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

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

doi:10.1177/17562848241239547

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

Therap Adv Gastroenterol. 2024 Mar 24:17:17562848241239547. doi: 10.1177/17562848241239547. eCollection 2024.

Authors

Whitfield L Knapple¹, David S Yoho², Alexander Sheh³, Joan Thul⁴, Paul Feuerstadt^{5

6}

Affiliations

¹ Arkansas Gastroenterology, 3401 Springhill Drive #400, North Little Rock, AR 72117, USA.
² Mid-Atlantic Permanente Medical Group, Springfield, VA, USA.
³ Rebiotix, Inc., a Ferring Company, Roseville, MN, USA.
⁴ Ferring Pharmaceuticals, Inc., Parsippany, NJ, USA.
⁵ Yale University School of Medicine, New Haven, CT, USA.
⁶ PACT Gastroenterology Center, Hamden, CT, USA.

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.

Keywords: CDI; Clostridioides difficile; colonoscopy; dysbiosis; live biotherapeutic product; microbiome restoration; microbiome-based therapeutic; microbiota-based therapeutic; rCDI.