{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T02:21:05Z","timestamp":1760235665180,"version":"build-2065373602"},"reference-count":39,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2021,9,20]],"date-time":"2021-09-20T00:00:00Z","timestamp":1632096000000},"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>Infliximab and vedolizumab are effective treatments for inflammatory bowel disease (IBD), although associated with adverse events (AE). While low or non-existent drug levels and positive antidrug antibodies have been associated with therapeutic failure, there is no clear association between higher drug levels and AE. A cross-sectional study consisting of Crohn\u2019s disease (CD) and ulcerative colitis (UC) patients receiving infliximab or vedolizumab at the Sheba Medical Center was performed. Patients completed a questionnaire regarding AEs related to biological therapy. Serum trough levels obtained on the same day were analyzed. Objective measures of outcomes were retrieved from medical records. Questionnaires were completed by infliximab (n = 169) and vedolizumab (n = 88)-treated therapy patients. Higher infliximab levels were only numerically associated with the occurrence of at least one AE (p = 0.08). When excluding fatigue and abdominal pain, higher infliximab levels were statistically associated with the occurrence of at least one AE (p = 0.03). Vedolizumab drug levels &gt; 18 \u03bcg\/mL were also linked with the occurrence of more AEs. No specific association was observed between the increased levels of either infliximab or vedolizumab and specific AEs (neurological symptoms, upper GI symptoms, infectious complications, and musculoskeletal symptoms). As significant AEs are very rare, additional multi-center studies are required.<\/jats:p>","DOI":"10.3390\/jcm10184265","type":"journal-article","created":{"date-parts":[[2021,9,21]],"date-time":"2021-09-21T08:04:23Z","timestamp":1632211463000},"page":"4265","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study"],"prefix":"10.3390","volume":"10","author":[{"given":"Ido","family":"Veisman","sequence":"first","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oranit","family":"Barzilay","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liora","family":"Bruckmayer","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ola","family":"Haj-Natour","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uri","family":"Kopylov","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rami","family":"Eliakim","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shomron","family":"Ben-Horin","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bella","family":"Ungar","sequence":"additional","affiliation":[{"name":"Sheba Medical Center Tel Hashomer, Department of Gastroenterology, Ramat Gan 52620, Israel"},{"name":"Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo 67011, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,9,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1409","DOI":"10.1038\/ajg.2012.218","article-title":"Serious infection and mortality in patients with Crohn\u2019s disease: More than 5 years of follow-up in the TREAT\u2122 registry","volume":"107","author":"Lichtenstein","year":"2012","journal-title":"Am. 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