{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:52:06Z","timestamp":1787316726294,"version":"build-2736575974"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2021,6,21]],"date-time":"2021-06-21T00:00:00Z","timestamp":1624233600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Vedolizumab is increasingly used off-label to treat children and adolescents with inflammatory bowel disease (IBD). In the absence of rigorous clinical trial experience, multicenter observational data are important to establish expectations for efficacy and safety. We examined 1-year outcomes following vedolizumab therapy in a large multicenter pediatric IBD cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective study of 159 pediatric patients (4\u201317 years old) with IBD [78, Crohn disease (CD); 81, ulcerative colitis\/IBD-unspecified (UC\/IBD-U)] treated with vedolizumab for 1 year at 8 pediatric medical centers in the United States. Demographics, clinical outcomes, laboratory data, and vedolizumab dosing were recorded. The primary outcome was corticosteroid (CS)-free clinical remission at 1 year. Other measured outcomes were clinical remission at 12 and\/or 24 weeks, laboratory outcomes at 1 year, and endoscopy\/histology results at 1 year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among the 159 patients (mean age, 14.5 \u00b1 2.4 years; 86% anti-TNF experienced), 68\/159 (43%) achieved CS-free clinical remission at 1 year (CD, 35\/78, 45%; UC\/IBD-U, 33\/81, 40%). Vedolizumab therapy failed and was discontinued in 33\/159 (21%) patients prior to 1 year (CD, 18\/78, 23%; UC\/IBD-U, 15\/81, 19%). While week 12 clinical remission was not predictive of 1-year clinical remission in either CD or UC\/IBD-U, week 24 clinical remission was predictive of 1-year clinical remission only in CD patients. No infusion reactions or serious side effects were noted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Vedolizumab was safe and effective in this pediatric population with approximately 43% achieving CS-free clinical remission at 1 year. Similar efficacy was noted in both CD and UC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/crocol\/otab039","type":"journal-article","created":{"date-parts":[[2021,6,19]],"date-time":"2021-06-19T15:08:57Z","timestamp":1624115337000},"source":"Crossref","is-referenced-by-count":13,"title":["Vedolizumab Experience in Children and Adolescents With Inflammatory Bowel Disease: A Multicenter Observational Study"],"prefix":"10.1093","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2706-1204","authenticated-orcid":false,"given":"Temara M","family":"Hajjat","sequence":"first","affiliation":[{"name":"Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children\u2019s Medical Center , Hartford, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maua","family":"Mosha","sequence":"additional","affiliation":[{"name":"Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children\u2019s Medical Center , Hartford, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaitlin G","family":"Whaley","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Cincinnati Children\u2019s Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati College of Medicine , Cincinnati, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Rosen","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Cincinnati Children\u2019s Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati College of Medicine , Cincinnati, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmine","family":"Suppa","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Cohen Children\u2019s Medical Center of NY , New Hyde Park, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Markowitz","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Cohen Children\u2019s Medical Center of NY , New Hyde Park, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Dufour","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Children\u2019s Healthcare of Atlanta , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cary","family":"Sauer","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Children\u2019s Healthcare of Atlanta , Atlanta, Georgia , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Shukla-Udawatta","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Nationwide Children\u2019s Hospital , Columbus, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendan","family":"Boyle","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Nationwide Children\u2019s Hospital , Columbus, Ohio , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meghan","family":"Gibson","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hasbro Children\u2019s Hospital , Providence, Rhode Island , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Shapiro","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, Hasbro Children\u2019s Hospital , Providence, Rhode Island , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derica","family":"Sams","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, University of North Carolina Health Care , Chapel Hill, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Sylvester","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology, University of North Carolina Health Care , Chapel Hill, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Hunter","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology Goryeb Children\u2019s Hospital AHS , Morristown, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria E","family":"Perez","sequence":"additional","affiliation":[{"name":"Division of Pediatric Gastroenterology Goryeb Children\u2019s Hospital AHS , Morristown, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S","family":"Hyams","sequence":"additional","affiliation":[{"name":"Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children\u2019s Medical Center , Hartford, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,6,21]]},"reference":[{"issue":"8","key":"2022111812285640100_CIT0001","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1056\/NEJMoa1215734","article-title":"Vedolizumab as induction and maintenance therapy for ulcerative colitis","volume":"369","author":"Feagan","year":"2013","journal-title":"N Engl J Med."},{"issue":"8","key":"2022111812285640100_CIT0002","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1056\/NEJMoa1215739","article-title":"Vedolizumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"369","author":"Sandborn","year":"2013","journal-title":"N Engl J Med."},{"issue":"3","key":"2022111812285640100_CIT0003","doi-asserted-by":"crossref","first-page":"618","DOI":"10.1053\/j.gastro.2014.05.008","article-title":"Effects of vedolizumab induction therapy for patients with Crohn\u2019s disease in whom tumor necrosis factor antagonist treatment failed","volume":"147","author":"Sands","year":"2014","journal-title":"Gastroenterology."},{"issue":"6","key":"2022111812285640100_CIT0004","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.1093\/ibd\/izy323","article-title":"Sustained clinical remission with vedolizumab in patients with moderate-to-severe ulcerative colitis","volume":"25","author":"Feagan","year":"2019","journal-title":"Inflamm Bowel Dis."},{"issue":"10","key":"2022111812285640100_CIT0005","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1093\/ecco-jcc\/jjx082","article-title":"Vedolizumab in paediatric inflammatory bowel disease: a retrospective multi-center experience from the paediatric IBD Porto group of ESPGHAN","volume":"11","author":"Ledder","year":"2017","journal-title":"J Crohns Colitis"},{"issue":"9","key":"2022111812285640100_CIT0006","doi-asserted-by":"crossref","first-page":"2121","DOI":"10.1097\/MIB.0000000000000865","article-title":"Multi-center experience of vedolizumab effectiveness in pediatric inflammatory bowel disease","volume":"22","author":"Singh","year":"2016","journal-title":"Inflamm Bowel Dis."},{"issue":"10","key":"2022111812285640100_CIT0007","doi-asserted-by":"crossref","first-page":"2425","DOI":"10.1097\/MIB.0000000000000918","article-title":"Vedolizumab therapy in severe pediatric inflammatory bowel disease","volume":"22","author":"Conrad","year":"2016","journal-title":"Inflamm Bowel Dis."},{"issue":"5","key":"2022111812285640100_CIT0008","doi-asserted-by":"crossref","first-page":"653","DOI":"10.1097\/MPG.0b013e31805563f3","article-title":"Differentiating ulcerative colitis from Crohn disease in children and young adults: report of a working group of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and 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