{"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":1792051255195,"version":"4.4.0"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T00:00:00Z","timestamp":1706140800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. pediatr. gastroenterol. nutr."],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Therapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure\u2013response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52\u2010week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12\u2010month clinical outcomes were recorded. For this study, we defined therapeutic target levels (&gt;20\u2009\u03bcg\/mL at Week 6 and &gt;12\u2009\u03bcg\/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty\u2010nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]\/indeterminate colitis [IC]) were included in the study. In total, 68% (40\/59) of patients had vedolizumab levels at Week 6\u00a0and 90% (53\/59) had levels drawn at Week 6 or 14. Thirty\u2010five percent of Week 6 trough levels were below our defined target of 20\u2009\u03bcg\/mL. Fifty\u2010two of 59 patients had available data at 52 weeks. Over 80% (42\/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23\/29], UC\/IC 83% [19\/23]). Sixty\u2010two percent (26\/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of &lt;8 weeks. Thirty\u2010one of these 42 (74%) were in clinical remission (CR)\u00a0rate at 52 weeks with 29\/42 (69%) in corticosteroid\u2010free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31\/52).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Proactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jpn3.12132","type":"journal-article","created":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T13:02:09Z","timestamp":1706187729000},"page":"853-861","source":"Crossref","is-referenced-by-count":12,"title":["Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease"],"prefix":"10.1002","volume":"78","author":[{"given":"Patrick","family":"Rowland","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"McNicol","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Department of Pharmacy Nationwide Children's Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Kiel","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross M.","family":"Maltz","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Donegan","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer L.","family":"Dotson","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Department of Pharmacy Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Center for Child Health Equity and Outcomes Research Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilary K.","family":"Michel","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Department of Pharmacy Nationwide Children's Hospital Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendan","family":"Boyle","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1,25]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215734"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215739"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2016.02.016"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14167"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2018.02.013"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12887-022-03229-x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/crocol\/otab039"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjx082"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000003389"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izz131"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izaa102"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjz018"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15484"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izy272"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2018.04.040"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/2050640619840211"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2017.11.050"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000002833"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(22)00307-7"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.20867"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1536-4801.1991.tb10268.x"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-017-0546-0"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000002051"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.227"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000001029"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2016.11.023"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000000533"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.22673.1"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/PG9.0000000000000276"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjz041"}],"container-title":["Journal 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