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Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles
H. Kim, D. Saygin, C. Douglas, J. Wilkerson, B. Erman, A. Pistorio, JA. McGrath, AM. Reed, CV. Oddis, C. Bracaglia, A. van Royen-Kerkhof, B. Bica, P. Dolezalova, VPL. Ferriani, B. Flato, AG. Bernard-Medina, T. Herlin, FW. Miller, J. Vencovsky, N....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem, Research Support, N.I.H., Intramural
Grantová podpora
HHSN273201600002C
NIEHS NIH HHS - United States
ZIA AR041215
Intramural NIH HHS - United States
HHSN273201600002I
NIEHS NIH HHS - United States
ZIA ES101081
Intramural NIH HHS - United States
NLK
Free Medical Journals
od 1996 do Před 1 rokem
Open Access Digital Library
od 1996-01-01
Medline Complete (EBSCOhost)
od 1999-01-01 do Před 1 rokem
- MeSH
- dermatomyozitida * farmakoterapie MeSH
- konsensus MeSH
- lidé MeSH
- myozitida * farmakoterapie MeSH
- rituximab terapeutické užití MeSH
- svalová síla MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Research Support, N.I.H., Intramural MeSH
OBJECTIVES: The 2016 ACR-EULAR Response Criteria for JDM was developed as a composite measure with differential weights of six core set measures (CSMs) to calculate a Total Improvement Score (TIS). We assessed the contribution of each CSM, representation of muscle-related and patient-reported CSMs towards improvement, and frequency of CSM worsening across myositis response criteria (MRC) categories in validation of MRC. METHODS: Data from JDM patients in the Rituximab in Myositis trial (n = 48), PRINTO JDM trial (n = 139), and consensus patient profiles (n = 273) were included. Observed vs expected CSM contributions were compared using Sign test. Characteristics of MRC categories were compared by Wilcoxon tests with Bonferroni adjustment. Spearman correlation of changes in TIS and individual CSMs were examined. Agreement between physician-assessed change and MRC categories was evaluated by weighted Cohen's kappa. RESULTS: Of 457 JDM patients with IMACS CSMs and 380 with PRINTO CSMs, 9-13% had minimal, 19-23% had moderate and 41-50% had major improvement. The number of improved and absolute percentage change of CSMs increased by MRC improvement level. Patients with minimal improvement by MRC had a median of 0-1 CSM worsened, and those with moderate/major improvement had a median of zero worsening CSMs. Of patients improved by MRC, 94-95% had improvement in muscle strength and 93-95% had improvement in ≥1 patient-reported CSM. IMACS and PRINTO CSMs performed similarly. Physician-rated change and MRC improvement categories had moderate-to-substantial agreement (Kappa 0.5-0.7). CONCLUSION: The ACR-EULAR MRC perform consistently across multiple studies, supporting its further use as an efficacy end point in JDM trials.
Department of Pediatrics Duke University Durham NC USA
Division of Rheumatology IRCCS Ospedale Pediatrico Bambino Gesù Roma Italy
Division of Rheumatology Ribeirao Preto Medical School Sao Paulo University Ribeirao Preto Brazil
General University Hospital and 1st Faculty of Medicine Charles University Prague Czech Republic
Hospital Civil de Guadalajara FrayAntonio Alcalde Guadalajara Mexico
Institute of Rheumatology Department of Rheumatology Charles University Prague Czech Republic
IRCCS Istituto Giannina Gaslini Direzione Scientifica Genoa Italy
Pediatrics and Adolescent Medicine Aarhus University Hospital Aarhus Denmark
Section of Rheumatology Department of Medicine University of Chicago Chicago IL USA
Social and Scientific Systems Inc Durham NC USA
UOSID Centro Trial PRINTO IRCCS Istituto Giannina Gaslini Genova Italy
Citace poskytuje Crossref.org
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