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Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles
Abstract 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-reporte...
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| Published in: | Rheumatology (Oxford, England) England), 2023-11, Vol.62 (11), p.3680-3689 |
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| creator | Kim, Hanna Saygin, Didem Douglas, Christian Wilkerson, Jesse Erman, Brian Pistorio, Angela McGrath, John A Reed, Ann M Oddis, Chester V Bracaglia, Claudia van Royen-Kerkhof, Annet Bica, Blanca Dolezalova, Pavla Ferriani, Virginia P L Flato, Berit Bernard-Medina, Ana G Herlin, Troels Miller, Frederick W Vencovsky, Jiri Ruperto, Nicolino Aggarwal, Rohit Rider, Lisa G |
| description | Abstract
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. |
| doi_str_mv | 10.1093/rheumatology/kead111 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10629769</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/rheumatology/kead111</oup_id><sourcerecordid>2854430384</sourcerecordid><originalsourceid>FETCH-LOGICAL-c398t-8decf9e7c3d30c0e5a30c399cc920b3fa6f2d38b3d1108157272f31480bd0e083</originalsourceid><addsrcrecordid>eNqNkU1rGzEQhkVpaD7af1CCjr1srI_1WjoFY9ImYEgIyVnI2lGsdFfaSNqAr_3llbFjkltOI5hnHg3zIvSTkgtKJJ_ENYy9zqELT5vJX9AtpfQLOqF1wyrCOft6eLP6GJ2m9EwImVIuvqFj3kgmJRUn6N8dRBtir70BHCzOa8CM0AbPF_fV1eNyfo_7TUguu4QjpCH4BNhElyE6jZ3Hz-MreNcBbiFu1znQxRT1AGN2BucCdwlr32KzNfg0JjzEYMtg-o6ObOnCj309Q4-_rx4W19Xy9s_NYr6sDJciV6IFYyXMDG85MQSmuhQupTGSkRW3urGs5WLFyyGIoNMZmzHLaS3IqiVABD9DlzvvMK56aA34HHWnhuh6HTcqaKc-drxbq6fwqihpmJw1shh-7Q0xvIyQsupdMtB12kMYk2JiWteccFEXtN6hJoaUItjDP5SobX7qfX5qn18ZO3-_42HoLbACTHZAGIfPKf8DfxCwQQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2854430384</pqid></control><display><type>article</type><title>Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles</title><source>Oxford Journals Online</source><creator>Kim, Hanna ; Saygin, Didem ; Douglas, Christian ; Wilkerson, Jesse ; Erman, Brian ; Pistorio, Angela ; McGrath, John A ; Reed, Ann M ; Oddis, Chester V ; Bracaglia, Claudia ; van Royen-Kerkhof, Annet ; Bica, Blanca ; Dolezalova, Pavla ; Ferriani, Virginia P L ; Flato, Berit ; Bernard-Medina, Ana G ; Herlin, Troels ; Miller, Frederick W ; Vencovsky, Jiri ; Ruperto, Nicolino ; Aggarwal, Rohit ; Rider, Lisa G</creator><creatorcontrib>Kim, Hanna ; Saygin, Didem ; Douglas, Christian ; Wilkerson, Jesse ; Erman, Brian ; Pistorio, Angela ; McGrath, John A ; Reed, Ann M ; Oddis, Chester V ; Bracaglia, Claudia ; van Royen-Kerkhof, Annet ; Bica, Blanca ; Dolezalova, Pavla ; Ferriani, Virginia P L ; Flato, Berit ; Bernard-Medina, Ana G ; Herlin, Troels ; Miller, Frederick W ; Vencovsky, Jiri ; Ruperto, Nicolino ; Aggarwal, Rohit ; Rider, Lisa G ; International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO) ; for the International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</creatorcontrib><description>Abstract
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.</description><identifier>ISSN: 1462-0324</identifier><identifier>EISSN: 1462-0332</identifier><identifier>DOI: 10.1093/rheumatology/kead111</identifier><identifier>PMID: 36929918</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Clinical Science ; Consensus ; Dermatomyositis - drug therapy ; Humans ; Muscle Strength ; Myositis - drug therapy ; Rituximab - therapeutic use</subject><ispartof>Rheumatology (Oxford, England), 2023-11, Vol.62 (11), p.3680-3689</ispartof><rights>Published by Oxford University Press on behalf of the British Society for Rheumatology 2023. 2023</rights><rights>Published by Oxford University Press on behalf of the British Society for Rheumatology 2023.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c398t-8decf9e7c3d30c0e5a30c399cc920b3fa6f2d38b3d1108157272f31480bd0e083</cites><orcidid>0000-0001-8407-7782 ; 0000-0002-6912-2458 ; 0000-0002-0595-6533</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,786,790,891,1591,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36929918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Hanna</creatorcontrib><creatorcontrib>Saygin, Didem</creatorcontrib><creatorcontrib>Douglas, Christian</creatorcontrib><creatorcontrib>Wilkerson, Jesse</creatorcontrib><creatorcontrib>Erman, Brian</creatorcontrib><creatorcontrib>Pistorio, Angela</creatorcontrib><creatorcontrib>McGrath, John A</creatorcontrib><creatorcontrib>Reed, Ann M</creatorcontrib><creatorcontrib>Oddis, Chester V</creatorcontrib><creatorcontrib>Bracaglia, Claudia</creatorcontrib><creatorcontrib>van Royen-Kerkhof, Annet</creatorcontrib><creatorcontrib>Bica, Blanca</creatorcontrib><creatorcontrib>Dolezalova, Pavla</creatorcontrib><creatorcontrib>Ferriani, Virginia P L</creatorcontrib><creatorcontrib>Flato, Berit</creatorcontrib><creatorcontrib>Bernard-Medina, Ana G</creatorcontrib><creatorcontrib>Herlin, Troels</creatorcontrib><creatorcontrib>Miller, Frederick W</creatorcontrib><creatorcontrib>Vencovsky, Jiri</creatorcontrib><creatorcontrib>Ruperto, Nicolino</creatorcontrib><creatorcontrib>Aggarwal, Rohit</creatorcontrib><creatorcontrib>Rider, Lisa G</creatorcontrib><creatorcontrib>International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</creatorcontrib><creatorcontrib>for the International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</creatorcontrib><title>Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles</title><title>Rheumatology (Oxford, England)</title><addtitle>Rheumatology (Oxford)</addtitle><description>Abstract
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.</description><subject>Clinical Science</subject><subject>Consensus</subject><subject>Dermatomyositis - drug therapy</subject><subject>Humans</subject><subject>Muscle Strength</subject><subject>Myositis - drug therapy</subject><subject>Rituximab - therapeutic use</subject><issn>1462-0324</issn><issn>1462-0332</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqNkU1rGzEQhkVpaD7af1CCjr1srI_1WjoFY9ImYEgIyVnI2lGsdFfaSNqAr_3llbFjkltOI5hnHg3zIvSTkgtKJJ_ENYy9zqELT5vJX9AtpfQLOqF1wyrCOft6eLP6GJ2m9EwImVIuvqFj3kgmJRUn6N8dRBtir70BHCzOa8CM0AbPF_fV1eNyfo_7TUguu4QjpCH4BNhElyE6jZ3Hz-MreNcBbiFu1znQxRT1AGN2BucCdwlr32KzNfg0JjzEYMtg-o6ObOnCj309Q4-_rx4W19Xy9s_NYr6sDJciV6IFYyXMDG85MQSmuhQupTGSkRW3urGs5WLFyyGIoNMZmzHLaS3IqiVABD9DlzvvMK56aA34HHWnhuh6HTcqaKc-drxbq6fwqihpmJw1shh-7Q0xvIyQsupdMtB12kMYk2JiWteccFEXtN6hJoaUItjDP5SobX7qfX5qn18ZO3-_42HoLbACTHZAGIfPKf8DfxCwQQ</recordid><startdate>20231102</startdate><enddate>20231102</enddate><creator>Kim, Hanna</creator><creator>Saygin, Didem</creator><creator>Douglas, Christian</creator><creator>Wilkerson, Jesse</creator><creator>Erman, Brian</creator><creator>Pistorio, Angela</creator><creator>McGrath, John A</creator><creator>Reed, Ann M</creator><creator>Oddis, Chester V</creator><creator>Bracaglia, Claudia</creator><creator>van Royen-Kerkhof, Annet</creator><creator>Bica, Blanca</creator><creator>Dolezalova, Pavla</creator><creator>Ferriani, Virginia P L</creator><creator>Flato, Berit</creator><creator>Bernard-Medina, Ana G</creator><creator>Herlin, Troels</creator><creator>Miller, Frederick W</creator><creator>Vencovsky, Jiri</creator><creator>Ruperto, Nicolino</creator><creator>Aggarwal, Rohit</creator><creator>Rider, Lisa G</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8407-7782</orcidid><orcidid>https://orcid.org/0000-0002-6912-2458</orcidid><orcidid>https://orcid.org/0000-0002-0595-6533</orcidid></search><sort><creationdate>20231102</creationdate><title>Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles</title><author>Kim, Hanna ; Saygin, Didem ; Douglas, Christian ; Wilkerson, Jesse ; Erman, Brian ; Pistorio, Angela ; McGrath, John A ; Reed, Ann M ; Oddis, Chester V ; Bracaglia, Claudia ; van Royen-Kerkhof, Annet ; Bica, Blanca ; Dolezalova, Pavla ; Ferriani, Virginia P L ; Flato, Berit ; Bernard-Medina, Ana G ; Herlin, Troels ; Miller, Frederick W ; Vencovsky, Jiri ; Ruperto, Nicolino ; Aggarwal, Rohit ; Rider, Lisa G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c398t-8decf9e7c3d30c0e5a30c399cc920b3fa6f2d38b3d1108157272f31480bd0e083</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Clinical Science</topic><topic>Consensus</topic><topic>Dermatomyositis - drug therapy</topic><topic>Humans</topic><topic>Muscle Strength</topic><topic>Myositis - drug therapy</topic><topic>Rituximab - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Hanna</creatorcontrib><creatorcontrib>Saygin, Didem</creatorcontrib><creatorcontrib>Douglas, Christian</creatorcontrib><creatorcontrib>Wilkerson, Jesse</creatorcontrib><creatorcontrib>Erman, Brian</creatorcontrib><creatorcontrib>Pistorio, Angela</creatorcontrib><creatorcontrib>McGrath, John A</creatorcontrib><creatorcontrib>Reed, Ann M</creatorcontrib><creatorcontrib>Oddis, Chester V</creatorcontrib><creatorcontrib>Bracaglia, Claudia</creatorcontrib><creatorcontrib>van Royen-Kerkhof, Annet</creatorcontrib><creatorcontrib>Bica, Blanca</creatorcontrib><creatorcontrib>Dolezalova, Pavla</creatorcontrib><creatorcontrib>Ferriani, Virginia P L</creatorcontrib><creatorcontrib>Flato, Berit</creatorcontrib><creatorcontrib>Bernard-Medina, Ana G</creatorcontrib><creatorcontrib>Herlin, Troels</creatorcontrib><creatorcontrib>Miller, Frederick W</creatorcontrib><creatorcontrib>Vencovsky, Jiri</creatorcontrib><creatorcontrib>Ruperto, Nicolino</creatorcontrib><creatorcontrib>Aggarwal, Rohit</creatorcontrib><creatorcontrib>Rider, Lisa G</creatorcontrib><creatorcontrib>International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</creatorcontrib><creatorcontrib>for the International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Rheumatology (Oxford, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Hanna</au><au>Saygin, Didem</au><au>Douglas, Christian</au><au>Wilkerson, Jesse</au><au>Erman, Brian</au><au>Pistorio, Angela</au><au>McGrath, John A</au><au>Reed, Ann M</au><au>Oddis, Chester V</au><au>Bracaglia, Claudia</au><au>van Royen-Kerkhof, Annet</au><au>Bica, Blanca</au><au>Dolezalova, Pavla</au><au>Ferriani, Virginia P L</au><au>Flato, Berit</au><au>Bernard-Medina, Ana G</au><au>Herlin, Troels</au><au>Miller, Frederick W</au><au>Vencovsky, Jiri</au><au>Ruperto, Nicolino</au><au>Aggarwal, Rohit</au><au>Rider, Lisa G</au><aucorp>International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</aucorp><aucorp>for the International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles</atitle><jtitle>Rheumatology (Oxford, England)</jtitle><addtitle>Rheumatology (Oxford)</addtitle><date>2023-11-02</date><risdate>2023</risdate><volume>62</volume><issue>11</issue><spage>3680</spage><epage>3689</epage><pages>3680-3689</pages><issn>1462-0324</issn><eissn>1462-0332</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>H.K. and D.S. are co-first authors.</notes><notes>See acknowledgements section for a list of the International Myositis Assessment and Clinical Studies Group (IMACS) and Paediatric Rheumatology INternational Trials Organization (PRINTO) contributions to this study.</notes><abstract>Abstract
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.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>36929918</pmid><doi>10.1093/rheumatology/kead111</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8407-7782</orcidid><orcidid>https://orcid.org/0000-0002-6912-2458</orcidid><orcidid>https://orcid.org/0000-0002-0595-6533</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1462-0324 |
| ispartof | Rheumatology (Oxford, England), 2023-11, Vol.62 (11), p.3680-3689 |
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| language | eng |
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| source | Oxford Journals Online |
| subjects | Clinical Science Consensus Dermatomyositis - drug therapy Humans Muscle Strength Myositis - drug therapy Rituximab - therapeutic use |
| title | Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles |
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