{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:28:31Z","timestamp":1791941311852,"version":"4.3.4"},"reference-count":38,"publisher":"SAGE Publications","issue":"14","license":[{"start":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T00:00:00Z","timestamp":1663718400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Overall Disability Response Score (ODRS) is a composite endpoint including Expanded Disability Status Scale, Timed 25-foot Walk, and 9-Hole Peg Test, designed to quantify both disability improvement and worsening in multiple sclerosis (MS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To assess the sensitivity and clinical meaningfulness of ODRS using natalizumab Phase 3 data sets (AFFIRM in relapsing-remitting MS and ASCEND in secondary progressive MS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Differences in ODRS over 96\u2009weeks, ODRS at Week 96, and slope of ODRS change per year between natalizumab and placebo groups were analyzed. Correlation between ODRS and changes in patient-reported outcomes was also analyzed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The difference (95% confidence interval (CI)) in the ODRS over 96\u2009weeks between natalizumab and placebo groups was 0.34 (0.21\u20130.46) in AFFIRM ( p\u2009&lt;\u20090.001), and 0.18 (0.03\u20130.34) in ASCEND ( p\u2009=\u20090.021). Significant differences between treatment arms were also observed in ODRS at Week 96 and in the slope of change per year in both studies. There was a significant linear correlation between ODRS at Week 96 and the change from baseline in both the physical and mental components of the 36-item Short Form Survey (SF-36) in both studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This analysis supports ODRS as a sensitive and potentially clinically meaningful disability outcome measure in MS.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585221114997","type":"journal-article","created":{"date-parts":[[2022,9,22]],"date-time":"2022-09-22T02:14:37Z","timestamp":1663812877000},"page":"2263-2273","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis"],"prefix":"10.1177","volume":"28","author":[{"given":"Ih","family":"Chang","sequence":"first","affiliation":[{"name":"Cerevel Therapeutics, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4175-5509","authenticated-orcid":false,"given":"Ludwig","family":"Kappos","sequence":"additional","affiliation":[{"name":"Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head, Spine and Neuromedicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Giovannoni","sequence":"additional","affiliation":[{"name":"Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7776-6472","authenticated-orcid":false,"given":"Peter A","family":"Calabresi","sequence":"additional","affiliation":[{"name":"The Johns Hopkins Multiple Sclerosis Center, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfred","family":"Sandrock","sequence":"additional","affiliation":[{"name":"Voyager Therapeutics, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenting","family":"Cheng","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shan","family":"Xiao","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals, Lexington, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Riester","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shibeshih","family":"Belachew","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Deykin","sequence":"additional","affiliation":[{"name":"Upstream Bio, Waltham, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3975-4366","authenticated-orcid":false,"given":"Bing","family":"Zhu","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,9,21]]},"reference":[{"key":"bibr1-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1401483"},{"key":"bibr2-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000622"},{"key":"bibr3-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000005345"},{"key":"bibr4-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000561"},{"key":"bibr5-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-018-0530-8"},{"key":"bibr6-13524585221114997","unstructured":"European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis, https:\/\/www.ema.europa.eu\/documents\/scientific-guideline\/guideline-clinical-investigation-medicinal-products-treatment-multiple-sclerosis_en-0.pdf (2015, accessed 19 February 2019)."},{"key":"bibr7-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2377-14-58"},{"key":"bibr8-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-017-0412-5"},{"key":"bibr9-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1756285610374117"},{"key":"bibr10-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458509106212"},{"key":"bibr11-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.33.11.1444"},{"key":"bibr12-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(12)70059-5"},{"key":"bibr13-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2015.04.001"},{"key":"bibr14-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458519845108"},{"key":"bibr15-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.42.4.859"},{"key":"bibr16-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/123.5.1027"},{"key":"bibr17-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000436065.97642.d2"},{"key":"bibr18-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690824"},{"key":"bibr19-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1080\/09084280701319938"},{"key":"bibr20-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/135245859900500409"},{"key":"bibr21-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690821"},{"key":"bibr22-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690822"},{"key":"bibr23-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008519"},{"key":"bibr24-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458516638941"},{"key":"bibr25-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(18)30069-3"},{"key":"bibr26-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517723718"},{"key":"bibr27-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30137-1"},{"key":"bibr28-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044397"},{"key":"bibr29-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199303000-00006"},{"key":"bibr30-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/124.5.962"},{"key":"bibr31-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-444-52001-2.00014-5"},{"key":"bibr32-13524585221114997","doi-asserted-by":"publisher","DOI":"10.1177\/1352458511399611"},{"key":"bibr33-13524585221114997","first-page":"118","volume":"20","author":"Dong Q","year":"2014","journal-title":"Mult Scler"},{"key":"bibr34-13524585221114997","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1177\/1352458516650737","volume":"22","author":"Giovannoni G","year":"2016","journal-title":"Mult Scler J"},{"key":"bibr35-13524585221114997","unstructured":"European Medicines Agency. 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