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. Issue 5 (6th April 2017)

• Record Type: Journal Article
• Authors: 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
• Other Names: Rider Lisa G. investigator.; Ruperto Nicolino investigator.; Miller Frederick W. investigator.; Vencovsky Jiri investigator.; Aggarwal Rohit investigator.; Erman Brian investigator.; Bayat Nastaran investigator.; Pistorio Angela investigator.; Huber Adam M. investigator.; Feldman Brian M. investigator.; Hansen Paul investigator.; Rockette Howard investigator.; Lachenbruch Peter A. investigator.; Ruperto Nicolino investigator.; Rider Lisa G. investigator.; Apaz Maria investigator.; Bowyer Suzanne investigator.; Cimaz Rolando investigator.; Constantin Tamás investigator.; Curran Megan investigator.; Davidson Joyce investigator.; Feldman Brian M. investigator.; Griffin Thomas investigator.; Huber Adam H. investigator.; Jones Olcay investigator.; Kim Susan investigator.; Lang Bianca investigator.; Lindsley Carol investigator.; Lovell Daniel investigator.; Saad Magalhaes Claudia investigator.; Pachman Lauren M. investigator.; Pilkington Clarissa investigator.; Ponyi Andrea investigator.; Punaro Marilynn investigator.; Quartier Pierre investigator.; Ramanan Athimalaipet V. investigator.; Ravelli Angelo investigator.; Reed Ann investigator.; Rennebohm Robert investigator.; Sherry David D. investigator.; Silva Clovis A. investigator.; Stringer Elizabeth investigator.; van Royen‐Kerkhof Annet investigator.; Wallace Carol investigator.; Miller Frederick W. investigator.; Oddis Chester V. investigator.; Reed Ann investigator.; Rider Lisa G. investigator.; Ruperto Nicolino investigator.; Apaz Maria investigator.; Avcin Tadej investigator.; Becker Mara investigator.; Beresford Michael W. investigator.; Cimaz Rolando investigator.; Constantin Tamás investigator.; Curran Megan investigator.; Cuttica Ruben investigator.; Davidson Joyce investigator.; Dressler Frank investigator.; Dvergsten Jeffrey investigator.; Feitosa de Oliveira Sheila Knupp investigator.; Feldman Brian M. investigator.; Leme Ferriani Virginia Paes investigator.; Flato Berit investigator.; Gerloni Valeria investigator.; Griffin Thomas investigator.; Henrickson Michael investigator.; Hinze Claas investigator.; Hoeltzel Mark investigator.; Huber Adam M. investigator.; Ibarra Maria investigator.; Ilowite Norman investigator.; Imundo Lisa investigator.; Jones Olcay investigator.; Kim Susan investigator.; Kingsbury Daniel investigator.; Lang Bianca investigator.; Lindsley Carol investigator.; Lovell Daniel investigator.; Martini Alberto investigator.; Saad Magalhaes Claudia investigator.; Magnusson Bo investigator.; Maguiness Sheilagh investigator.; Maillard Susan investigator.; Mathiesen Pernille investigator.; McCann Liza investigator.; Nielsen Susan investigator.; Pachman Lauren M. investigator.; Passo Murray investigator.; Pilkington Clarissa investigator.; Punaro Marilynn investigator.; Quartier Pierre investigator.; Rabinovich Egla investigator.; Ramanan Athimalaipet V. investigator.; Ravelli Angelo investigator.; Reed Ann investigator.; Rennebohm Robert investigator.; Rider Lisa G. investigator.; Rivas‐Chacon Rafael investigator.; Byun Robinson Angela investigator.; Rouster‐Stevens Kelly investigator.; Russo Ricardo investigator.; Rutkowska‐Sak Lidia investigator.; Sallum Adriana investigator.; Sanner Helga investigator.; Schmeling Heinrike investigator.; Selcen Duygu investigator.; Shaham Bracha investigator.; Sherry David D. investigator.; Silva Clovis A. investigator.; Spencer Charles H. investigator.; Sundel Robert investigator.; Tardieu Marc investigator.; Thatayatikom Akaluck investigator.; van der Net Janjaap investigator.; van Royen‐Kerkhof Annet investigator.; Wahezi Dawn investigator.; Wallace Carol investigator.; Zulian Francesco investigator.; analysis Conjoint investigator.; Cimaz Rolando investigator.; Constantin Tamás investigator.; Cuttica Ruben investigator.; Davidson Joyce investigator.; Dressler Frank investigator.; Knupp Feitosa de Oliveira Sheila investigator.; Feldman Brian M. investigator.; Griffin Thomas investigator.; Henrickson Michael investigator.; Huber Adam M. investigator.; Imundo Lisa investigator.; Lang Bianca investigator.; Lindsley Carol investigator.; Saad Magalhaes Claudia investigator.; Magnusson Bo investigator.; Maillard Susan investigator.; Pachman Lauren M. investigator.; Passo Murray investigator.; Pilkington Clarissa investigator.; Punaro Marilynn investigator.; Ravelli Angelo investigator.; Reed Ann investigator.; Rider Lisa G. investigator.; Rouster‐Stevens Kelly investigator.; Russo Ricardo investigator.; Shaham Bracha investigator.; Sundel Robert investigator.; van der Net Janjaap investigator.; van Royen‐Kerkhof Annet investigator.; Cimaz Rolando investigator.; Cuttica Rubén investigator.; Knupp Feitosa de Oliveira Sheila investigator.; Feldman Brian M. investigator.; Huber Adam M. investigator.; Lindsley Carol B. investigator.; Pilkington Clarissa investigator.; Punaro Marilynn investigator.; Ravelli Angelo investigator.; Reed Ann investigator.; Rouster‐Stevens Kelly investigator.; van Royen‐Kerkhof Annet investigator.; Amato Anthony investigator.; Chinoy Hector investigator.; Cooper Robert G. investigator.; Dastmalchi Maryam investigator.; de Visser Marianne investigator.; Fiorentino David investigator.; Isenberg David investigator.; Katz James investigator.; Mammen Andrew investigator.; Oddis Chester V. investigator.; Vencovsky Jiri investigator.; Ytterberg Steven R. investigator.;
• Is Part Of: Arthritis & rheumatology. Volume 69:Issue 5(2017)
• Page Start: 911
• Page End: 923
• Publication Date: 2017-04-06
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.40060
• Languages: English
• ISSNs: 2326-5191

Abstract

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.