{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T08:00:55Z","timestamp":1792051255122,"version":"4.4.0"},"reference-count":32,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T00:00:00Z","timestamp":1703635200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Vedolizumab (VDZ) is a well-established and important therapeutic option in the treatment of patients with inflammatory bowel disease (IBD). However, the significance of therapeutic drug monitoring (TDM) with VDZ remains a contradictory field in daily clinical practice. Our study aims to clarify the predictive impact of VDZ drug levels in long-term clinical outcomes in a real-world cohort. Methods: Patients with moderate to severe ulcerative colitis (UC) and Crohn\u2019s disease (CD) from a tertiary IBD referral center at the University Hospital Augsburg, Germany, were enrolled in this single-center retrospective data analysis. Clinical and endoscopic data were collected at month 6, month 12, and at the last time of follow-up, and outcomes were correlated with VDZ levels at week 6. Results: This study included 95 patients, 68.4% (n = 65) with UC, 24.2% (n = 23) with CD, and 7.4% (n = 7) with indeterminate colitis (CI). Patients with a mean VDZ treatment time of 17.83 months \u00b1 14.56 showed clinical response in 29.5% (n = 28) and clinical remission in 45.3% (n = 43) at the end of the study. Endoscopic response occurred in 20.0% (n = 19) and endoscopic remission in 29.5% (n = 28) at the end of the study. The sustained beneficial effect of VDZ was also reflected in a significant change in biomarker levels. VDZ trough level at week 6 was determined in 48.4% (n = 46) with a mean of 41.79 \u00b5g\/mL \u00b1 24.58. A significant association between VDZ level at week 6 and both short and long-term outcomes could not be demonstrated. However, numerically higher VDZ levels were seen in patients with endoscopic and clinical improvement at month 6 and at the time of last follow-up. Conclusions: This study demonstrated efficacy and safety for VDZ in a real-world cohort. Although, for some parameters, a clear trend for higher VDZ levels at week 6 was seen, the efficacy of VDZ was not significantly correlated to VDZ level at week 6, which questions the predictive value of VDZ levels in the real world.<\/jats:p>","DOI":"10.3390\/jcm13010140","type":"journal-article","created":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T02:58:12Z","timestamp":1703645892000},"page":"140","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy and Safety of Vedolizumab in Patients with Inflammatory Bowel Disease in Association with Vedolizumab Drug Levels"],"prefix":"10.3390","volume":"13","author":[{"given":"Eva","family":"H\u00fcttemann","sequence":"first","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"},{"name":"Internal Medicine, Kantonsspital St. Gallen, 9007 St. Gallen, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4441-8006","authenticated-orcid":false,"given":"Anna","family":"Muzalyova","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Gr\u00f6hl","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Nagl","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carola","family":"Fleischmann","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"},{"name":"Department of Gastroenterology, Hepatology and Endocrinology, Klinikum N\u00fcrnberg, 90419 Nuremberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alanna","family":"Ebigbo","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2611-6074","authenticated-orcid":false,"given":"Johanna","family":"Classen","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Wanzl","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friederike","family":"Prinz","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Mayr","sequence":"additional","affiliation":[{"name":"Internal Medicine II, University Hospital Augsburg, 86156 Augsburg, Germany"},{"name":"Department of Oncology and Hematology, Kantonsspital St. Gallen, 9007 St. Gallen, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Schnoy","sequence":"additional","affiliation":[{"name":"Internal Medicine III, University Hospital Augsburg, 86156 Augsburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1053\/j.gastro.2011.10.001","article-title":"Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review","volume":"142","author":"Molodecky","year":"2012","journal-title":"Gastroenterology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"113","DOI":"10.25122\/jml-2018-0075","article-title":"A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease","volume":"12","author":"Seyedian","year":"2019","journal-title":"J. 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Crohn\u2019s Colitis"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/1\/140\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:42:27Z","timestamp":1760132547000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/1\/140"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,27]]},"references-count":32,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,1]]}},"alternative-id":["jcm13010140"],"URL":"https:\/\/doi.org\/10.3390\/jcm13010140","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,27]]}}}