{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T08:00:56Z","timestamp":1792051256001,"version":"4.4.0"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,3,23]],"date-time":"2024-03-23T00:00:00Z","timestamp":1711152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Takeda Canada Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Therapeutic drug monitoring is used to optimize anti-tumour necrosis factor biologic effectiveness in inflammatory bowel disease, but its role with other biological classes is unclear. This study explores relationships between post-induction vedolizumab trough concentrations and biochemical outcomes in a real-world study of individuals with inflammatory bowel disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This retrospective analysis of data from a national patient support program between 2018 and 2020, included 436 individuals with Crohn\u2019s disease or ulcerative colitis receiving vedolizumab. Optimal vedolizumab concentration thresholds (at weeks 6 and 14) were determined based on their ability to predict biochemical normalization (week 30 faecal calprotectin [&amp;lt;250 \u00b5g\/g], C-reactive protein [&amp;lt;5 mg\/l]). Thresholds best associated with each outcome were evaluated in multivariate analyses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among patients with Crohn\u2019s disease, week 6 serum vedolizumab concentrations (&amp;gt;41.65 \u00b5g\/ml) predicted normalization defined by C-reactive protein: Spearman correlation coefficient [\u03c1] = \u22120.26, P = 0.002 and multivariate analysis (MVA)\u2014OR: 3.22, 95% CI: 1.32\u20137.87, P = 0.01, and at week 14 (&amp;gt;22.25 \u00b5g\/ml): \u03c1 = \u22120.38, P &amp;lt; 0.0001, and MVA\u2014OR: 3.21, 95% CI: 1.26\u20138.17 but not faecal calprotectin. Similarly, among patients with ulcerative colitis, week 6 vedolizumab concentrations (&amp;gt;39.65 g\/ml) predicted normalization defined by C-reactive protein: \u03c1 = \u22120.26, P = 0.005 and MVA\u2014OR: 4.03, 95% CI: 1.30\u201312.52, P = 0.016, and at week 14 (&amp;gt;17.35 \u00b5g\/ml): \u03c1 = \u22120.39, P = 0.0001 and MVA\u2014OR: 6.95, 95% CI: 1.81\u201326.77, P = 0.005, but not faecal calprotectin.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Induction and post-induction serum vedolizumab were not consistently associated with biochemical normalization. As such, proactive therapeutic drug monitoring for vedolizumab should not be routinely incorporated in a treat to target strategy for inflammatory bowel disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trial Registration Number<\/jats:title>\n                  <jats:p>NCT04567628.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jcag\/gwae010","type":"journal-article","created":{"date-parts":[[2024,3,24]],"date-time":"2024-03-24T04:29:11Z","timestamp":1711254551000},"page":"290-298","source":"Crossref","is-referenced-by-count":9,"title":["The relationship among vedolizumab drug concentrations, biomarkers of inflammation, and clinical outcomes in a Canadian real-world study"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1551-9054","authenticated-orcid":false,"given":"Cynthia H","family":"Seow","sequence":"first","affiliation":[{"name":"Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Department of Medicine and Community Health Sciences, University of Calgary , Calgary, Alberta , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K","family":"Marshall","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University , Hamilton Ontario , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Stewart","sequence":"additional","affiliation":[{"name":"Pentavere Research Group Inc. , Toronto, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Pettengell","sequence":"additional","affiliation":[{"name":"Pentavere Research Group Inc. , Toronto, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan","family":"Ward","sequence":"additional","affiliation":[{"name":"Takeda Canada Inc. , Toronto, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waqqas","family":"Afif","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, McGill University Health Centre (MUHC), Montreal General Hospital , Montreal, QC , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,3,24]]},"reference":[{"key":"2024081206505845200_CIT0001","first-page":"495","article-title":"Real-world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: a systematic review","volume-title":"J Clin Pharm Ther.","author":"Khan","year":"2019"},{"key":"2024081206505845200_CIT0002","first-page":"162","article-title":"Systematic review with network meta-analysis: first- and second-line pharmacotherapy for moderate-severe ulcerative colitis","volume-title":"Aliment Pharmacol 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Gastroenterol.","author":"Papamichael","year":"2017"},{"key":"2024081206505845200_CIT0007","first-page":"1037","article-title":"Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases","volume-title":"Aliment Pharmacol Ther.","author":"Mitrev","year":"2017"},{"key":"2024081206505845200_CIT0008","first-page":"2014","article-title":"A comprehensive literature review and expert consensus statement on therapeutic drug monitoring of biologics in inflammatory bowel disease","volume-title":"Am J Gastroenterol.","author":"Cheifetz","year":"2021"},{"key":"2024081206505845200_CIT0009","first-page":"937","article-title":"Proactive therapeutic drug monitoring versus conventional management for inflammatory bowel diseases: a systematic review and meta-analysis","volume-title":"Gastroenterology.","author":"Nguyen","year":"2022"},{"key":"2024081206505845200_CIT0010","first-page":"1362","article-title":"Meta-analysis: the efficacy of therapeutic drug monitoring of anti-TNF-therapy in inflammatory bowel disease","volume-title":"Aliment Pharmacol Ther.","author":"Sethi","year":"2023"},{"key":"2024081206505845200_CIT0011","first-page":"127","article-title":"Advances in therapeutic drug monitoring for small-molecule and biologic therapies in inflammatory bowel disease","volume-title":"Curr Treat Options Gastroenterol.","author":"Ma","year":"2019"},{"key":"2024081206505845200_CIT0012","first-page":"906","article-title":"Early vedolizumab trough levels predict mucosal healing in inflammatory bowel disease: a multicentre prospective observational study","volume-title":"Aliment Pharmacol Ther.","author":"Yacoub","year":"2018"},{"key":"2024081206505845200_CIT0013","first-page":"1750","article-title":"Association between low trough levels of vedolizumab during induction therapy for inflammatory bowel diseases and need for additional doses within 6 months","volume-title":"Clin Gastroenterol Hepatol.","author":"Williet","year":"2017"},{"key":"2024081206505845200_CIT0014","first-page":"1","article-title":"Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: current data and future directions","volume-title":"Therap Adv Gastroenterol.","author":"Ward","year":"2018"},{"key":"2024081206505845200_CIT0015","first-page":"580","article-title":"Vedolizumab drug level correlation with clinical remission, biomarker normalization, and mucosal healing in inflammatory bowel disease","volume-title":"Inflamm Bowel Dis.","author":"Al-Bawardy","year":"2019"},{"key":"2024081206505845200_CIT0016","first-page":"195","article-title":"Therapeutic drug monitoring for current and investigational inflammatory bowel disease treatments","volume-title":"J Clin Gastroenterol.","author":"Lee","year":"2021"},{"key":"2024081206505845200_CIT0017","first-page":"3563","article-title":"Association between vedolizumab levels, anti-vedolizumab antibodies, and endoscopic healing index in a large population of patients with inflammatory bowel diseases","volume-title":"Dig Dis Sci.","author":"Yarur","year":"2021"},{"key":"2024081206505845200_CIT0018","first-page":"741","article-title":"Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease","volume-title":"United Eur Gastroenterol J.","author":"Han\u017eel","year":"2019"},{"key":"2024081206505845200_CIT0019","first-page":"1651","article-title":"Vedolizumab concentrations are associated with long-term endoscopic remission in patients with inflammatory bowel diseases","volume-title":"Dig Dis Sci.","author":"Yarur","year":"2019"},{"key":"2024081206505845200_CIT0020","first-page":"478","article-title":"Early vedolizumab trough levels at induction in inflammatory bowel disease patients with treatment failure during maintenance","volume-title":"Eur J Gastroenterol Hepatol.","author":"Liefferinckx","year":"2019"},{"key":"2024081206505845200_CIT0021","first-page":"618","article-title":"Effects of vedolizumab induction therapy for patients with Crohn\u2019s disease in whom tumor necrosis factor antagonist treatment failed","volume-title":"Gastroenterology.","author":"Sands","year":"2014"},{"key":"2024081206505845200_CIT0022","first-page":"921","article-title":"Exposure-efficacy relationships for vedolizumab induction therapy in patients with ulcerative colitis or Crohn\u2019s disease","volume-title":"J Crohns Colitis.","author":"Rosario","year":"2017"},{"key":"2024081206505845200_CIT0023","first-page":"408","article-title":"Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation","volume-title":"Aliment Pharmacol Ther.","author":"Osterman","year":"2019"},{"key":"2024081206505845200_CIT0024","first-page":"848","article-title":"Systematic review with meta-analysis: association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases","volume-title":"Aliment Pharmacol Ther.","author":"Singh","year":"2019"},{"key":"2024081206505845200_CIT0025","first-page":"1189","article-title":"Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease","volume-title":"United Eur Gastroenterol J.","author":"Guidi","year":"2019"},{"key":"2024081206505845200_CIT0026","first-page":"3142","article-title":"Vedolizumab serum trough concentrations and response to dose escalation in inflammatory bowel disease","volume-title":"J Clin Med.","author":"Vaughn","year":"2020"},{"key":"2024081206505845200_CIT0027","first-page":"50","article-title":"Proactive versus reactive therapeutic drug monitoring: Why, When, and How","volume-title":"Inflammatory Intest Dis.","author":"Shmais","year":"2022"},{"key":"2024081206505845200_CIT0028","first-page":"970","article-title":"Vedolizumab trough levels and histological healing during maintenance therapy in ulcerative colitis","volume-title":"J Crohns Colitis.","author":"Pouillon","year":"2019"},{"key":"2024081206505845200_CIT0029","first-page":"1242","article-title":"Update on TDM (Therapeutic Drug Monitoring) with ustekinumab, vedolizumab and tofacitinib in inflammatory bowel disease","volume-title":"J Clin Med.","author":"Restellini","year":"2021"},{"key":"2024081206505845200_CIT0030","first-page":"972","article-title":"Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease patients during maintenance treatment\u2014TUMMY study","volume-title":"Pharmaceutics.","author":"Sivrida\u015f","year":"2023"},{"key":"2024081206505845200_CIT0031","first-page":"410","article-title":"Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn\u2019s disease","volume-title":"JGH 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state-of-the-art overview","volume-title":"BMC Med.","author":"Pouillon","year":"2019"},{"key":"2024081206505845200_CIT0039","first-page":"697","article-title":"Association of vedolizumab level, anti-drug antibodies, and \u03b14\u03b27 occupancy with response in patients with inflammatory bowel diseases","volume-title":"Clin Gastroenterol Hepatol.","author":"Ungar","year":"2018"},{"key":"2024081206505845200_CIT0040","first-page":"117","article-title":"Association of trough vedolizumab levels with clinical, biological and endoscopic outcomes during maintenance therapy in inflammatory bowel disease","volume-title":"Frontline Gastroenterol.","author":"Plevris","year":"2020"},{"key":"2024081206505845200_CIT0041","first-page":"988","article-title":"Tissue exposure does not explain non-response in ulcerative colitis patients with adequate serum vedolizumab concentrations","volume-title":"J Crohns Colitis.","author":"Van den Berghe","year":"2021"},{"key":"2024081206505845200_CIT0042","first-page":"1707","article-title":"Dose optimisation for loss of response to vedolizumab- pharmacokinetics and immune mechanisms","volume-title":"J Crohns Colitis.","author":"Ungar","year":"2021"},{"key":"2024081206505845200_CIT0043","first-page":"1813","article-title":"Vedolizumab tissue concentration correlates to mucosal inflammation and objective treatment response in inflammatory bowel disease","volume-title":"Inflamm Bowel Dis.","author":"Pauwels","year":"2021"},{"key":"2024081206505845200_CIT0044","first-page":"463","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-title":"Aliment Pharmacol Ther.","author":"Vande Casteele","year":"2022"},{"key":"2024081206505845200_CIT0045","first-page":"7","article-title":"A randomized trial of vedolizumab dose optimization in patients with moderate to severe ulcerative colitis who have early nonresponse and high drug clearance: the ENTERPRET trial [DDW abstract 791]","volume":"162","author":"Yarur","year":"2022","journal-title":"Gastroenterology."}],"container-title":["Journal of the Canadian Association of 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