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

Arthritis and Rheumatology

Volumn 69, Issue 5, 2017, Pages 898-910

  Aggarwal, Rohit ^a,s   Rider, Lisa G ^b,s   Ruperto, Nicolino ^c,s   Bayat, Nastaran ^b,s   Erman, Brian ^d,s   Feldman, Brian M ^e,s   Oddis, Chester V ^a,s   Amato, Anthony A ^f,s   Chinoy, Hector ^g,s   Cooper, Robert G ^h,s   Dastmalchi, Maryam ^i,s   Fiorentino, David ^j,s   Isenberg, David ^k,s   Katz, James D ^b,s   Mammen, Andrew ^l,s   de Visser, Marianne ^m,s   Ytterberg, Steven R ^n,s   Lundberg, Ingrid E ⁱ   Chung, Lorinda ^j,s   Danko, Katalin ^o   García De la Torre, Ignacio ^p,s   Song, Yeong Wook ^q   Villa, Luca ^c   Rinaldi, Mariangela ^c   Rockette, Howard ^a,s   Lachenbruch, Peter A ^b,s   Miller, Frederick W ^b,s   Vencovsky, Jiri ^r,s   Pistorio, Angela ^s   Huber, Adam M ^s   Hansen, Paul ^s   Christopher Stine, Lisa ^s   Criscione Schreiber, Lisa ^s   Crofford, Leslie ^s   Cronin, Mary E ^s   Dankó, Katalin ^s   Gordon, Patrick ^s   Hengstman, Gerald ^s   Marder, Galina ^s   McHugh, Neil ^s   Schiopu, Elena ^s   Selva O'Callaghan, Albert ^s   Wook Song, Yeong ^s   Wolfe, Gil ^s   Wortmann, Robert ^s   Gourley, Mark ^s   Lundberg, Ingrid ^s   Plotz, Paul ^s   Ascherman, Dana ^s   Barohn, Richard ^s   Benveniste, Olivier ^s   De Bleecker, Jan ^s   Callen, Jeffrey ^s   Charles Schoeman, Christina ^s   Danoff, Sonye ^s   Dimachkie, Mazen ^s   DiMartino, Steve ^s   Dourmishev, Lyubomir ^s   Ernste, Floranne ^s   Gono, Takahisa ^s   Katsumata, Yasuhiro ^s   Kissel, John ^s   Leff, Richard L ^s   Levine, Todd ^s   Mann, Herman ^s   Marie, Isabelle ^s   Merola, Joseph ^s   Olesinska, Marzena ^s   Olsen, Nancy ^s   Pipitone, Nicolo ^s   Ramchandren, Sindhu ^s   Rutkove, Seward ^s   Saketkoo, Lesley Ann ^s   Schiffenbauer, Adam ^s   Katsuyuki Shinjo, Samuel ^s   Shupak, Rachel ^s   Swierkocka, Katarzyna ^s   Wanschitz, Julia ^s   Werth, Victoria ^s   Whitt, Irene ^s   Cimaz, Rolando ^s   Cuttica, Rubén ^s   Feitosa de Oliveira, Sheila Knupp ^s   Lindsley, Carol B ^s   Pilkington, Clarissa ^s   Punaro, Marilynn ^s   Ravelli, Angelo ^s   Reed, Ann ^s   Rouster Stevens, Kelly ^s   van Royen Kerkhof, Annet ^s   more..

^a UNIVERSITY OF PITTSBURGH   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c G GASLINI INSTITUTE   (Italy)

^d SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^e HOSPITAL FOR SICK CHILDREN   (Canada)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^h UNIVERSITY OF LIVERPOOL   (United Kingdom)

ⁱ KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^j STANFORD UNIVERSITY   (United States)

^k UNIVERSITY COLLEGE LONDON   (United Kingdom)

^l JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m ACADEMIC MEDICAL CENTER   (Netherlands)

ⁿ MAYO CLINIC   (United States)

^o UNIVERSITY OF DEBRECEN   (Hungary)

^p HOSPITAL GENERAL DE OCCIDENTE   (Mexico)

^q Seoul National University   (South Korea)

^r CHARLES UNIVERSITY   (Czech Republic)

^s NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

MUSCLE ENZYME; ALANINE AMINOTRANSFERASE; ANTIRHEUMATIC AGENT; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; FRUCTOSE BISPHOSPHATE ALDOLASE; LACTATE DEHYDROGENASE;

ADULT; ARTICLE; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; CRITERION VARIABLE; DERMATOMYOSITIS; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; MAJOR CLINICAL STUDY; MALE; MUSCLE STRENGTH; PHYSICIAN; POLYMYOSITIS; PRIORITY JOURNAL; RHEUMATIC DISEASE; SENSITIVITY AND SPECIFICITY; TREATMENT RESPONSE; WEIGHT; EUROPE; MEDICAL SOCIETY; METABOLISM; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PATIENT-REPORTED OUTCOME; QUESTIONNAIRE; RHEUMATOLOGY; STATISTICAL MODEL; TREATMENT OUTCOME; UNITED STATES;

ALANINE TRANSAMINASE; ANTIRHEUMATIC AGENTS; ASPARTATE AMINOTRANSFERASES; CREATINE KINASE; DERMATOMYOSITIS; EUROPE; FRUCTOSE-BISPHOSPHATE ALDOLASE; HUMANS; L-LACTATE DEHYDROGENASE; LOGISTIC MODELS; MUSCLE STRENGTH; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT REPORTED OUTCOME MEASURES; POLYMYOSITIS; RHEUMATOLOGY; SOCIETIES, MEDICAL; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; UNITED STATES;

EID: 85017448052     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.40064     Document Type: Article

References (46)

1. Rider LG, Miller FW. Deciphering the clinical presentations, pathogenesis, and treatment of the idiopathic inflammatory myopathies. JAMA 2011;305:183–90.
2. Moghadam-Kia S, Aggarwal R, Oddis CV. Treatment of inflammatory myopathy: emerging therapies and therapeutic targets. Expert Rev Clin Immunol 2015;11:1265–75.
3. Oddis CV, Reed AM, Aggarwal R, Rider LG, Ascherman DP, Levesque MC, et al. Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo-phase trial. Arthritis Rheum 2013;65:314–24.
4. Muscle Study Group. A randomized, pilot trial of etanercept in dermatomyositis. Ann Neurol 2011;70:427–36.
5. Ruperto N, Pistorio A, Oliveira S, Zulian F, Cuttica R, Ravelli A, et al. Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial. Lancet 2016;387:671–8.
6. Rider LG, Werth VP, Huber AM, Alexanderson H, Rao AP, Ruperto N, et al. Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: Physician and Patient/Parent Global Activity, Manual Muscle Testing (MMT), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (C-HAQ), Childhood Myositis Assessment Scale (CMAS), Myositis Disease Activity Assessment Tool (MDAAT), Disease Activity Score (DAS), Short Form 36 (SF-36), Child Health Questionnaire (CHQ), Physician Global Damage, Myositis Damage Index (MDI), Quantitative Muscle Testing (QMT), Myositis Functional Index-2 (FI-2), Myositis Activities Profile (MAP), Inclusion Body Myositis Functional Rating Scale (IBMFRS), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Cutaneous Assessment Tool (CAT), Dermatomyositis Skin Severity Index (DSSI), Skindex, and Dermatology Life Quality Index (DLQI). Arthritis Care Res (Hoboken) 2011;63 Suppl 11:S118–57.
7. Miller FW, Rider LG, Chung YL, Cooper R, Danko K, Farewell V, et al. Proposed preliminary core set measures for disease outcome assessment in adult and juvenile idiopathic inflammatory myopathies. Rheumatology (Oxford) 2001;40:1262–73.
8. Rider LG, Giannini EH, Harris-Love M, Joe G, Isenberg D, Pilkington C, et al. Defining clinical improvement in adult and juvenile myositis. J Rheumatol 2003;30:603–17.
9. Rider LG, Giannini EH, Brunner HI, Ruperto N, James-Newton L, Reed AM, et al. International consensus on preliminary definitions of improvement in adult and juvenile myositis. Arthritis Rheum 2004;50:2281–90.
10. American College of Rheumatology Committee to Reevaluate Improvement Criteria. A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. Arthritis Rheum 2007;57:193–202.
11. De Lautour H, Taylor WJ, Adebajo A, Alten R, Burgos-Vargas R, Chapman P, et al. Development of preliminary remission criteria for gout using Delphi and 1000Minds consensus exercises. Arthritis Care Res (Hoboken) 2016;68:667–72.
12. Johnson SR, Naden RP, Fransen J, van Den Hoogen F, Pope JE, Baron M, et al. Multicriteria decision analysis methods with 1000Minds for developing systemic sclerosis classification criteria. J Clin Epidemiol 2014;67:706–14.
13. Hansen P, Ombler F. A new method for scoring additive multi-attribute value models using pairwise rankings of alternatives. J Multi-Crit Decis Anal 2008;15:87–107.
14. Amaya-Amaya M, Gerard K, Ryan M. Discrete choice experiments in a nutshell. In: Ryan M, Gerard K, Amaya-Amaya M, editors. Using discrete choice experiments to value health and health care. Dordrecht: Springer; 2008.
15. Ruperto N, Martini A. Networking in paediatrics: the example of the Paediatric Rheumatology International Trials Organisation (PRINTO). Arch Dis Child 2011;96:596–601.
16. Taylor WJ, Singh JA, Saag KG, Dalbeth N, MacDonald PA, Edwards NL, et al. Bringing it all together: a novel approach to the development of response criteria for chronic gout clinical trials. J Rheumatol 2011;38:1467–70.
17. Taylor WJ, Brown M, Aati O, Weatherall M, Dalbeth N. Do patient preferences for core outcome domains for chronic gout studies support the validity of composite response criteria? Arthritis Care Res (Hoboken) 2013;65:1259–64.
18. Utz KS, Hoog J, Wentrup A, Berg S, Lammer A, Jainsch B, et al. Patient preferences for disease-modifying drugs in multiple sclerosis therapy: a choice-based conjoint analysis. Ther Adv Neurol Disord 2014;7:263–75.
19. De Bekker-Grob E, Ryan M, Gerard K. Discrete choice experiments in health economics: a review of the literature. Health Econ 2012;21:145–72.
20. Rider LG, Aggarwal R, Pistorio A, Bayat N, Erman B, Feldman BM, et al. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate and major clinical response for juvenile dermatomyositis: an International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation collaborative initiative. Arthritis Rheumatol 2017;69:911–23.
21. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137–45.
22. Rider LG. Outcome assessment in the adult and juvenile idiopathic inflammatory myopathies. Rheum Dis Clin North Am 2002;28:935–77.
23. Aggarwal R, Rider LG, Ruperto N, Bayat N, Erman B, Feldman BM, et al. A consensus hybrid definition using a conjoint analysis is the proposed response criteria for minimal and moderate improvement for adult polymyositis and dermatomyositis clinical trials [abstract]. Arthritis Rheumatol 2014;66 Suppl:S404.
24. Rider LG, Ruperto N, Pistorio A, Erman B, Bayat N, Lachenbruch PA, et al. 2016 development of adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria: methodological aspects: an American College of Rheumatology/European League Against Rheumatism/International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation collaborative initiative. Rheumatology (Oxford). In press.
25. Bohan A, Peter JB. Polymyositis and dermatomyositis. Parts 1 and 2. N Engl J Med 1975;292:344–7, 403–7.
26. Rider LG, Lee J, Jansen A, Ruperto N, Huber AM, Oddis CV, et al. Defining clinically relevant changes in core set activity measures for adult and juvenile idiopathic inflammatory myopathies (IIM) [abstract]. Arthritis Rheum 2011;63 (Suppl):S89.
27. Metz CE. Basic principles of ROC analysis. Semin Nucl Med 1978;8:283–98.
28. Ruperto N, Meiorin S, Iusan SM, Ravelli A, Pistorio A, Martini A. Consensus procedures and their role in pediatric rheumatology. Curr Rheumatol Rep 2008;10:142–6.
29. Delbecq A, van de Ven A, Gustafson D. Group techniques for program planning: a guide to nominal group and Delphi processes. Glenview (IL): Scott, Foresman and Company; 1975.
30. Nair R, Aggarwal R, Khanna D. Methods of formal consensus in classification/diagnostic criteria and guideline development. Semin Arthritis Rheum 2011;41:95–105.
31. Ruperto N, Ozen S, Pistorio A, Dolezalova P, Brogan P, Cabral DA, et al. EULAR/PRINTO/PRES criteria for Henoch-Schonlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part I: overall methodology and clinical characterisation. Ann Rheum Dis 2010;69:790–7.
32. Piram M, Kone-Paut I, Lachmann HJ, Frenkel J, Ozen S, Kuemmerle-Deschner J, et al. Validation of the auto-inflammatory diseases activity index (AIDAI) for hereditary recurrent fever syndromes. Ann Rheum Dis 2014;73:2168–73.
33. Ware JE Jr, Snow KK, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
34. Ruperto N, Ravelli A, Pistorio A, Ferriani V, Calvo I, Ganser G, et al. The provisional Paediatric Rheumatology International Trials Organisation/American College of Rheumatology/European League Against Rheumatism Disease Activity Core Set for the Evaluation of Response to Therapy in Juvenile Dermatomyositis: a prospective validation study. Arthritis Rheum 2008;59:4–13.
35. Ruperto N, Ravelli A, Pistorio A, Malattia C, Cavuto S, Gado-West L, et al. Cross-cultural adaptation and psychometric evaluation of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ) in 32 countries: review of the general methodology. Clin Exp Rheumatol 2001;19 Suppl 23:S1–9.
36. Apaz MT, Saad-Magalhaes C, Pistorio A, Ravelli A, de Oliveira Sato J, Marcantoni MB, et al. Health-related quality of life of patients with juvenile dermatomyositis: results from the Paediatric Rheumatology International Trials Organisation Multinational Quality of Life cohort study. Arthritis Rheum 2009;61:509–17.
37. Van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2013;65:2737–47.
38. Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, et al. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: phase 2 methodological report. Arthritis Rheum 2010;62:2582–91.
39. Neogi T, Jansen TL, Dalbeth N, Fransen J, Schumacher HR, Berendsen D, et al. 2015 gout classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheumatol 2015;67:2557–68.
40. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727–35.
41. Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum 2011;63:573–86.
42. Aggarwal R, Cassidy E, Fertig N, Koontz DC, Lucas M, Ascherman DP, et al. Patients with non-Jo-1 anti-tRNA-synthetase autoantibodies have worse survival than Jo-1 positive patients. Ann Rheum Dis 2014;73:227–32.
43. Hengstman GJ, ter Laak HJ, Vree Egberts WT, Lundberg IE, Moutsopoulos HM, Vencovsky J, et al. Anti-signal recognition particle autoantibodies: marker of a necrotising myopathy. Ann Rheum Dis 2006;65:1635–8.
44. Tjarnlund A, Bottai M, Rider LG, Werth VP, Pilkington CA, de Visser M, et al. Progress report on development of classification criteria for adult and juvenile idiopathic inflammatory myopathies [abstract]. Arthritis Rheum 2012;64 Suppl:S323–4.
45. Alexanderson H, del Grande M, Bingham CO III, Orbai AM, Sarver C, Clegg-Smith K, et al. Patient-reported outcomes and adult patients' disease experience in the idiopathic inflammatory myopathies: report from the OMERACT 11 Myositis Special Interest Group. J Rheumatol 2014;41:581–92.
46. Volochayev R, Csako G, Wesley R, Rider LG, Miller FW. Laboratory test abnormalities are common in polymyositis and dermatomyositis and differ among clinical and demographic groups. Open Rheumatol J 2012;6:54–63.