{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T08:29:12Z","timestamp":1740126552880,"version":"3.37.3"},"reference-count":49,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","license":[{"start":{"date-parts":[[2020,8,19]],"date-time":"2020-08-19T00:00:00Z","timestamp":1597795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2020,8,19]],"date-time":"2020-08-19T00:00:00Z","timestamp":1597795200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100007827","name":"American College of Gastroenterology","doi-asserted-by":"publisher","award":["Clinical Research Award Pilot Projects 2016\u20102018"],"award-info":[{"award-number":["Clinical Research Award Pilot Projects 2016\u20102018"]}],"id":[{"id":"10.13039\/100007827","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1 TR001425"],"award-info":[{"award-number":["UL1 TR001425"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver Transpl."],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:p>Despite adverse effects like hyperglycemia, new\u2010onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first\u2010pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity\u2010therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single\u2010center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3\u00a0mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy\u2010proven acute cellular rejection (ACR), NODAT (hemoglobin A1c &gt;6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a01.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid\u2010induced infections and NODAT. Randomized controlled trials are required to validate these findings.<\/jats:p>","DOI":"10.1002\/lt.25837","type":"journal-article","created":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T08:06:10Z","timestamp":1593504370000},"page":"1430-1440","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial"],"prefix":"10.1097","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4346-840X","authenticated-orcid":false,"given":"Khurram","family":"Bari","sequence":"first","affiliation":[{"name":"Division of,Digestive Diseases,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3406-7310","authenticated-orcid":false,"given":"Shimul A.","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of,Endocrinology, Diabetes and Metabolism,Department of Medicine,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tiffany E.","family":"Kaiser","sequence":"additional","affiliation":[{"name":"Division of,Digestive Diseases,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert M.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Transplant Surgery,Department of Surgery,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadeem","family":"Anwar","sequence":"additional","affiliation":[{"name":"Division of,Digestive Diseases,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Kleesattel","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0560-0019","authenticated-orcid":false,"given":"Kenneth E.","family":"Sherman","sequence":"additional","affiliation":[{"name":"Division of,Digestive Diseases,University of Cincinnati,Cincinnati,OH"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2020,8,19]]},"reference":[{"key":"lt25837-bib-0001-20240115","article-title":"A comprehensive review of immunosuppression used for liver transplantation","volume":"2009","year":"2009","journal-title":"J Transplant"},{"key":"lt25837-bib-0002-20240115","doi-asserted-by":"crossref","first-page":"1625","DOI":"10.1097\/01.tp.0000250361.60415.96","article-title":"Negative impact of new\u2010onset diabetes mellitus on patient and graft survival after liver transplantation: long\u2010term follow up","volume":"82","year":"2006","journal-title":"Transplantation"},{"key":"lt25837-bib-0003-20240115","doi-asserted-by":"crossref","first-page":"741","DOI":"10.1080\/00365521.2018.1463390","article-title":"Steroid\u2010free immunosuppression with low\u2010dose tacrolimus is safe and significantly reduces the incidence of new\u2010onset diabetes mellitus following liver transplantation","volume":"53","year":"2018","journal-title":"Scand J Gastroenterol"},{"key":"lt25837-bib-0004-20240115","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1016\/S0041-1345(96)00255-2","article-title":"Early steroid withdrawal in liver transplant patients: final report of a prospective randomized trial","volume":"29","year":"1997","journal-title":"Transplant Proc"},{"key":"lt25837-bib-0005-20240115","doi-asserted-by":"crossref","first-page":"886","DOI":"10.1097\/SLA.0000000000000969","article-title":"Is minimal, [almost] steroid\u2010free immunosuppression a safe approach in adult liver transplantation? 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