{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T01:47:12Z","timestamp":1792028832184,"version":"4.4.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T00:00:00Z","timestamp":1770854400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008021","name":"Bristol Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008021","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Peloton Advantage"},{"name":"OPEN Health company"},{"DOI":"10.13039\/100008021","name":"Bristol Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008021","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Ozanimod is a once-daily oral selective sphingosine 1-phosphate receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC) or relapsing multiple sclerosis (RMS). Previous analyses in both indications demonstrated favorable long-term safety profiles of ozanimod. Here we report an integrated analysis of the long-term safety of ozanimod in patients with UC or RMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were pooled in patients with UC who received ozanimod in phase 2, phase 3, and open-label extension (OLE) trials and in patients with RMS who received ozanimod in an OLE trial after completing any phase 1-3 parent trial. Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory abnormalities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 3652 patients with UC or RMS had 16\u2009144 patient-years (PY) of ozanimod exposure over 10\u2009years of follow-up. The most common TEAEs were nasopharyngitis, headache, and coronavirus disease 2019. Rates of TEAEs leading to treatment discontinuation (1.4\/100 PY) and TEAEs of special interest, including serious infections (1.0\/100 PY), herpes zoster (0.5\/100 PY), malignancies (0.4\/100 PY), bradycardia (0.1\/100 PY), sinus bradycardia (0.04\/100 PY), complete atrioventricular block (0.01\/100 PY), and macular edema (0.1\/100 PY), were low. No serious hepatic events or Hy\u2019s law cases occurred. Absolute lymphocyte count of\u2009&amp;lt;\u2009200 cells\/\u00b5L was not temporally associated with serious or opportunistic infections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Long-term exposure to ozanimod is well tolerated in patients with moderate to severe UC or RMS, confirming the previously established safety profile of ozanimod.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registry<\/jats:title>\n                    <jats:p>NCT01647516; NCT02435992; NCT02576717<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izaf319","type":"journal-article","created":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T12:30:44Z","timestamp":1767702644000},"page":"954-962","source":"Crossref","is-referenced-by-count":5,"title":["Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5647-1723","authenticated-orcid":false,"given":"David T","family":"Rubin","sequence":"first","affiliation":[{"name":"University of Chicago Medicine Inflammatory Bowel Disease Center , Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele , Milan,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Nakase","sequence":"additional","affiliation":[{"name":"Sapporo Medical University , Sapporo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan C","family":"Ungaro","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai , New York, NY,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas C","family":"Wolf","sequence":"additional","affiliation":[{"name":"Center for Crohn\u2019s Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates , Atlanta, GA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Alekseeva","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Nizhny Novgorod Regional Clinical Hospital , Nizhny Novgorod,","place":["Russia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"AnnKatrin","family":"Petersen","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaohui","family":"Liu","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimpy","family":"Mehra","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjali","family":"Jain","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark T","family":"Osterman","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Krakovich","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon V","family":"Riolo","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik","family":"DeBoer","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Appio","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Preetika","family":"Sinh","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Medical College of Wisconsin , Milwaukee, WI,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce A 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