{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:22:19Z","timestamp":1787008939586,"version":"build-2736575974"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T00:00:00Z","timestamp":1758844800000},"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"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We evaluated the efficacy and safety of ozanimod after 5-aminosalicylic acid (5-ASA) failure in advanced therapy (AT)\u2013naive patients with moderate ulcerative colitis (UC) in True North and its open-label extension (OLE).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>True North was a randomized, 52-week, phase 3 trial with an optional OLE. Efficacy was assessed in True North and the OLE; safety was assessed through OLE week 190.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 203 AT-naive True North patients had moderate UC (Mayo endoscopic subscore of 2\u2009+ modified Mayo score of 4-6\u2009+ rectal bleeding subscore \u22651). Of these, 139 were also immunomodulator-naive and not receiving corticosteroids (5-ASA\u2013exposed only) at baseline. Patients with moderate UC receiving ozanimod vs placebo achieved greater efficacy rates for all week 10 and week 52 outcomes, regardless of prior immunomodulator\/corticosteroid use (eg, week 10 clinical remission: AT-naive\u2009=\u200936.8% vs 10.6%; 5-ASA\u2013exposed only\u2009=\u200937.9% vs 17.2%). Higher symptomatic response rates were achieved by week 2 with ozanimod in AT-naive patients with moderate UC vs the overall AT-naive population (50.5% vs 38.7%); similar trends were observed in patients exposed only to 5-ASA. Efficacy was maintained through OLE week 190 in patients who entered OLE as True North week 52 ozanimod clinical responders. Of those entering OLE as True North week 10 ozanimod clinical nonresponders, 69.0% of AT-naive patients and 68.4% of patients exposed only to 5-ASA achieved symptomatic response by week 5. No new safety signals emerged.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ozanimod was safe, effective, and durable up to \u223c5\u2009years in AT-naive patients with moderate UC who failed conventional therapy. ClinicalTrials.gov: NCT02435992, NCT02531126.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izaf195","type":"journal-article","created":{"date-parts":[[2025,8,6]],"date-time":"2025-08-06T11:43:23Z","timestamp":1754480603000},"page":"77-86","source":"Crossref","is-referenced-by-count":1,"title":["Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2293-5555","authenticated-orcid":false,"given":"Andres","family":"Yarur","sequence":"first","affiliation":[{"name":"Cedars-Sinai Medical Center , Los Angeles, CA 90048,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0972-8148","authenticated-orcid":false,"given":"Peter","family":"Irving","sequence":"additional","affiliation":[{"name":"Guy\u2019s and St Thomas\u2019 NHS Foundation Trust , London SE1 7EH,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0055-958X","authenticated-orcid":false,"given":"Britta","family":"Siegmund","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Infectious Diseases and Rheumatology, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin , 10117 Berlin,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla C","family":"Dubinsky","sequence":"additional","affiliation":[{"name":"Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, Icahn School of Medicine at Mount Sinai , New York, NY 10029,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashwin N","family":"Ananthakrishnan","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital , Boston, MA 02114,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7681-8111","authenticated-orcid":false,"given":"Miguel","family":"Regueiro","sequence":"additional","affiliation":[{"name":"Cleveland Clinic , Cleveland, OH 44195,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan C","family":"Ungaro","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai , New York, NY 10029,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Ritter","sequence":"additional","affiliation":[{"name":"GI Alliance , Southlake, TX 76092,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Nakase","sequence":"additional","affiliation":[{"name":"Sapporo Medical University , Sapporo, Hokkaido 060-8556,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaohui","family":"Liu","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Lawrence Township, NJ 08648,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimpy","family":"Mehra","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Lawrence Township, NJ 08648,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark T","family":"Osterman","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Lawrence Township, NJ 08648,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjali","family":"Jain","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb , Lawrence Township, NJ 08648,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T","family":"Rubin","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, University of Chicago Medicine , Chicago, IL 60637,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshifumi","family":"Hibi","sequence":"additional","affiliation":[{"name":"Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University , Tokyo 108-8642,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,9,26]]},"reference":[{"key":"2026010301015954000_izaf195-B1","doi-asserted-by":"crossref","first-page":"384","DOI":"10.14309\/ajg.0000000000000152","article-title":"ACG clinical guideline: ulcerative colitis in adults","volume":"114","author":"Rubin","year":"2019","journal-title":"Am J Gastroenterol"},{"key":"2026010301015954000_izaf195-B2","doi-asserted-by":"crossref","first-page":"893","DOI":"10.1080\/14656566.2022.2071605","article-title":"An overview of ozanimod as a therapeutic option for adults with moderate-to-severe active ulcerative colitis","volume":"23","author":"Rowan","year":"2022","journal-title":"Expert Opin Pharmacother"},{"key":"2026010301015954000_izaf195-B3","doi-asserted-by":"crossref","first-page":"748","DOI":"10.1053\/j.gastro.2018.12.009","article-title":"AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis","volume":"156","author":"Ko","year":"2019","journal-title":"Gastroenterology"},{"key":"2026010301015954000_izaf195-B4","doi-asserted-by":"crossref","first-page":"3985","DOI":"10.1007\/s10620-020-06704-6","article-title":"Concomitant 5-aminosalicylate therapy in moderate-to-severe ulcerative colitis patients escalated to infliximab is not beneficial","volume":"66","author":"Balram","year":"2021","journal-title":"Dig Dis Sci"},{"key":"2026010301015954000_izaf195-B5","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1159\/000527452","article-title":"Significance of 5-aminosalicylic acid intolerance in the clinical management of ulcerative colitis","volume":"104","author":"Mikami","year":"2023","journal-title":"Digestion"},{"key":"2026010301015954000_izaf195-B6","first-page":"57","article-title":"Optimizing use of 5-ASA in the treatment of ulcerative colitis: Focus on patient compliance and adherence","volume":"1","author":"Bernick","year":"2010","journal-title":"Patient Relat Outcome Meas"},{"key":"2026010301015954000_izaf195-B7","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1093\/ecco-jcc\/jjab178","article-title":"ECCO guidelines on therapeutics in ulcerative colitis: medical treatment","volume":"16","author":"Raine","year":"2022","journal-title":"J Crohns Colitis"},{"key":"2026010301015954000_izaf195-B8","first-page":"768","article-title":"Treatment strategies in inflammatory bowel diseases","volume":"120","author":"Stallmach","year":"2023","journal-title":"Dtsch Arzt Intl"},{"key":"2026010301015954000_izaf195-B9","doi-asserted-by":"crossref","first-page":"2905","DOI":"10.3390\/jcm9092905","article-title":"Key strategies to optimize outcomes in mild-to-moderate ulcerative colitis","volume":"9","author":"Solitano","year":"2020","journal-title":"J Clin Med"},{"key":"2026010301015954000_izaf195-B10","doi-asserted-by":"crossref","first-page":"2216","DOI":"10.1016\/j.clinthera.2017.09.011","article-title":"Long-term systemic corticosteroid exposure: a systematic literature review","volume":"39","author":"Rice","year":"2017","journal-title":"Clin Ther"},{"key":"2026010301015954000_izaf195-B11","doi-asserted-by":"crossref","first-page":"17562848231159452","DOI":"10.1177\/17562848231159452","article-title":"Is there an optimal sequence of biologic therapies for inflammatory bowel disease?","volume":"16","author":"Bressler","year":"2023","journal-title":"Therap Adv Gastroenterol"},{"key":"2026010301015954000_izaf195-B12","doi-asserted-by":"crossref","first-page":"55","DOI":"10.14309\/ajg.0000000000002485","article-title":"A review of available medical therapies to treat moderate-to-severe inflammatory bowel disease","volume":"119","author":"Chang","year":"2024","journal-title":"Am J Gastroenterol"},{"key":"2026010301015954000_izaf195-B13","doi-asserted-by":"crossref","first-page":"5318","DOI":"10.3390\/jcm10225318","article-title":"Primary failure to an anti-TNF agent in inflammatory bowel disease: switch (to a second anti-TNF agent) or swap (for another mechanism of action)?","volume":"10","author":"Gisbert","year":"2021","journal-title":"J Clin Med"},{"key":"2026010301015954000_izaf195-B14","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1053\/j.gastro.2011.10.032","article-title":"Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis","volume":"142","author":"Sandborn","year":"2012","journal-title":"Gastroenterology"},{"key":"2026010301015954000_izaf195-B15","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1056\/NEJMoa1900750","article-title":"Ustekinumab as induction and maintenance therapy for ulcerative colitis","volume":"381","author":"Sands","year":"2019","journal-title":"N Engl J Med"},{"key":"2026010301015954000_izaf195-B16","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1016\/S0140-6736(23)00061-2","article-title":"Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies","volume":"401","author":"Sandborn","year":"2023","journal-title":"Lancet"},{"key":"2026010301015954000_izaf195-B17","doi-asserted-by":"crossref","first-page":"2021","DOI":"10.7573\/dic.2021-11-4","article-title":"Tofacitinib and newer JAK inhibitors in inflammatory bowel disease-where we are and where we are going","volume":"11","author":"Liu","year":"2022","journal-title":"Drugs Context"},{"key":"2026010301015954000_izaf195-B18","doi-asserted-by":"crossref","first-page":"1896","DOI":"10.1093\/ibd\/izz059","article-title":"The role of early biologic therapy in inflammatory bowel disease","volume":"25","author":"Berg","year":"2019","journal-title":"Inflamm Bowel Dis"},{"key":"2026010301015954000_izaf195-B19","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1055\/s-0042-1758047","article-title":"diagnosis and monitoring of ulcerative colitis","volume":"35","author":"Murphy","year":"2022","journal-title":"Clin Colon Rectal Surg"},{"key":"2026010301015954000_izaf195-B20","doi-asserted-by":"crossref","first-page":"1778","DOI":"10.1111\/bph.13476","article-title":"Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity","volume":"173","author":"Scott","year":"2016","journal-title":"Br J Pharmacol"},{"key":"2026010301015954000_izaf195-B21","author":"Zeposia","year":"2024"},{"key":"2026010301015954000_izaf195-B22","author":"Zeposia","year":"2024"},{"key":"2026010301015954000_izaf195-B23","doi-asserted-by":"crossref","first-page":"1280","DOI":"10.1056\/NEJMoa2033617","article-title":"Ozanimod as induction and maintenance therapy for ulcerative colitis","volume":"385","author":"Sandborn","year":"2021","journal-title":"N Engl J Med"},{"key":"2026010301015954000_izaf195-B24","doi-asserted-by":"crossref","first-page":"2084","DOI":"10.1016\/j.cgh.2024.03.042","article-title":"Ozanimod in patients with moderate to severe ulcerative colitis naive to advanced therapies","volume":"22","author":"Sands","year":"2024","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026010301015954000_izaf195-B25","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1093\/ecco-jcc\/jjad146","article-title":"Efficacy and safety of approximately 3 years of continuous ozanimod in moderately to severely active ulcerative colitis: interim analysis of the True North open-label extension","volume":"18","author":"Danese","year":"2024","journal-title":"J Crohns Colitis"},{"key":"2026010301015954000_izaf195-B26","doi-asserted-by":"crossref","first-page":"1307","DOI":"10.1053\/j.gastro.2024.10.001","article-title":"AGA living clinical practice guideline on pharmacological management of moderate-to-severe ulcerative colitis","volume":"167","author":"Singh","year":"2024","journal-title":"Gastroenterology"},{"key":"2026010301015954000_izaf195-B27","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.14309\/ajg.0000000000003463","article-title":"ACG Clinical Guideline Update: ulcerative colitis in adults","volume":"120","author":"Rubin","year":"2025","journal-title":"Am J Gastroenterol"},{"key":"2026010301015954000_izaf195-B28","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000003310","article-title":"Impact of prior biologic exposure on ozanimod efficacy and safety in the phase 3 True North clinical trial","author":"Sands","year":"2025","journal-title":"Am J Gastroenterol"},{"key":"2026010301015954000_izaf195-B29","doi-asserted-by":"crossref","first-page":"15","DOI":"10.2147\/NRR.S427698","article-title":"Ozanimod: a practical review for nurses and advanced practice providers","volume":"14","author":"Rubin","year":"2024","journal-title":"Nurs Res Rev"},{"key":"2026010301015954000_izaf195-B30","doi-asserted-by":"crossref","first-page":"829","DOI":"10.1093\/ibd\/izad120","article-title":"Safety and monitoring of inflammatory bowel disease advanced therapies","volume":"30","author":"Bhat","year":"2024","journal-title":"Inflamm Bowel Dis"},{"key":"2026010301015954000_izaf195-B31","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1136\/gutjnl-2016-312912","article-title":"Next generation of small molecules in inflammatory bowel disease","volume":"66","author":"Olivera","year":"2017","journal-title":"Gut"},{"key":"2026010301015954000_izaf195-B32","doi-asserted-by":"crossref","first-page":"1942","DOI":"10.1093\/ibd\/izab006","article-title":"International perspectives on management of inflammatory bowel disease: opinion differences and similarities between patients and physicians from the IBD GAPPS survey","volume":"27","author":"Rubin","year":"2021","journal-title":"Inflamm Bowel Dis"},{"key":"2026010301015954000_izaf195-B33","author":"Xeljanz","year":"2025"}],"container-title":["Inflammatory Bowel Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/32\/1\/77\/64415335\/izaf195.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article-pdf\/32\/1\/77\/64415335\/izaf195.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,3]],"date-time":"2026-01-03T06:02:06Z","timestamp":1767420126000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ibdjournal\/article\/32\/1\/77\/8266421"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,26]]},"references-count":33,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,9,26]]},"published-print":{"date-parts":[[2026,1,1]]}},"URL":"https:\/\/doi.org\/10.1093\/ibd\/izaf195","relation":{},"ISSN":["1078-0998","1536-4844"],"issn-type":[{"value":"1078-0998","type":"print"},{"value":"1536-4844","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,1]]},"published":{"date-parts":[[2025,9,26]]}}}