Weill Cornell Medical College, New York, New York, USA.
Gastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
J Immunother Cancer. 2024 Jul 20;12(7):e009051. doi: 10.1136/jitc-2024-009051.
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.
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.
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.
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.
针对免疫治疗相关肠炎（irEnteritis）的管理策略数据有限。全身性皮质类固醇类药物通常被广泛使用，但往往受到不良反应的限制。布地奈德等肠内皮质类固醇类药物是一种有吸引力的替代药物；然而，肠包衣布地奈德的回肠-结肠释放对弥漫性肠炎的作用有限。开放胶囊布地奈德（OCB）是一种新的治疗方法，可在整个小肠内提供药物输送。我们报告了在 Memorial Sloan Kettering 接受 OCB 治疗确诊或疑似 irEnteritis 的患者的结果。
本回顾性队列研究纳入了 2018 年 7 月至 2023 年 8 月期间在 Memorial Sloan Kettering 接受 OCB 治疗 irEnteritis 的所有个体。主要结局包括 OCB 治疗后的临床反应、临床缓解和皮质类固醇自由缓解。次要结局是 OCB 相关的不良反应和胃肠道毒性部位的疗效。
19 名（53%为女性）irEnteritis 患者接受了 OCB 治疗。所有患者均出现腹泻；15 名（79%）报告食欲不振，中位数体重减轻 6kg。17 名（89%）患者接受了食管胃十二指肠镜检查和活检，所有患者均发现肠炎；8 名（42%）同时患有结肠炎。15 名（79%）患者此前接受过全身性皮质类固醇治疗：8 名（53%）为皮质类固醇依赖性，7 名（47%）为皮质类固醇无反应。18 名（95%）患者获得临床反应，15 名（79%）达到临床缓解，11 名（58%）实现皮质类固醇自由缓解。OCB 反应迅速，中位数 4 天后观察到改善。14 名（74%）患者通过停止 OCB 恢复了 irEnteritis 前的体重。报告了 1 例轻度、自行缓解的不良事件。
OCB 是治疗 irEnteritis 的一种安全有效的方法。OCB 避免了全身免疫抑制，即使在对全身皮质类固醇无反应的患者中，也能成功实现临床反应和缓解。需要进一步的研究来优化适应症和治疗时间。
