{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T23:18:28Z","timestamp":1777936708397,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2014,7,2]],"date-time":"2014-07-02T00:00:00Z","timestamp":1404259200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate delayed-release DMF in newly diagnosed relapsing\u2013remitting multiple sclerosis (RRMS) patients, in a post-hoc analysis of integrated data from DEFINE and CONFIRM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The newly diagnosed population comprised 678 patients treated with placebo ( n = 223) or delayed-release DMF 240 mg BID ( n = 221) or TID ( n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p &lt; 0.0001), risk of relapse by 54% and 57% (both p &lt; 0.0001), and risk of 12-week confirmed disability progression by 71% ( p &lt; 0.0001) and 47% ( p = 0.0085) versus placebo. In a subset of patients (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p &lt; 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMS patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1352458514537013","type":"journal-article","created":{"date-parts":[[2014,7,2]],"date-time":"2014-07-02T23:04:10Z","timestamp":1404342250000},"page":"57-66","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":51,"title":["Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing\u2013remitting multiple sclerosis (RRMS)"],"prefix":"10.1177","volume":"21","author":[{"given":"Ralf","family":"Gold","sequence":"first","affiliation":[{"name":"St. Josef Hospital, Ruhr University, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gavin","family":"Giovannoni","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J Theodore","family":"Phillips","sequence":"additional","affiliation":[{"name":"Multiple Sclerosis Program, Baylor Institute for Immunology Research, Dallas, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert J","family":"Fox","sequence":"additional","affiliation":[{"name":"Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annie","family":"Zhang","sequence":"additional","affiliation":[{"name":"Biogen Idec, Inc., Cambridge, MA, 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