{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:35:07Z","timestamp":1791999307367,"version":"4.4.0"},"reference-count":31,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2025,12,26]],"date-time":"2025-12-26T00:00:00Z","timestamp":1766707200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"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":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Opicinumab, a human monoclonal antibody against LINGO-1, is hypothesized to promote remyelination by enhancing the differentiation of oligodendrocyte progenitor cells.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The objective of the study is to investigate the efficacy and safety of opicinumab as an add-on therapy to anti-inflammatory disease-modifying therapies (DMTs) in participants with relapsing multiple sclerosis (RMS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Participants with RMS aged 18\u201358 years, with disease duration up to 20 years, were randomized 1:1 to receive intravenous infusions of placebo or opicinumab every 4 weeks for 72 weeks. Primary endpoint was Overall Disability Response Score (ODRS) over 72 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The study enrolled 263 participants. Adjusted mean difference (95% confidence interval (CI)) on ODRS was 0.15 (\u22120.05 to 0.35;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.148) over 72 weeks, favoring opicinumab versus placebo. Numerically larger differences in favor of opicinumab were observed in participants aged \u2a7e 40 years with Expanded Disability Status Scale \u2a7e 3.0, with disease duration \u2a7e 6 years, and receiving dimethyl fumarate as the background DMT. 85% participants in placebo group and 86% in opicinumab group had adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Although the AFFINITY study did not show significant difference in mean ODRS between opicinumab and placebo groups, data from AFFINITY interpreted with the previous SYNERGY study may inform the design of future remyelination trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinicaltrials.gov identifier:<\/jats:title>\n                    <jats:p>(NCT03222973).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251396433","type":"journal-article","created":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T05:45:57Z","timestamp":1766814357000},"page":"107-120","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety and efficacy of opicinumab in participants with relapsing multiple sclerosis (AFFINITY Part 1): A randomized, controlled, phase 2 trial"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7776-6472","authenticated-orcid":false,"given":"Peter A","family":"Calabresi","sequence":"first","affiliation":[{"name":"Johns Hopkins Hospital, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Giovannoni","sequence":"additional","affiliation":[{"name":"Barts and The London School of Medicine and Dentistry, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Heinrich Heine University, Dusseldorf, Germany; Brain and Mind Center, University of Sydney, Sydney, NSW, Australia"},{"name":"Medical University of Vienna, Vienna, Austria; Palacky University Olomouc, Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0520-4283","authenticated-orcid":false,"given":"Robert T","family":"Naismith","sequence":"additional","affiliation":[{"name":"Washington University, St. Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4263-3717","authenticated-orcid":false,"given":"Robert J","family":"Fox","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6892-104X","authenticated-orcid":false,"given":"Maria Pia","family":"Sormani","sequence":"additional","affiliation":[{"name":"University of Genoa, Genova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4266-0106","authenticated-orcid":false,"given":"Douglas L","family":"Arnold","sequence":"additional","affiliation":[{"name":"NeuroRx Research, McGill University, Montreal, QC, Canada"},{"name":"Montreal Neurological Institute, McGill University, Montreal, QC, Canada"}],"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, University Hospital Basel, University of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Valis","sequence":"additional","affiliation":[{"name":"Charles University in Prague, Hradec Kr\u00e1lov\u00e9, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott D","family":"Newsome","sequence":"additional","affiliation":[{"name":"Johns Hopkins Hospital, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin I","family":"Belkin","sequence":"additional","affiliation":[{"name":"Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Bartholom\u00e9","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, 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":"Andrija","family":"Javor","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6785-7883","authenticated-orcid":false,"given":"Jennifer","family":"Lyons","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel P","family":"Bradley","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Fisher","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Tagge","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3844-6035","authenticated-orcid":false,"given":"Maria L","family":"Naylor","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":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Franchimont","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bing","family":"Zhu","sequence":"additional","affiliation":[{"name":"Biogen, 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"}]}],"member":"179","published-online":{"date-parts":[[2025,12,26]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1401483"},{"key":"e_1_3_3_3_2","unstructured":"MS and International Federation. What is MS? https:\/\/www.msif.org\/about-ms\/what-is-ms\/ (2021 accessed April 2 2022)"},{"key":"e_1_3_3_4_2","unstructured":"National Multiple Sclerosis Society. Disease-modifying therapies for MS https:\/\/nms2cdn.azureedge.net\/cmssite\/nationalmssociety\/media\/msnationalfiles\/brochures\/brochure-the-ms-disease-modifying-medications.pdf (2023 accessed 27 March 2024)."},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa010994"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(21)00179-4"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awac307"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.4175-06.2007"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1038\/nn1460"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.21581"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-013-0068-8"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.113.211771"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)30377-5"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2024.106185"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30137-1"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1177\/13524585221114997"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690821"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.111.190132"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.redox.2015.04.011"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.2353\/ajpath.2007.060898"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1186\/1742-2094-7-30"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00401-015-1422-3"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1126\/science.aan4665"},{"issue":"8","key":"e_1_3_3_24_2","article-title":"Exploring the use of dimethyl fumarate as microglia modulator for neurodegenerative diseases treatment","volume":"9","author":"Rosito M","year":"2020","unstructured":"Rosito M, Testi C, Parisi G, et al. Exploring the use of dimethyl fumarate as microglia modulator for neurodegenerative diseases treatment. Antioxidants (Basel) 2020; 9(8).","journal-title":"Antioxidants (Basel)"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000001138"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21124312"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.neuro.30.051606.094313"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690823"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517690824"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1002\/acn3.620"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.26441"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-021-22265-2"}],"container-title":["Multiple Sclerosis Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251396433","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13524585251396433","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13524585251396433","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T03:35:16Z","timestamp":1782963316000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13524585251396433"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,26]]},"references-count":31,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1177\/13524585251396433"],"URL":"https:\/\/doi.org\/10.1177\/13524585251396433","relation":{},"ISSN":["1352-4585","1477-0970"],"issn-type":[{"value":"1352-4585","type":"print"},{"value":"1477-0970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,26]]}}}