{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T19:53:24Z","timestamp":1785873204022,"version":"3.56.0"},"reference-count":13,"publisher":"SAGE Publications","issue":"13","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Bristol Myers Squibb"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Ozanimod, a selective, oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for adults with relapsing forms of multiple sclerosis (RMS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To characterize the long-term safety and efficacy of ozanimod.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Participants were eligible for an open-label extension study of ozanimod 0.92\u2009mg\/d (DAYBREAK) if they completed a phase 1\u20133 RMS ozanimod \u2018parent\u2019 trial. DAYBREAK began 16 October 2015, and ended 5 January 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>DAYBREAK included 2494 participants with a mean of 60.9 (range 0.03\u201281.5) months of ozanimod exposure. During DAYBREAK, 2219 participants (89.0%) had treatment-emergent adverse events (TEAEs), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued treatment due to TEAEs. Serious infections (4.3%), herpes zoster infections (2.0%), confirmed macular oedema cases (0.2%), and cardiac TEAEs (4.1 %) were infrequent. Adjusted annualized relapse rate was 0.098 (95% confidence interval, 0.082\u20120.117). In total, 69.1% of participants remained relapse-free and 84.8% were free from 6-month confirmed disability progression at DAYBREAK completion. Adjusted mean numbers of new\/enlarging T2 lesions\/scan and gadolinium-enhancing lesions were low and remained relatively stable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Long-term ozanimod treatment had a favourable safety and tolerability profile and provided sustained control of clinical and MRI disease activity in participants with RMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registries:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov ID: NCT02576717; EudraCT: 2015-002500-91.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585251382796","type":"journal-article","created":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T10:59:52Z","timestamp":1762340392000},"page":"1557-1571","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial"],"prefix":"10.1177","volume":"31","author":[{"given":"Krzysztof W","family":"Selmaj","sequence":"first","affiliation":[{"name":"Center for Neurology, \u0141\u00f3d\u017a, Poland"},{"name":"Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Steinman","sequence":"additional","affiliation":[{"name":"Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giancarlo","family":"Comi","sequence":"additional","affiliation":[{"name":"Vita-Salute San Raffaele University and Casa di Cura Igea, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7179-0335","authenticated-orcid":false,"given":"Amit","family":"Bar-Or","sequence":"additional","affiliation":[{"name":"Center for Neuroinflammation and Experimental Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"}],"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 and Montr\u00e9al Neurological Institute, McGill University, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich Heine University D\u00fcsseldorf, D\u00fcsseldorf, Germany"},{"name":"Brain and Mind Centre, The University of Sydney, Camperdown, NSW, Australia"},{"name":"Department of Neurology, Medical University of Vienna, Vienna, Austria"},{"name":"Department of Neurology, Palack\u00fd University Olomouc, Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Montalb\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Neurology, Centre d'Esclerosi M\u00faltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva K","family":"Havrdov\u00e1","sequence":"additional","affiliation":[{"name":"Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty and General University Hospital, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James K","family":"Sheffield","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Krakovich","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chun-Yen","family":"Cheng","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon V","family":"Riolo","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chahin","family":"Pachai","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Princeton, NJ, 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Dublin: Bristol-Myers Squibb Pharma 2024."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13476"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00018-1"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458518789884"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30238-8"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30239-X"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/13524585221102584"},{"key":"e_1_3_3_10_2","first-page":"64","volume":"1","author":"Ozanimod long-term safety and efficacy: Results from the recently completed DAYBREAK extension trial [infographic]","year":"2024","unstructured":"Ozanimod long-term safety and efficacy: Results from the recently completed DAYBREAK extension trial [infographic]. 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