{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T23:06:33Z","timestamp":1788822393659,"version":"build-2803163510"},"reference-count":14,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background\/Objectives: Two clinical decision support tools (CDSTs) have been developed to predict treatment effectiveness of vedolizumab in Crohn\u2019s disease (CD) and ulcerative colitis (UC). This study aimed to validate the CDSTs with real-world data from a Dutch teaching hospital. Methods: Patients with CD or UC treated with vedolizumab between October 2014 and July 2023 were included. IBD patients treated with ustekinumab were included to study the specificity of the CDSTs. The primary outcomes were rates of clinical remission (CREM), biochemical remission (BioREM), composite (either clinical or biochemical) remission (CompREM) and corticosteroid-free clinical remission (CSF-CREM) at week 14, 30 and 54. Results: 32 CD patients and 41 UC patients treated with vedolizumab were included, as well as 28 CD patients treated with ustekinumab and 41 UC patients treated with vedolizumab. Among UC patients treated with vedolizumab, rates of CREM, CompREM and CSF-CREM at week 54 were statistically significantly higher in the group with high probability of response compared to the group with low + intermediate probability of response (CREM 33.3% vs. 81.8% p = 0.003; CompREM 33.3% vs. 86.4% p &lt; 0.001; CSF-CREM 22.2% vs. 77.3% p = 0.001). For both CD patients treated with vedolizumab and CD patients treated with ustekinumab, no statistically significant differences were found between low + intermediate and high probability groups for all outcomes. Conclusions: The CDST for UC is able to predict various effectiveness outcomes for treatment with vedolizumab and can therefore help in the selection of optimal treatment for patients with UC. For CD patients treated with vedolizumab, the CDST could not predict effectiveness outcomes.<\/jats:p>","DOI":"10.3390\/pharmaceutics18010015","type":"journal-article","created":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T11:30:18Z","timestamp":1766489418000},"page":"15","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Retrospective Validation of Clinical Decision Support Tools for Predicting Effectiveness Outcomes in Inflammatory Bowel Disease Patients Treated with Vedolizumab"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9711-3946","authenticated-orcid":false,"given":"Paul A. G.","family":"de Klaver","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology, M\u00e1xima Medical Center, 5504 DB Veldhoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amber M. H.","family":"van Woerkens","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology, M\u00e1xima Medical Center, 5504 DB Veldhoven, The Netherlands"},{"name":"Department of Pharmaceutical Sciences, Utrecht University, 3584 CG Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hedwig M. A.","family":"D\u2019Agnolo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, M\u00e1xima Medical Center, 5504 DB Veldhoven, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marieke J.","family":"Pierik","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"},{"name":"School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6229 ER Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc J. J.","family":"Derijks","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology, M\u00e1xima Medical Center, 5504 DB Veldhoven, The Netherlands"},{"name":"School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6229 ER Maastricht, The Netherlands"},{"name":"Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Center, 6229 HX Maastricht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Morton, H., Pedley, K.C., Stewart, R.J.C., and Coad, J. (2020). Inflammatory Bowel Disease: Are Symptoms and Diet Linked?. Nutrients, 12.","DOI":"10.3390\/nu12102975"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.1002\/ueg2.12138","article-title":"Trends in inflammatory bowel disease treatment in the past two decades-a high-level text mining analysis of PubMed publications","volume":"9","author":"Klang","year":"2021","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1177\/2040622319899297","article-title":"Emerging treatments for inflammatory bowel disease","volume":"11","author":"Hazel","year":"2020","journal-title":"Ther. Adv. Chronic Dis."},{"key":"ref_4","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_5","unstructured":"(2025, July 10). European Crohn\u2019s and Colitis Organisation, Interventions Vedolizumab. Available online: https:\/\/www.e-guide.ecco-ibd.eu\/interventions-therapeutic\/vedolizumab."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1053\/j.gastro.2018.05.039","article-title":"Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients with Crohn\u2019s Disease","volume":"155","author":"Dulai","year":"2018","journal-title":"Gastroenterology"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"2952","DOI":"10.1016\/j.cgh.2020.02.010","article-title":"Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment with Vedolizumab in Patients With Ulcerative Colitis","volume":"18","author":"Dulai","year":"2020","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1111\/apt.17989","article-title":"Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study","volume":"59","author":"Kim","year":"2024","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1093\/ibd\/izab060","article-title":"Vedolizumab Clinical Decision Support Tool Predicts Efficacy of Vedolizumab but Not Ustekinumab in Refractory Crohn\u2019s Disease","volume":"28","author":"Alric","year":"2022","journal-title":"Inflamm. Bowel Dis."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Scarozza, P., Marafini, I., Laudisi, F., Troncone, E., Schmitt, H., Lenti, M.V., Costa, S., Rocchetti, I., De Cristofaro, E., and Salvatori, S. (2020). Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab. J. Clin. Med., 9.","DOI":"10.3390\/jcm9020385"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1555","DOI":"10.1093\/ibd\/izab310","article-title":"Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission with Vedolizumab vs Adalimumab","volume":"28","author":"Dulai","year":"2022","journal-title":"Inflamm. Bowel Dis."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"6385","DOI":"10.3748\/wjg.v23.i35.6385","article-title":"Time to clinical response and remission for therapeutics in inflammatory bowel diseases: What should the clinician expect, what should patients be told?","volume":"23","author":"Vasudevan","year":"2017","journal-title":"World J. Gastroenterol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1216","DOI":"10.1016\/j.cgh.2024.09.020","article-title":"Calibration, Clinical Utility, and Specificity of Clinical Decision Support Tools in Inflammatory Bowel Disease","volume":"23","author":"Alsoud","year":"2025","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_14","unstructured":"Choon, X.Y.W.C., Sharma, E., Dart, R., Gecse, K.B., Mawdsley, J., Anderson, S.H., Ray, S., Irving, P., and Samaan, M.A. (2024, January 12\u201315). Prognostic value of the vedolizumab Crohn\u2019s disease clinical decision support tool in a real-world cohort. Proceedings of the United European Gastroenterology Week, Vienna, Austria."}],"container-title":["Pharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/1\/15\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T11:36:28Z","timestamp":1766489788000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/1\/15"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,22]]},"references-count":14,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["pharmaceutics18010015"],"URL":"https:\/\/doi.org\/10.3390\/pharmaceutics18010015","relation":{},"ISSN":["1999-4923"],"issn-type":[{"value":"1999-4923","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,22]]}}}