Open-capsule budesonide for the treatment of immune-related enteritis from checkpoint inhibitors.

Autor:	Magahis PT; Weill Cornell Medical College, New York, New York, USA., Corso T; Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Livingstone P; Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Tom E; Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Srivastava A; Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Postow M; Weill Cornell Medical College, New York, New York, USA.; Melanoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Faleck D; Weill Cornell Medical College, New York, New York, USA faleckd@mskcc.org.; Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Jazyk:	angličtina
Zdroj:	Journal for immunotherapy of cancer [J Immunother Cancer] 2024 Jul 20; Vol. 12 (7). Date of Electronic Publication: 2024 Jul 20.
DOI:	10.1136/jitc-2024-009051
Abstrakt:	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. Competing Interests: Competing interests: MP has received consulting fees from BMS, Merck, Novartis, Eisai, Pfizer, and Chugai; and institutional support from RGenix, Infinity, BMS, Merck, and Novartis. DF has received consulting fees from AzurRx, Equillium, Gilead, Janssen, Mallinckrodt Pharmaceuticals, OnQuality Pharmaceuticals and Teva. All other authors have no disclosures. (© 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.)
Databáze:	MEDLINE
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