Rockette, Peter A. Lachenbruch, Frederick W. Miller, Jiri Vencovsky, Nicolino Ruperto, Lisa G. Rider, Nicolino Ruperto, Frederick W. Miller, Jiri Vencovsky, Rohit Aggarwal, Brian Erman, Nastaran Bayat, Angela Pistorio, Adam M. Huber, Brian M. Feldman, Paul Hansen, Howard Rockette, Peter A. Lachenbruch, Nicolino Ruperto, Lisa G. Rider, Maria Apaz, Suzanne Bowyer, Rolando Cimaz, Tamás Constantin, Susan Maillard, for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation

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Abstract

Objective: To develop response criteria for juvenile dermatomyositis (DM). Methods: We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. Results: Consensus was reached for a conjoint analysis–based continuous model with a total improvement score of 0–100, using absolute percent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91–98% for minimal improvement, 92–94% and 94–99% for moderate improvement, and 91–98% and 85–86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P = 0.009–0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (P < 0.006). Conclusion: The response criteria for juvenile DM consisted of a conjoint analysis–based model using a continuous improvement score based on absolute percent change in core set measures, with thresholds for minimal, moderate, and major improvement.

Original languageEnglish (US)
Pages (from-to)911-923
Number of pages13
JournalArthritis and Rheumatology
Volume69
Issue number5
DOIs
StatePublished - May 2017

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Rider, L. G., Aggarwal, R., Pistorio, A., Bayat, N., Erman, B., Feldman, B. M., Huber, A. M., Cimaz, R., Cuttica, R. J., de Oliveira, S. K., Lindsley, C. B., Pilkington, C. A., Punaro, M., Ravelli, A., Reed, A. M., Rouster-Stevens, K., van Royen-Kerkhof, A., Dressler, F., Magalhaes, C. S., ... for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation (2017). 2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Arthritis and Rheumatology, 69(5), 911-923. https://doi.org/10.1002/art.40060