{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T18:48:30Z","timestamp":1790707710607,"version":"4.1.0"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,7,31]],"date-time":"2024-07-31T00:00:00Z","timestamp":1722384000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100019832","name":"Gal\u00e1pagos","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019832","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Filgotinib, an oral, once\u2010daily, Janus kinase 1 preferential inhibitor, is an approved treatment for moderately to severely active ulcerative colitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>The aim of this study is to assess the safety and efficacy of continued filgotinib therapy over ~4\u2009years in the long\u2010term extension of the phase 2b\/3 SELECTION trial (SELECTIONLTE; NCT02914535).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this interim analysis of SELECTIONLTE, SELECTION completers (week 10 responders to filgotinib who completed the maintenance study) continued their assigned treatment (double\u2010blind filgotinib 200\u2009mg [FIL200] or filgotinib 100\u2009mg) and SELECTION week 10 non\u2010responders received open\u2010label FIL200. We assessed safety by adverse events (AEs), and efficacy by partial Mayo Clinic Score (pMCS), inflammatory biomarkers and health\u2010related quality of life (HRQoL). We compared safety and efficacy between achievers and non\u2010achievers of a multi\u2010component endpoint, comprehensive disease control (CDC), comprising symptomatic, endoscopic, inflammatory biomarker and HRQoL improvements.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data for completers (<jats:italic>n<\/jats:italic>\u2009=\u2009250) and non\u2010responders (<jats:italic>n<\/jats:italic>\u2009=\u2009372) were reported for \u2264202\u2009weeks. AE occurrences were low and consistent with previous analyses. The as\u2010observed proportion of FIL200\u2010treated patients in pMCS, biomarker and HRQoL remission during SELECTIONLTE remained high among completers (week 144: 80.0%, 86.4% and 86.0%, respectively) and increased among non\u2010responders (week 192: 62.1%, 76.7% and 59.3%, respectively). Significantly higher proportions of CDC achievers at SELECTION week 58 achieved pMCS, IBDQ and corticosteroid\u2010free pMCS remission than non\u2010achievers, up to LTE week 96.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Filgotinib induced and maintained symptomatic remission and improved HRQoL over 4\u2009years. Safety results showed a proven long\u2010term benefit\u2013risk profile. FIL200\u2010treated CDC achievers had better long\u2010term outcomes than non\u2010achievers.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.18158","type":"journal-article","created":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T05:31:56Z","timestamp":1722490316000},"page":"563-584","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Long\u2010term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4\u2009years of follow\u2010up in the SELECTION open\u2010label long\u2010term extension study"],"prefix":"10.1111","volume":"60","author":[{"given":"Brian G.","family":"Feagan","sequence":"first","affiliation":[{"name":"Alimentiv Inc.  London Ontario Canada"},{"name":"Western University  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuyoshi","family":"Matsuoka","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Internal Medicine Toho University Sakura Medical Center  Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerhard","family":"Rogler","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology University Hospital Zurich, University of Zurich  Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4753-6676","authenticated-orcid":false,"given":"David","family":"Laharie","sequence":"additional","affiliation":[{"name":"Gastroenterology Department Hospital Center University de Bordeaux, Magellan Medico\u2010Surgical Center, Haut\u2010L\u00e9v\u00eaque Hospital, University of Bordeaux, INSERM  Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology UZ Leuven  Leuven Belgium"}],"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 Hospital San Raffaele  Milan Italy"},{"name":"Vita\u2010Salute San Raffaele University  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr","given":"Edward V.","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic College of Medicine and Science  Rochester Minnesota 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