{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T08:45:57Z","timestamp":1793781957741,"version":"4.6.1"},"reference-count":16,"publisher":"MDPI AG","issue":"24","license":[{"start":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T00:00:00Z","timestamp":1702425600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"INITIALISE-ACS Program Frankfurt","award":["01EO2102"],"award-info":[{"award-number":["01EO2102"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Vedolizumab (VDZ) for subcutaneous (SC) injection was approved for use in Europe in 2020 and the US in 2023. Promising efficacy and tolerability have been proven in pivotal trials. However, real-world data on the SC use of VDZ, especially in patients with active disease, are still lacking. We aimed to determine treatment persistence and the drug\u2019s efficacy in inflammatory bowel disease (IBD) patients with active disease in comparison to patients in clinical remission. Methods: Patients treated for IBD in a tertiary care center from July 2020 to December 2021 were included in this study. Clinical and biochemical parameters and data on treatment adherence were collected. VDZ trough levels and disease activity before and after the switch from intravenous (IV) to SC injections were monitored during routine checkups and were retrospectively analyzed. The patients were followed up until week 20. Results: Eighty-two patients were included in the study. Of them, 35 patients had active disease (35\/82 = 43%) at the time of the switch and 47 patients (47\/82 = 57%) were in remission. In total, 10 patients experienced switch failure, 5 were switched back to IV VDZ, and 5 were swapped to a different biologic agent. We observed an increase in VDZ trough levels from the switch to week 8 and from the switch to week 20 in the remission group. Vedolizumab trough levels of 7.4, 51.4, and 33.45 ug\/mL at the switch, week 8, and week 20 were identified to discriminate between remission and disease activity in our cohort. There was no new safety signal detected during the study period. Conclusions: The switch from IV to SC VDZ proved to be efficient, safe, and even capable of reducing residual disease activity.<\/jats:p>","DOI":"10.3390\/jcm12247657","type":"journal-article","created":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T08:55:16Z","timestamp":1702457716000},"page":"7657","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Switching Vedolizumab from IV to SC Injection in Inflammatory Bowel Disease Patients with Active Disease: Real-World Experience from a German IBD Cohort"],"prefix":"10.3390","volume":"12","author":[{"given":"Alica","family":"Kubesch","sequence":"first","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Kruse","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Jungheim","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00dcmniye","family":"Balaban","sequence":"additional","affiliation":[{"name":"Institute of Biostatistics and Mathematical Modeling, University Hospital, Goethe University, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Stratmann","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Sprinzl","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antje","family":"Dienethal","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Krause","sequence":"additional","affiliation":[{"name":"Gastroenterologie Opernstrasse, 34117 Kassel, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Zeuzem","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Blumenstein","sequence":"additional","affiliation":[{"name":"Goethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1093\/ecco-jcc\/jjab178","article-title":"ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment","volume":"16","author":"Raine","year":"2022","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1093\/ecco-jcc\/jjz180","article-title":"ECCO Guidelines on Therapeutics in Crohn\u2019s Disease: Medical Treatment","volume":"14","author":"Torres","year":"2020","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1570","DOI":"10.1053\/j.gastro.2020.12.031","article-title":"STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD","volume":"160","author":"Turner","year":"2021","journal-title":"Gastroenterology"},{"key":"ref_4","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."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"S46","DOI":"10.1093\/ecco-jcc\/jju027.068","article-title":"Relationship between vedolizumab pharmacokinetics and endoscopic outcomes in patients with ulcerative colitis","volume":"9","author":"Rosario","year":"2015","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1437","DOI":"10.1093\/ecco-jcc\/jjw092","article-title":"An overview of the mechanism of action of the monoclonal antibody vedolizumab","volume":"10","author":"Wyant","year":"2016","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1053\/j.gastro.2019.08.027","article-title":"Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients with Ulcerative Colitis","volume":"158","author":"Sandborn","year":"2020","journal-title":"Gastroenterology"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1093\/ecco-jcc\/jjab133","article-title":"Efficacy and Safety of Subcutaneous Vedolizumab in Patients with Moderately to Severely Active Crohn\u2019s Disease: Results From the VISIBLE 2 Randomised Trial","volume":"16","author":"Vermeire","year":"2022","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_9","unstructured":"European Medicines Agency Entyvio (2023, June 01). Entyvio (Vedolizumab) An overview of Entyvio and Why It Is Authorised in the EU, Available online: https:\/\/www.ema.europa.eu\/en\/documents\/overview\/entyvio-epar-summary-public_en.pdf."},{"key":"ref_10","first-page":"jjab224","article-title":"Transitioning from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease (TRAVELESS)","volume":"16","author":"Ventress","year":"2021","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"514","DOI":"10.1016\/S0140-6736(80)92767-1","article-title":"A simple index of Crohn\u2019s-disease activity","volume":"1","author":"Harvey","year":"1980","journal-title":"Lancet"},{"key":"ref_12","unstructured":"(2023, June 01). IGIBD Scores calculator. Available online: https:\/\/www.igibdscores.it\/en\/info-mayo-partial.html."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1389","DOI":"10.1111\/apt.16927","article-title":"Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease","volume":"55","author":"Bergqvist","year":"2022","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1044","DOI":"10.1111\/apt.17153","article-title":"Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases","volume":"56","author":"Volkers","year":"2022","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"863","DOI":"10.1080\/00365521.2023.2176252","article-title":"Switching from intravenous to subcutaneous vedolizumab maintenance treatment in patients with inflammatory bowel disease followed by therapeutic drug monitoring","volume":"58","author":"Wiken","year":"2023","journal-title":"Scand. J. Gastroenterol."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Lim, S.H., Gros, B., Sharma, E., Lehmann, A., Lindsay, J.O., Caulfield, L., Gaya, D.R., Taylor, J., Limdi, J., and Kwok, J. (2023). Safety, Effectiveness, and Treatment Persistence of Subcutaneous Vedolizumab in IBD: A Multicenter Study from the United Kingdom. Inflamm. Bowel Dis.","DOI":"10.1093\/ibd\/izad166"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/24\/7657\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:38:03Z","timestamp":1760132283000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/24\/7657"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,13]]},"references-count":16,"journal-issue":{"issue":"24","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["jcm12247657"],"URL":"https:\/\/doi.org\/10.3390\/jcm12247657","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,13]]}}}