{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T21:17:57Z","timestamp":1778102277736,"version":"3.51.4"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T00:00:00Z","timestamp":1737331200000},"content-version":"vor","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Oncology at Vanderbilt University Medical Center"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,1,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Immune checkpoint inhibitors (ICIs) have advanced the treatment of metastatic melanoma. However, some patients develop ICI-associated toxicities like hepatitis (ie, immune-mediated hepatitis; IMH). Although these toxicities usually resolve with steroids, steroid-refractory events may occur, which may be a major source of morbidity and mortality without obviously defined treatment algorithms. Herein, we present 2 patients with metastatic melanoma who had IMH that was steroid-refractory and only partially mycophenolate-responsive, but fully resolved with budesonide. The case suggests that budesonide is a potential option to treat IMH that is refractory to standard treatments, but further investigation in a larger series is needed to identify the most optimal setting for budesonide use.<\/jats:p>","DOI":"10.1093\/oncolo\/oyae361","type":"journal-article","created":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T15:24:52Z","timestamp":1737386692000},"source":"Crossref","is-referenced-by-count":8,"title":["Steroid-refractory immune mediated hepatitis managed with budesonide in patients with metastatic melanoma: proof of concept and literature review"],"prefix":"10.1093","volume":"30","author":[{"given":"Roma A","family":"Kankaria","sequence":"first","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine, Vanderbilt University School of Medicine , Nashville, TN 37232 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas B","family":"Johnson","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine, Vanderbilt University Medical Center , Nashville, TN 37232 ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,1,20]]},"reference":[{"key":"2025031509013221000_CIT0001","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1200\/JCO.21.02229","article-title":"Long-term outcomes with nivolumab plus ipilimumab or nivolumab alone versus ipilimumab in patients with advanced melanoma","volume":"40","author":"Wolchok","year":"2022","journal-title":"J Clin Oncol."},{"key":"2025031509013221000_CIT0002","doi-asserted-by":"publisher","first-page":"1714","DOI":"10.1200\/JCO.2017.77.6385","article-title":"Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline","volume":"36","author":"Brahmer","year":"2018","journal-title":"J Clin Oncol"},{"key":"2025031509013221000_CIT0003","doi-asserted-by":"publisher","first-page":"e002435","DOI":"10.1136\/jitc-2021-002435","article-title":"Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events","volume":"9","author":"Brahmer","year":"2021","journal-title":"J ImmunoTher Cancer"},{"key":"2025031509013221000_CIT0004","doi-asserted-by":"publisher","first-page":"1875639","DOI":"10.1080\/2162402X.2021.1875639","article-title":"A multicenter characterization of hepatitis associated with immune checkpoint inhibitors","volume":"10","author":"Patrinely","year":"2021","journal-title":"Oncoimmunology"},{"key":"2025031509013221000_CIT0005","doi-asserted-by":"publisher","first-page":"1384","DOI":"10.1053\/j.gastro.2020.08.063","article-title":"AGA clinical practice update on diagnosis and management of immune checkpoint inhibitor colitis and hepatitis: expert review","volume":"160","author":"Dougan","year":"2021","journal-title":"Gastroenterology"},{"key":"2025031509013221000_CIT0006","doi-asserted-by":"publisher","first-page":"671","DOI":"10.1002\/hep.31065","article-title":"Diagnosis and management of autoimmune hepatitis in adults and children: 2019 Practice Guidance and Guidelines From the American Association for the Study of Liver Diseases","volume":"72","author":"Mack","year":"2020","journal-title":"Hepatology"},{"key":"2025031509013221000_CIT0007","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1111\/bcp.13456","article-title":"Comparative safety of systemic and low-bioavailability steroids in inflammatory bowel disease: systematic review and network meta-analysis","volume":"84","author":"Bonovas","year":"2018","journal-title":"Br J Clin Pharmacol"},{"key":"2025031509013221000_CIT0008","doi-asserted-by":"publisher","first-page":"39","DOI":"10.2147\/CEG.S34715","article-title":"Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis","volume":"7","author":"Iborra","year":"2014","journal-title":"Clin Exp Gastroenterol"},{"key":"2025031509013221000_CIT0009","doi-asserted-by":"publisher","first-page":"5993","DOI":"10.1158\/1078-0432.CCR-21-1283","article-title":"Early use of high-dose glucocorticoid for the management of irAE is associated with poorer survival in patients with advanced melanoma treated with Anti-PD-1 monotherapy","volume":"27","author":"Bai","year":"2021","journal-title":"Clin Cancer Res."},{"key":"2025031509013221000_CIT0010","doi-asserted-by":"publisher","first-page":"3706","DOI":"10.1002\/cncr.31629","article-title":"High-dose glucocorticoids for the treatment of ipilimumab-induced hypophysitis is associated with reduced survival in patients with melanoma","volume":"124","author":"Faje","year":"2018","journal-title":"Cancer"},{"key":"2025031509013221000_CIT0011","doi-asserted-by":"publisher","first-page":"168","DOI":"10.1016\/j.ejca.2021.04.045","article-title":"Hyperacute toxicity with combination ipilimumab and anti-PD1 immunotherapy","volume":"153","author":"Dearden","year":"2021","journal-title":"Eur J Cancer."},{"key":"2025031509013221000_CIT0012","doi-asserted-by":"publisher","first-page":"2580","DOI":"10.1158\/1078-0432.CCR-22-3181","article-title":"Corticosteroids and cancer immunotherapy","volume":"29","author":"Goodman","year":"2023","journal-title":"Clin Cancer Res."},{"key":"2025031509013221000_CIT0013","doi-asserted-by":"publisher","first-page":"e29473","DOI":"10.1097\/MD.0000000000029473","article-title":"Immune-checkpoint inhibitor-associated grade 3 hepatotoxicity managed with enteric-coated budesonide monotherapy: a case report","volume":"101","author":"Eleftheriotis","year":"2022","journal-title":"Medicine (Baltim)."},{"key":"2025031509013221000_CIT0014","doi-asserted-by":"publisher","first-page":"657","DOI":"10.1016\/j.jhep.2016.11.015","article-title":"Managing immune checkpoint-inhibitor-induced severe autoimmune-like hepatitis by liver-directed topical steroids","volume":"66","author":"Ziemer","year":"2017","journal-title":"J Hepatol."},{"key":"2025031509013221000_CIT0015","doi-asserted-by":"publisher","first-page":"e009051","DOI":"10.1136\/jitc-2024-009051","article-title":"Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors","volume":"12","author":"Magahis","year":"2024","journal-title":"J ImmunoTher Cancer."},{"key":"2025031509013221000_CIT0016","doi-asserted-by":"publisher","first-page":"100719","DOI":"10.1016\/j.jhepr.2023.100719","article-title":"Clinical pattern of checkpoint inhibitor-induced liver injury in a multicentre cohort","volume":"5","author":"Hountondji","year":"2023","journal-title":"JHEP Rep"},{"key":"2025031509013221000_CIT0017","doi-asserted-by":"publisher","first-page":"1716","DOI":"10.1007\/s10637-021-01136-z","article-title":"Comparison of clinical features between immune-related sclerosing cholangitis and hepatitis","volume":"39","author":"Takinami","year":"2021","journal-title":"Invest New Drugs."},{"key":"2025031509013221000_CIT0018","doi-asserted-by":"publisher","first-page":"1711","DOI":"10.1001\/jamaoncol.2021.4342","article-title":"Utility of liver biopsy in diagnosis and management of high-grade immune checkpoint inhibitor hepatitis in patients with cancer","volume":"7","author":"Li","year":"2021","journal-title":"JAMA Oncol"},{"key":"2025031509013221000_CIT0019","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1001\/jamaoncol.2021.4318","article-title":"Management of cutaneous immune-related adverse events in patients with cancer treated with immune checkpoint inhibitors: a systematic review","volume":"8","author":"Nadelmann","year":"2022","journal-title":"JAMA Oncol"},{"key":"2025031509013221000_CIT0020","doi-asserted-by":"publisher","first-page":"1919","DOI":"10.3390\/cancers16101919","article-title":"Outcomes of budesonide as a treatment option for immune checkpoint inhibitor-related colitis in patients with cancer","volume":"16","author":"Machado","year":"2024","journal-title":"Cancers (Basel)"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/30\/1\/oyae361\/61519139\/oyae361.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/30\/1\/oyae361\/61519139\/oyae361.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,15]],"date-time":"2025-03-15T09:01:55Z","timestamp":1742029315000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/doi\/10.1093\/oncolo\/oyae361\/7964588"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1,17]]}},"URL":"https:\/\/doi.org\/10.1093\/oncolo\/oyae361","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,1]]},"published":{"date-parts":[[2025,1]]},"article-number":"oyae361"}}