Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors Journal Article
| Authors: | Magahis, P. T.; Corso, T.; Livingstone, P.; Tom, E.; Srivastava, A.; Postow, M.; Faleck, D. |
| Article Title: | Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors |
| Abstract: | BACKGROUND: Limited data exist for management strategies targeting immunotherapy-related enteritis (irEnteritis). Systemic corticosteroids are commonly used but often are limited by adverse events. Enteric corticosteroids such as budesonide offer an attractive alternative; however, the ileocolonic release of enteric-coated budesonide has limited utility for diffuse enteritis. Open-capsule budesonide (OCB) is a novel therapeutic approach that offers drug delivery throughout the small bowel. We report outcomes in patients treated with OCB for confirmed or suspected irEnteritis. METHODS: This retrospective cohort included all individuals treated with OCB for irEnteritis at Memorial Sloan Kettering from July 2018 to August 2023. Primary outcomes included clinical response, clinical remission, and corticosteroid-free remission following OCB. Secondary outcomes were OCB-related adverse events and efficacy by gastrointestinal toxicity location. RESULTS: 19 patients (53% female) with irEnteritis were treated with OCB. All patients presented with diarrhea; 15 (79%) reported anorexia with median 6 kg weight loss. 17 patients (89%) underwent esophagogastroduodenoscopy with biopsies revealing enteritis in all; 8 (42%) had concomitant colitis. 15 (79%) patients were treated previously with systemic corticosteroids: 8 (53%) were corticosteroid-dependent while 7 (47%) demonstrated non-response. 18 patients (95%) achieved clinical response, 15 (79%) attained clinical remission, and 11 (58%) had corticosteroid-free remission. Response to OCB was rapid with improvement noted after a median 4 days. 14 (74%) patients restored their pre-irEnteritis weight by OCB cessation. One mild, self-resolving adverse event was reported. CONCLUSIONS: OCB is a safe and effective therapy for irEnteritis. OCB avoids systemic immunosuppression and successfully achieves clinical response and remission even in patients previously nonresponsive to systemic corticosteroids. Future studies are needed to optimize indications and duration. © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
| Keywords: | adult; aged; middle aged; retrospective studies; retrospective study; immunotherapy; enteritis; drug therapy; immunosuppression; budesonide; steroids; immune checkpoint inhibitor; humans; human; male; female; immune checkpoint inhibitors; immune related adverse event - irae |
| Journal Title: | Journal for ImmunoTherapy of Cancer |
| Volume: | 12 |
| Issue: | 7 |
| ISSN: | 2051-1426 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2024-07-01 |
| Start Page: | e009051 |
| Language: | English |
| DOI: | 10.1136/jitc-2024-009051 |
| PUBMED: | 39032941 |
| PROVIDER: | scopus |
| PMCID: | PMC11261704 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF -- MSK corresponding author is David Faleck -- Source: Scopus |
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