{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T02:01:19Z","timestamp":1790647279181,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,9,2]],"date-time":"2020-09-02T00:00:00Z","timestamp":1599004800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","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":[[2020,10]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Vedolizumab, a gut\u2010selective \u03b1<jats:sub>4<\/jats:sub>\u03b2<jats:sub>7<\/jats:sub> integrin antibody, is approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To report the final results from the vedolizumab GEMINI long\u2010term safety (LTS) study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The phase 3, open\u2010label GEMINI LTS study (initiated May 2009) enrolled patients with UC or CD from four prior clinical trials and vedolizumab\u2010na\u00efve patients. Vedolizumab LTS was evaluated; efficacy and patient\u2010reported outcomes were exploratory endpoints.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Enrolled patients (UC, n\u00a0=\u00a0894; CD, n\u00a0=\u00a01349) received vedolizumab 300\u00a0mg IV every 4\u00a0weeks; median cumulative exposure was 42.4\u00a0months (range: 0.03\u2010112.2) for UC and 31.5\u00a0months (range: 0.03\u2010100.3) for CD. Over 8\u00a0years, adverse events (AEs) occurred in 93% (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients. There were no new trends for infections, malignancies, infusion\u2010related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy. Of the ten deaths (UC, n\u00a0=\u00a04; CD, n\u00a0=\u00a06), two were considered drug\u2010related by local investigators (West Nile virus infection\u2010related encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained clinical response long\u2010term, with 33% (UC) and 28% (CD) of patients in clinical remission at 400 treatment weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The safety profile of vedolizumab remains favourable with no unexpected or new safety concerns. These results further establish the safety of vedolizumab and support its long\u2010term use (NCT00790933\/EudraCT 2008\u2010002784\u201014).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16060","type":"journal-article","created":{"date-parts":[[2020,10,7]],"date-time":"2020-10-07T09:35:16Z","timestamp":1602063316000},"page":"1353-1365","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":191,"title":["Long\u2010term safety of vedolizumab for inflammatory bowel disease"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr","given":"Edward V.","family":"Loftus","sequence":"first","affiliation":[{"name":"Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6914-3822","authenticated-orcid":false,"given":"Brian G.","family":"Feagan","sequence":"additional","affiliation":[{"name":"London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Calgary AB Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-249X","authenticated-orcid":false,"given":"Jean\u2010Fr\u00e9d\u00e9ric","family":"Colombel","sequence":"additional","affiliation":[{"name":"New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3314-7960","authenticated-orcid":false,"given":"William J.","family":"Sandborn","sequence":"additional","affiliation":[{"name":"San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5762-5042","authenticated-orcid":false,"given":"Bruce E.","family":"Sands","sequence":"additional","affiliation":[{"name":"New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2784-4046","authenticated-orcid":false,"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5647-1723","authenticated-orcid":false,"given":"David T.","family":"Rubin","sequence":"additional","affiliation":[{"name":"Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ira","family":"Shafran","sequence":"additional","affiliation":[{"name":"Winter Park FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrejus","family":"Parfionovas","sequence":"additional","affiliation":[{"name":"Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Rogers","sequence":"additional","affiliation":[{"name":"Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8342-9942","authenticated-orcid":false,"given":"Richard A.","family":"Lirio","sequence":"additional","affiliation":[{"name":"Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9942-3019","authenticated-orcid":false,"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31711-1"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32126-2"},{"key":"e_1_2_8_4_1","unstructured":"ENTYVIO (vedolizumab) prescribing information. 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