{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T03:36:21Z","timestamp":1793849781216,"version":"4.6.1"},"reference-count":30,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100031585","name":"Takeda Development Center Americas","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100031585","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Vedolizumab is a gut-selective, anti-\u03b1\n                      <jats:sub>4<\/jats:sub>\n                      \u03b2\n                      <jats:sub>7<\/jats:sub>\n                      integrin antibody treatment for ulcerative colitis (UC) and Crohn\u2019s disease (CD).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>Long-term vedolizumab treatment persistence and safety were evaluated in patients who completed GEMINI LTS (NCT00790933) or VERSIFY (NCT02425111) clinical trials and continued treatment in the open-label vedolizumab extended access program (XAP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>A phase IIIb\/IV clinical study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This phase IIIb\/IV, prospective, multinational study (NCT02743806) was conducted from August 2016 to January 2023 in adults with UC\/CD treated with vedolizumab 300\u2009mg intravenous every 8\/4\u2009weeks (Q8W\/Q4W).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of 331 (UC, 142; CD, 189) patients enrolled, 311 from GEMINI LTS (UC, 142; CD, 169) and 20 with CD from VERSIFY, most (295\/331) started the XAP study on Q8W dosing (UC, 93% (132\/142); CD, 86% (163\/189)). The mean (SD) disease duration at XAP study baseline was 14 (7)\u2009years for UC and 3 (7)\u2009years for CD. Vedolizumab Q8W treatment persistence for \u2a7e6\u2009months without relapse was 98% (129\/132) for UC and 95% (154\/163) for CD. Twenty-seven patients (9%) were re-escalated from Q8W to Q4W dosing: UC, 8% (11\/132); CD, 10% (16\/163). The mean (SD) vedolizumab treatment duration in the XAP was 3.5 (1.6)\u2009years for UC and 3.6 (1.7)\u2009years for CD. In the UC and CD groups, 13% and 16% of patients had serious adverse events (SAEs), respectively (1% per group was treatment related); two (1%) and four (2%) had serious infections, respectively, none related to treatment. One patient died from chronic obstructive pulmonary disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this prospective longitudinal study, patients had high persistence with vedolizumab Q8W. SAE, relapse, and reescalation to Q4W dosing rates were low.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>\n                      The study protocol was registered at ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">https:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n                      ; NCT02743806).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562848251406092","type":"journal-article","created":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T07:57:54Z","timestamp":1770710274000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety"],"prefix":"10.1177","volume":"19","author":[{"given":"Silvio","family":"Danese","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, University Vita-Salute, San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milan","family":"Luk\u00e1\u0161","sequence":"additional","affiliation":[{"name":"IBD Clinical and Research Centre, ISCARE Clinical Centre, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miroslava","family":"Volfov\u00e1","sequence":"additional","affiliation":[{"name":"Hepato-Gastroenterologie HK, Gastroenterology Private Clinic, Hradec Kralove, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gra\u017cyna","family":"Rydzewska","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, National Medical Institute of Ministry of Interior and Administration, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shashi","family":"Adsul","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Lindner","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals AG, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Jones","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc., 500 Kendall Street, Cambridge, MA 02142, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,2,9]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-021-01604-z"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0904492"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215734"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1602773"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2015.135"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijso.2019.11.010"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11938-014-0044-5"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S171363"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-018-5385-9"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-073071"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1586\/17474124.2014.882768"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2019-002133"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.109.153973"},{"key":"e_1_3_5_15_2","unstructured":"Takeda Pharmaceuticals USA Inc. 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