{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T16:39:37Z","timestamp":1790699977411,"version":"4.1.0"},"reference-count":29,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2016,7,11]],"date-time":"2016-07-11T00:00:00Z","timestamp":1468195200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favorable benefit\u2013risk profile for patients with relapsing\u2013remitting multiple sclerosis (RRMS) in phase 3 DEFINE\/CONFIRM studies. ENDORSE is an ongoing long-term extension of DEFINE\/CONFIRM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>We report efficacy and safety results of a 5-year interim analysis of ENDORSE (2\u2009years DEFINE\/CONFIRM; minimum 3\u2009years ENDORSE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In ENDORSE, patients randomized to DMF 240\u2009mg twice (BID) or thrice daily (TID) in DEFINE\/CONFIRM continued this dosage, and those initially randomized to placebo (PBO) or glatiramer acetate (GA) were re-randomized to DMF 240\u2009mg BID or TID.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>For patients continuing DMF BID (BID\/BID), annualized relapse rates were 0.202, 0.163, 0.139, 0.143, and 0.138 (years 1\u20135, respectively) and 63%, 73%, and 88% were free of new or enlarging T2 hyperintense lesions, new T1 hypointense lesions, and gadolinium-enhanced lesions, respectively, at year 5. Adverse events (AEs; serious adverse events (SAEs)) were reported in 91% (22%; BID\/BID), 95% (24%; PBO\/BID), and 88% (16%; GA\/BID) of the patients. One case of progressive multifocal leukoencephalopathy was reported in the setting of severe, prolonged lymphopenia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Treatment with DMF was associated with continuously low clinical and magnetic resonance imaging (MRI) disease activity in patients with RRMS. These interim data demonstrate a sustained treatment benefit and an acceptable safety profile with DMF.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1352458516649037","type":"journal-article","created":{"date-parts":[[2016,5,20]],"date-time":"2016-05-20T05:31:29Z","timestamp":1463722289000},"page":"253-265","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":131,"title":["Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study"],"prefix":"10.1177","volume":"23","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"}]},{"given":"Douglas L","family":"Arnold","sequence":"additional","affiliation":[{"name":"NeuroRx Research, Montreal, QC, Canada\/Montreal Neurological Institute, McGill University, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amit","family":"Bar-Or","sequence":"additional","affiliation":[{"name":"Montreal Neurological Institute, McGill University, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hutchinson","sequence":"additional","affiliation":[{"name":"St. Vincent\u2019s University Hospital, Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludwig","family":"Kappos","sequence":"additional","affiliation":[{"name":"Department of Neurology, University Hospital of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Havrdova","sequence":"additional","affiliation":[{"name":"Department of Neurology, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G","family":"MacManus","sequence":"additional","affiliation":[{"name":"NMR Research Unit, Queen Square Multiple Sclerosis Centre, University College London (UCL) Institute of Neurology, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek A","family":"Yousry","sequence":"additional","affiliation":[{"name":"NMR Research Unit, Queen Square Multiple Sclerosis Centre, University College London (UCL) Institute of Neurology, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Pozzilli","sequence":"additional","affiliation":[{"name":"Department of Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krysztof","family":"Selmaj","sequence":"additional","affiliation":[{"name":"Medical University of Lodz, Lodz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne T","family":"Sweetser","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ray","family":"Zhang","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minhua","family":"Yang","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Potts","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Novas","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David H","family":"Miller","sequence":"additional","affiliation":[{"name":"NMR Research Unit, Queen Square Multiple Sclerosis Centre, University College London (UCL) Institute of Neurology, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuwan C","family":"Kurukulasuriya","sequence":"additional","affiliation":[{"name":"Biogen, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J","family":"Fox","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodore J","family":"Phillips","sequence":"additional","affiliation":[{"name":"Baylor Institute for Immunology Research, Multiple Sclerosis Program, Dallas, TX, 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