{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,11]],"date-time":"2026-11-11T03:17:16Z","timestamp":1794367036396,"version":"4.9.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"vor","delay-in-days":33,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Abivax S.A"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Obefazimod is an oral small molecule that selectively enhances the expression of a single micro-RNA (miRNA), miR-124. Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severely active ulcerative colitis (UC) in a phase 2b induction trial. This analysis presents the 2-year outcome data of the open-label maintenance (OLM) study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients received placebo or obefazimod 25, 50, or 100\u00a0mg once\u2013daily (od) during the induction trial and, irrespective of their clinical response, could enter the 96-week OLM study with obefazimod 50\u00a0mg od. Safety was monitored through monthly visits in the first year and quarterly visits in the second year. Efficacy was assessed at weeks 48 and 96 using nonresponder imputation (NRI) for missing data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 222 eligible patients, 217 were enrolled and 164 (75.6%) completed week 96 of the OLM study. Clinical response was achieved at weeks 48 and 96 in 177 (81.6%) and 158 (72.8%) patients and clinical remission in 119 (54.8%) and 114 (52.5%) of patients. A total of 133 (61.3%) and 128 (59.0%) patients showed endoscopic improvement, and 72 (33.2%) and 78 (35.9%) endoscopic remission. In total, 148\/217 patients (68.2%) reported at least 1 treatment-emergent adverse event (TEAE). The most frequent TEAEs were COVID-19 (14.3%), headache (11.5%), UC (7.8%), and nasopharyngitis (6.9%). No new safety risks emerged over 96 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The 96-week OLM study supports the long-term efficacy and favorable safety profile of obefazimod 50\u00a0mg od. A phase 3 program with obefazimod in patients with moderate-to-severe UC is ongoing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration name\/number<\/jats:title>\n                    <jats:p>A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate-to-severe UC. NCT04023396.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf074","type":"journal-article","created":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T09:10:12Z","timestamp":1747818612000},"source":"Crossref","is-referenced-by-count":22,"title":["Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9942-3019","authenticated-orcid":false,"given":"Severine","family":"Vermeire","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven , Leuven ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josianne","family":"Nitcheu","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Gineste","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aur\u00e9lien","family":"Flatres","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Montpellier ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Santo","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Montpellier ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Didier","family":"Scherrer","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Montpellier ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, INFINY Institute, INSERM NGERE, CHRU Nancy , Vand\u0153uvre-l\u00e8s-Nancy ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parambir S","family":"Dulai","sequence":"additional","affiliation":[{"name":"Feinberg School of Medicine, Northwestern University , 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":"Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele , Milan ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4968-5795","authenticated-orcid":false,"given":"Marla","family":"Dubinsky","sequence":"additional","affiliation":[{"name":"Pediatric GI and Nutrition, Mount Sinai Kravis Children\u2019s Hospital , New York, NY ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herbert","family":"Tilg","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University of Innsbruck , Innsbruck ,","place":["Austria"]}],"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, Infectiology and Rheumatology, Charit\u00e9-Universitaetsmedizin Berlin , Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, Berlin ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1178-3536","authenticated-orcid":false,"given":"Tadakazu","family":"Hisamatsu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Kyorin University Hospital , Tokyo ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kejia","family":"Shan","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J","family":"Rabbat","sequence":"additional","affiliation":[{"name":"Abivax S.A. , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. 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