Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA®), for the Prevention of Recurrent Clostridioides difficile Infection in Participants With Inflammatory Bowel Disease in PUNCH CD3-OLS.
Jessica R Allegretti, Paul Feuerstadt, Whitfield L Knapple, Robert Orenstein, Philippe Pinton, Alexander Sheh, Sahil Khanna
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引用次数: 0
Abstract
Background: Fecal microbiota, live-jslm (RBL; REBYOTA®), is the first single-dose, broad consortia, microbiota-based live biotherapeutic approved by the US Food and Drug Administration to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Inflammatory bowel disease (IBD) is a common risk factor for rCDI, yet patients with IBD are often excluded from prospective trials. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated the safety and efficacy of RBL in participants with rCDI and IBD.
Methods: Participants with IBD (ulcerative colitis [UC], Crohn's disease [CD], or unspecified) who had rCDI were included. Treatment-emergent adverse event (TEAE) data were collected for up to 6 months following RBL administration. Efficacy outcomes included treatment success at 8 weeks and sustained clinical response at 6 months.
Results: Overall, 793 participants were enrolled, and 697 received RBL; 74 had IBD (UC: n = 45; CD: n = 25; unspecified IBD: n = 4). TEAEs within 8 weeks of administration were reported by 45.9% and 47.5% of participants with and without IBD, respectively; most were mild or moderate gastrointestinal symptoms. Serious TEAEs within 8 weeks of administration were reported by 1.4% and 4.2% of participants with and without IBD, respectively. The treatment success rate at 8 weeks was 78.9%, and the sustained clinical response rate at 6 months was 91.1% in participants with IBD, similar to rates in participants without IBD (73.2% and 91.0%, respectively).
Conclusions: The results of this subgroup analysis of PUNCH CD3-OLS suggest RBL is safe and efficacious in patients with IBD.
背景：粪便微生物群；REBYOTA®)是美国食品和药物管理局（fda）批准的首个单剂量、广泛联合、基于微生物群的活生物治疗药物，用于预防标准护理抗菌素治疗后成人复发性艰难梭菌感染（rCDI）。炎症性肠病（IBD）是rCDI的常见危险因素，但IBD患者通常被排除在前瞻性试验之外。PUNCH CD3-OLS （NCT03931941）的亚组分析评估了RBL在rCDI和IBD患者中的安全性和有效性。方法：纳入了患有IBD（溃疡性结肠炎[UC]，克罗恩病[CD]或未指明）且患有rCDI的参与者。治疗中出现的不良事件（TEAE）数据在RBL给药后的6个月内收集。疗效结果包括8周治疗成功和6个月持续临床反应。结果：共纳入793名受试者，697名接受RBL治疗；74例IBD (UC: n = 45；CD: n = 25；未指定IBD: n = 4)。在有IBD和没有IBD的参与者中，分别有45.9%和47.5%的人报告了8周内的teae；大多数为轻度或中度胃肠道症状。有IBD和无IBD的受试者中分别有1.4%和4.2%报告了8周内严重teae。8周时的治疗成功率为78.9%，6个月时IBD患者的持续临床缓解率为91.1%，与非IBD患者相似（分别为73.2%和91.0%）。结论：PUNCH CD3-OLS的亚组分析结果表明，RBL治疗IBD患者是安全有效的。
期刊介绍：
Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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