Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA^®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection.

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC

ACS Applied Electronic Materials Pub Date : 2024-03-24 eCollection Date: 2024-01-01 DOI:10.1177/17562848241239547

Whitfield L Knapple, David S Yoho, Alexander Sheh, Joan Thul, Paul Feuerstadt

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引用次数: 0

Abstract

Background: Fecal microbiota, live-jslm (RBL; REBYOTA^®), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing Clostridioides difficile infection (CDI) recurrence. Alternative routes of administration are of clinical interest.

Objectives: Evaluate the safety and efficacy of RBL administration via colonoscopy.

Design: Retrospective analysis of electronic medical records of participants administered RBL via colonoscopy under FDA enforcement discretion.

Methods: The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.

Results: TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.

Conclusion: Real-world safety and efficacy of RBL administered via colonoscopy were consistent with clinical trials of rectally administered RBL.

Graphical abstract:

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粪便微生物群、活体-jslm (REBYOTA®) 结肠镜检查预防艰难梭菌感染复发的回顾性亚组分析。

背景：粪便微生物群-活体-jslm（RBL；REBYOTA®）是首个获得美国食品和药物管理局（FDA）批准的单剂量、直肠给药、基于微生物群的活体生物治疗产品，用于预防艰难梭菌感染（CDI）复发。其他给药途径也值得临床关注：评估通过结肠镜给药 RBL 的安全性和有效性：设计：对根据 FDA 执法裁量权通过结肠镜给药 RBL 的参与者的电子病历进行回顾性分析：方法：评估出现治疗和/或手术突发不良事件（TEAEs）的参与者人数。对治疗成功率和持续临床反应（分别定义为 8 周和 6 个月内无 CDI 复发）进行了评估：75%的参与者（6/8）出现了TEAEs；大多数TEAEs的严重程度为轻度至中度，没有任何TEAEs是由RBL或其用药引起的。大多数参与者获得了治疗成功（80%；8/10）；75%（6/8）获得了持续临床应答：结论：通过结肠镜给药 RBL 的实际安全性和有效性与直肠给药 RBL 的临床试验一致：

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ACS Applied Electronic Materials Multiple-

CiteScore

7.20

自引率

4.30%

发文量

567