{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:29:21Z","timestamp":1793212161684,"version":"4.5.0"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Takeda UK Ltd, a member of the Takeda group of companies","award":["IISR-2016-101504"],"award-info":[{"award-number":["IISR-2016-101504"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>We conducted a prospective study (FAVOUR) of patients with ulcerative colitis (UC) commencing vedolizumab to investigate fecal vedolizumab loss and its impact on serum levels and treatment outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>FAVOUR recruited patients with moderate-to-severe UC commencing vedolizumab. Fecal vedolizumab levels (FVL) were measured at days 1, 4, and 7 and at weeks 2, 6, and 14. Trough serum vedolizumab levels (SVL) were measured at weeks 2, 6, and 14.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 36 patients were recruited, of whom 33 completed induction therapy. Fecal vedolizumab was detectable in 80\/203 (39%) samples. Statistically significant, positive correlations were observed between FVL and clinical, biochemical, baseline endoscopic, and histologic disease activity at day 1, 4, and 7 as well as weeks 2 and 6. Week 14 clinical non-responders had higher FVL than responders at that timepoint (median 1.0 vs 0.0 \u00b5g\/g, P\u2009=\u2009.004) but not at other timepoints. Area-under-the-curve analysis of FVL was used to quantify cumulative vedolizumab stool loss. This demonstrated significant differences between week 14 clinical responders and non-responders (44 \u00b5g\/g\/day, 95% CI: 0-128 vs 233 \u00b5g\/g\/day, 95% CI 0-1139, P\u2009&amp;lt;\u2009.0001), as well as between endoscopic responders and non-responders (48 \u00b5g\/g\/day, 95% CI 0-142 vs 179 \u00b5g\/g\/day, 95% CI 0-142, P\u2009=\u2009.0017), with non-responders having a higher rate of cumulative loss.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Active UC results in fecal loss of vedolizumab. This correlates with lower SVL and decreased response to treatment. Fecal loss of vedolizumab may be a marker of disease activity and\/or result in lower rates of drug exposure at a tissue level, negatively impacting response.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf159","type":"journal-article","created":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T11:24:19Z","timestamp":1756725859000},"source":"Crossref","is-referenced-by-count":4,"title":["Fecal loss of vedolizumab is associated with ulcerative colitis severity, lower serum vedolizumab levels, and rates of clinical response: results from the FAVOUR study"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4057-9200","authenticated-orcid":false,"given":"Mark A","family":"Samaan","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgina","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel Hsiang","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Dawson","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherine Hermangild","family":"Kottoor","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Imperial College London , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zareen","family":"Bheekhun","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon H","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Mawdsley","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuvra","family":"Ray","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3231-6950","authenticated-orcid":false,"given":"Nick","family":"Powell","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Imperial College London , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krystal","family":"Rawstron","sequence":"additional","affiliation":[{"name":"Synnovis, St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Dart","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arkir","family":"Zehra","sequence":"additional","affiliation":[{"name":"Barts Health NHS Trust, London Pathology Partnership , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0972-8148","authenticated-orcid":false,"given":"Peter M","family":"Irving","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Guy\u2019s & St Thomas\u2019 Hospital , London,","place":["United Kingdom"]},{"name":"School of Immunology and Microbial Sciences, King\u2019s College London , London,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,9,2]]},"reference":[{"key":"2025102819135531600_jjaf159-B1","doi-asserted-by":"publisher","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"},{"key":"2025102819135531600_jjaf159-B2","doi-asserted-by":"publisher","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"},{"key":"2025102819135531600_jjaf159-B3","doi-asserted-by":"publisher","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"},{"key":"2025102819135531600_jjaf159-B4","doi-asserted-by":"publisher","first-page":"1756283X17750355","DOI":"10.1177\/1756283X17750355","article-title":"Immunogenicity of biologics in inflammatory bowel disease","volume":"11","author":"Vermeire","year":"2018","journal-title":"Therap Adv Gastroenterol"},{"key":"2025102819135531600_jjaf159-B5","doi-asserted-by":"crossref","first-page":"645","DOI":"10.2165\/00003088-200746080-00002","article-title":"Clinical pharmacokinetics and use of infliximab","volume":"46","author":"Klotz","year":"2007","journal-title":"Clin Pharmacokinet"},{"key":"2025102819135531600_jjaf159-B6","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1038\/clpt.2011.328","article-title":"Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms","volume":"91","author":"Ordas","year":"2012","journal-title":"Clin Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B7","doi-asserted-by":"publisher","first-page":"1094","DOI":"10.1111\/apt.13175","article-title":"Review article: Applying pharmacokinetics to optimise dosing of anti-TNF biologics in acute severe ulcerative colitis","volume":"41","author":"Rosen","year":"2015","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B8","doi-asserted-by":"publisher","first-page":"188","DOI":"10.1111\/apt.13243","article-title":"Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn\u2019s disease","volume":"42","author":"Rosario","year":"2015","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B9","doi-asserted-by":"publisher","first-page":"350","DOI":"10.1053\/j.gastro.2015.04.016","article-title":"Loss of infliximab into feces is associated with lack of response to therapy in patients with severe ulcerative colitis","volume":"149","author":"Brandse","year":"2015","journal-title":"Gastroenterology"},{"key":"2025102819135531600_jjaf159-B10","doi-asserted-by":"publisher","first-page":"240","DOI":"10.1111\/apt.13238","article-title":"Letter: Stool adalimumab detection in ulcerative colitis and Crohn\u2019s disease","volume":"42","author":"Roblin","year":"2015","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B11","doi-asserted-by":"publisher","first-page":"782","DOI":"10.1136\/gut.2004.056358","article-title":"Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis","volume":"54","author":"Higgins","year":"2005","journal-title":"Gut"},{"key":"2025102819135531600_jjaf159-B12","doi-asserted-by":"publisher","first-page":"1200","DOI":"10.1111\/apt.13408","article-title":"Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials","volume":"42","author":"Jairath","year":"2015","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B13","doi-asserted-by":"publisher","first-page":"1092","DOI":"10.1136\/gutjnl-2013-305600","article-title":"Development and validation of a rapid, generic measure of disease control from the patient\u2019s perspective: the IBD-control questionnaire","volume":"63","author":"Bodger","year":"2014","journal-title":"Gut"},{"key":"2025102819135531600_jjaf159-B14","doi-asserted-by":"publisher","first-page":"S133","DOI":"10.1093\/ecco-jcc\/jjx002.240","article-title":"Fecal loss of infliximab is underestimated due to proteolysis","volume":"11","author":"Strik","year":"2017","journal-title":"J Crohns Colitis"},{"key":"2025102819135531600_jjaf159-B15","doi-asserted-by":"publisher","first-page":"1455","DOI":"10.1080\/17512433.2021.2028619","article-title":"Recent advances in clearance monitoring of monoclonal antibodies in patients with inflammatory bowel diseases","volume":"14","author":"Kantasiripitak","year":"2021","journal-title":"Expert Rev Clin Pharmacol"},{"key":"2025102819135531600_jjaf159-B16","doi-asserted-by":"publisher","first-page":"1077","DOI":"10.1016\/j.cgh.2023.10.029","article-title":"ENTERPRET: a randomized controlled trial of vedolizumab dose optimization in patients with ulcerative colitis who have early nonresponse","volume":"22","author":"Jairath","year":"2024","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2025102819135531600_jjaf159-B17","doi-asserted-by":"publisher","first-page":"700","DOI":"10.1080\/00365521.2019.1619828","article-title":"Pharmacokinetics of golimumab in moderate to severe ulcerative colitis: the GO-KINETIC study","volume":"54","author":"Berends","year":"2019","journal-title":"Scand J Gastroenterol"},{"key":"2025102819135531600_jjaf159-B18","doi-asserted-by":"publisher","first-page":"330","DOI":"10.1016\/j.cgh.2014.07.041","article-title":"An accelerated infliximab induction regimen reduces the need for early colectomy in patients with acute severe ulcerative colitis","volume":"13","author":"Gibson","year":"2015","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2025102819135531600_jjaf159-B19","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1136\/flgastro-2019-101335","article-title":"Comparison of medium to long-term outcomes of acute severe ulcerative colitis patients receiving accelerated and standard infliximab induction","volume":"11","author":"Gibson","year":"2020","journal-title":"Frontline Gastroenterol"},{"key":"2025102819135531600_jjaf159-B20","doi-asserted-by":"publisher","first-page":"981","DOI":"10.1016\/S2468-1253(24)00200-0","article-title":"Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial","volume":"9","author":"Choy","year":"2024","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"2025102819135531600_jjaf159-B21","doi-asserted-by":"publisher","first-page":"188","DOI":"10.1136\/flgastro-2019-101259","article-title":"Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response","volume":"11","author":"Samaan","year":"2020","journal-title":"Frontline Gastroenterol"},{"key":"2025102819135531600_jjaf159-B22","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1111\/apt.16937","article-title":"Real-world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure-response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study","volume":"56","author":"Vande Casteele","year":"2022","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B23","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1111\/apt.15113","article-title":"Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation","volume":"49","author":"Osterman","year":"2019","journal-title":"Aliment Pharmacol Ther"},{"key":"2025102819135531600_jjaf159-B24","doi-asserted-by":"publisher","first-page":"S135","DOI":"10.1093\/ecco-jcc\/jjz203.141","article-title":"\u03b14\u03b27 Receptor occupancy by vedolizumab at trough time-point occurs at the membranal level and is not associated with endoscopic healing in inflammatory bowel disease patients","volume":"14","author":"Ungar","year":"2020","journal-title":"J Crohn\u2019s Colitis"},{"key":"2025102819135531600_jjaf159-B25","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1136\/gutjnl-2014-308099","article-title":"The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study","volume":"65","author":"Yarur","year":"2016","journal-title":"Gut"},{"key":"2025102819135531600_jjaf159-B26","doi-asserted-by":"publisher","first-page":"988","DOI":"10.1093\/ecco-jcc\/jjaa239","article-title":"Tissue exposure does not explain non-response in ulcerative colitis patients with adequate serum vedolizumab concentrations","volume":"15","author":"Van den Berghe","year":"2021","journal-title":"J Crohns Colitis"},{"key":"2025102819135531600_jjaf159-B27","doi-asserted-by":"publisher","first-page":"1610","DOI":"10.1136\/gutjnl-2011-300775","article-title":"Bacterial proteases in IBD and IBS","volume":"61","author":"Steck","year":"2012","journal-title":"Gut"},{"key":"2025102819135531600_jjaf159-B28","doi-asserted-by":"publisher","first-page":"1564","DOI":"10.1053\/j.gastro.2015.07.002","article-title":"Proteolytic cleavage and loss of function of biologic agents that neutralize tumor necrosis factor in the mucosa of patients with inflammatory bowel disease","volume":"149","author":"Biancheri","year":"2015","journal-title":"Gastroenterology"},{"key":"2025102819135531600_jjaf159-B29","doi-asserted-by":"publisher","first-page":"1236","DOI":"10.1136\/bmj.316.7139.1236","article-title":"What\u2019s wrong with Bonferroni adjustments","volume":"316","author":"Perneger","year":"1998","journal-title":"BMJ"}],"container-title":["Journal of Crohn's and Colitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/advance-article-pdf\/doi\/10.1093\/ecco-jcc\/jjaf159\/64191083\/jjaf159.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/19\/9\/jjaf159\/64191083\/jjaf159.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article-pdf\/19\/9\/jjaf159\/64191083\/jjaf159.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T23:14:03Z","timestamp":1761693243000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ecco-jcc\/article\/doi\/10.1093\/ecco-jcc\/jjaf159\/8245818"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":29,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9,28]]}},"URL":"https:\/\/doi.org\/10.1093\/ecco-jcc\/jjaf159","relation":{},"ISSN":["1873-9946","1876-4479"],"issn-type":[{"value":"1873-9946","type":"print"},{"value":"1876-4479","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,9]]},"published":{"date-parts":[[2025,9]]},"article-number":"jjaf159"}}