{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:23:21Z","timestamp":1788809001706,"version":"build-2803163510"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T00:00:00Z","timestamp":1763769600000},"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"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Older adults with ulcerative colitis (UC) have unique treatment challenges. Ozanimod is approved for the treatment of moderately to severely active UC in adults based on the phase 3 True North (TN) study results. Here, we analyzed the impact of patient age on ozanimod safety and efficacy in TN and during the open-label extension (OLE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were stratified by age at TN baseline: &amp;lt;40, 40 to 60, and &amp;gt;60\u2009years (cutoff: 75\u2009years). Safety was evaluated in all patients during TN and the OLE; efficacy was assessed at weeks 10 and 52 in TN and up to OLE week 190 in patients who entered as TN week 52 ozanimod clinical responders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 1012 patients analyzed, 492 were &amp;lt;40 years of age, 404 were 40 to 60 years of age, and 116 were &amp;gt;60\u2009years of age. Infection, malignancy, cardiac events, and macular edema were low throughout TN across all ages. Exposure-adjusted incidence rates (EAIRs) of opportunistic and serious infections increased with age during the OLE. Patients \u226540 years of age had higher hypertension EAIRs than those &amp;lt;40 years of age, but EAIRs of other cardiovascular TEAEs were low. No cases of progressive multifocal leukoencephalopathy occurred over 242\u2009weeks of ozanimod exposure. Efficacy rates for evaluated clinical and mucosal endpoints at weeks 10 and 52 with ozanimod were generally consistent across age groups with the overall population; similar trends were observed in the OLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ozanimod safety was similar and efficacy was generally comparable across age groups, although statistical significance vs placebo was not achieved in patients &amp;gt;60 years of age.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izaf258","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T12:09:18Z","timestamp":1759925358000},"page":"512-525","source":"Crossref","is-referenced-by-count":2,"title":["Safety and Efficacy of Ozanimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Age"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1571-5856","authenticated-orcid":false,"given":"Adam S","family":"Faye","sequence":"first","affiliation":[{"name":"NYU Langone Health , New York, NY,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"University of Chicago Medicine Inflammatory Bowel Disease Center , Chicago, IL,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corey A","family":"Siegel","sequence":"additional","affiliation":[{"name":"Walter and Carole Young Center for Digestive Health, Dartmouth-Hitchcock Medical Center , Lebanon, NH,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Millie D","family":"Long","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of North Carolina at Chapel Hill , Chapel Hill, NC,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nabeel","family":"Khan","sequence":"additional","affiliation":[{"name":"Corporal Michael J. Crescenz VA Medical Center , Philadelphia, PA,","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":"Peter M","family":"Irving","sequence":"additional","affiliation":[{"name":"Guy\u2019s and St Thomas\u2019 NHS Foundation Trust , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond K","family":"Cross","sequence":"additional","affiliation":[{"name":"Institute for Digestive Health and Liver Disease, Mercy Medical Center , Baltimore, MD,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Blumenstein","sequence":"additional","affiliation":[{"name":"Medical Clinic 1, Frankfurt University Hospital, Goethe University Frankfurt , Frankfurt,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Armuzzi","sequence":"additional","affiliation":[{"name":"IBD Center, IRCCS Humanitas Research Hospital , Rozzano,","place":["Italy"]},{"name":"Department of Biomedical Sciences, Humanitas University , Pieve Emanuele,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara N","family":"Horst","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center , Nashville, TN,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[{"name":"Agaplesion Markus Hospital, Goethe University , Frankfurt,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2073-4234","authenticated-orcid":false,"given":"Taku","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Kitasato University Kitasato Institute Hospital , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garrett","family":"Lawlor","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":"AnnKatrin","family":"Petersen","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Princeton, NJ,","place":["United 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