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 Constantin & 11 others Joyce E. Davidson, Bo Magnusson, Ricardo Russo, Luca Villa, Mariangela Rinaldi, Howard Rockette, Peter A. Lachenbruch, Frederick W. Miller, Jiri Vencovsky, Nicolino Ruperto,

Research output: Research - peer-reviewArticle

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Abstract

To develop response criteria for juvenile dermatomyositis (DM). We analysed 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. Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute per cent 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). The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute per cent change in core set measures, with thresholds for minimal, moderate, and major improvement.

LanguageEnglish (US)
Pages782-791
Number of pages10
JournalAnnals of the Rheumatic Diseases
Volume76
Issue number5
DOIs
StatePublished - May 1 2017

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Myositis
Rheumatology
Pediatrics
Juvenile dermatomyositis
Clinical Studies
Prednisone
Rituximab
Dermatomyositis
Natural History
Reproducibility of Results
Methotrexate
Cyclosporine
Physicians
Sensitivity and Specificity
Therapeutics
Surveys and Questionnaires

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

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. / Rider, Lisa G.; Aggarwal, Rohit; Pistorio, Angela; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Huber, Adam M.; Cimaz, Rolando; Cuttica, Rubén J.; De Oliveira, Sheila Knupp; Lindsley, Carol B.; Pilkington, Clarissa A.; Punaro, Marilynn; Ravelli, Angelo; Reed, Ann M.; Rouster-Stevens, Kelly; Van Royen-Kerkhof, Annet; Dressler, Frank; Magalhaes, Claudia Saad; Constantin, Tamás; Davidson, Joyce E.; Magnusson, Bo; Russo, Ricardo; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Ruperto, Nicolino; International Myositis Assessment and Clinical Studies Group.

In: Annals of the Rheumatic Diseases, Vol. 76, No. 5, 01.05.2017, p. 782-791.

Research output: Research - peer-reviewArticle

Rider, LG, Aggarwal, R, Pistorio, A, Bayat, N, Erman, B, Feldman, BM, Huber, AM, Cimaz, R, Cuttica, RJ, De Oliveira, SK, Lindsley, CB, Pilkington, CA, Punaro, M, Ravelli, A, Reed, AM, Rouster-Stevens, K, Van Royen-Kerkhof, A, Dressler, F, Magalhaes, CS, Constantin, T, Davidson, JE, Magnusson, B, Russo, R, Villa, L, Rinaldi, M, Rockette, H, Lachenbruch, PA, Miller, FW, Vencovsky, J, Ruperto, N & International Myositis Assessment and Clinical Studies Group 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' Annals of the Rheumatic Diseases, vol 76, no. 5, pp. 782-791. DOI: 10.1136/annrheumdis-2017-211401
Rider, Lisa G. ; Aggarwal, Rohit ; Pistorio, Angela ; Bayat, Nastaran ; Erman, Brian ; Feldman, Brian M. ; Huber, Adam M. ; Cimaz, Rolando ; Cuttica, Rubén J. ; De Oliveira, Sheila Knupp ; Lindsley, Carol B. ; Pilkington, Clarissa A. ; Punaro, Marilynn ; Ravelli, Angelo ; Reed, Ann M. ; Rouster-Stevens, Kelly ; Van Royen-Kerkhof, Annet ; Dressler, Frank ; Magalhaes, Claudia Saad ; Constantin, Tamás ; Davidson, Joyce E. ; Magnusson, Bo ; Russo, Ricardo ; Villa, Luca ; Rinaldi, Mariangela ; Rockette, Howard ; Lachenbruch, Peter A. ; Miller, Frederick W. ; Vencovsky, Jiri ; Ruperto, Nicolino ; International Myositis Assessment and Clinical Studies Group. / 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. In: Annals of the Rheumatic Diseases. 2017 ; Vol. 76, No. 5. pp. 782-791
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abstract = "To develop response criteria for juvenile dermatomyositis (DM). We analysed 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. Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute per cent 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). The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute per cent change in core set measures, with thresholds for minimal, moderate, and major improvement.",
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