{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T13:02:59Z","timestamp":1793019779184,"version":"4.5.0"},"reference-count":15,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"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":[[2022,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Dimethyl fumarate (DMF) demonstrated favorable benefit\u2013risk in relapsing-remitting multiple sclerosis (RRMS) patients in phase-III DEFINE and CONFIRM trials, and ENDORSE extension.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The main aim of this study is assessing DMF safety\/efficacy up to 13\u2009years in ENDORSE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Randomized patients received DMF 240 mg twice daily or placebo (PBO; Years 0\u20132), then DMF (Years 3\u201310; continuous DMF\/DMF or PBO\/DMF); maximum follow-up (combined studies), 13\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>By January 2020, 1736 patients enrolled\/dosed in ENDORSE (median follow-up 8.76\u2009years (ENDORSE range: 0.04\u201310.98) in DEFINE\/CONFIRM and ENDORSE); 52% treated in ENDORSE for \u2a7e6\u2009years. Overall, 551 (32%) patients experienced serious adverse events (mostly multiple sclerosis (MS) relapse or fall; one progressive multifocal leukoencephalopathy); 243 (14%) discontinued treatment due to adverse events (4% gastrointestinal (GI) disorders). Rare opportunistic infections, malignancies, and serious herpes zoster occurred, irrespective of lymphocyte count. For DMF\/DMF ( n = 501), overall annualized relapse rate (ARR) remained low (0.143 (95% confidence interval (CI), 0.120\u20130.169)), while for PBO\/DMF ( n = 249), ARR decreased after initiating DMF and remained low throughout (ARR 0\u20132\u2009years, 0.330 (95% CI, 0.266\u20130.408); overall ARR (ENDORSE, 0.151 (95% CI, 0.118\u20130.194)). Over 10\u2009years, 72% DMF\/DMF and 73% PBO\/DMF had no 24-week confirmed disability worsening.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Sustained DMF safety\/efficacy was observed in patients followed up to 13\u2009years, supporting DMF\u2019s positive benefit\/risk profile for long-term RRMS treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585211037909","type":"journal-article","created":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T03:33:27Z","timestamp":1630467207000},"page":"801-816","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":80,"title":["Long-term safety and efficacy of dimethyl fumarate for up to 13\u2009years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results"],"prefix":"10.1177","volume":"28","author":[{"given":"Ralf","family":"Gold","sequence":"first","affiliation":[{"name":"Department of Neurology, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany"}],"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":"Montreal Neurological Institute-Hospital, McGill University and NeuroRx Research, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amit","family":"Bar-Or","sequence":"additional","affiliation":[{"name":"Center for Neuroinflammation and Experimental Therapeutics, Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4263-3717","authenticated-orcid":false,"given":"Robert 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