702. Efficacy of Fecal Microbiota, Live-jslm After Receipt of Non–Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial
Authors: Reveles Kelly R , Gonzales-Luna Anne J , Golan Yoav , Alonso Carolyn D , Guthmueller Beth , Tan Xing , Bidell Monique , Pokhilko Victoria , Crawford Carl , Skinner Andrew M 
Published: November 2023

Abstract

Background
Live biotherapeutic products (LBPs) are adjunctive therapies to prevent recurrence of Clostridioides difficile infection (CDI). In this post hoc subgroup analysis, the durability of fecal microbiota, live-jslm (REBYOTA™; abbreviated here as RBL, previously known as RBX2660), the first microbiota-based LBP approved by the US Food and Drug Administration for the prevention of recurrent CDI (rCDI) in adults following antibiotic treatment for rCDI, was investigated in a subset of participants who received systemic antibiotics for indications other than CDI following RBL treatment in a phase 2 open-label trial (NCT02589847).

Methods
PUNCH Open Label participants were ≥ 18 years old with either ≥ 2 rCDI episodes treated with standard-of-care antibiotic therapy after a primary CDI episode, or ≥ 2 severe CDI episodes requiring hospitalization. Participants in this analysis all received 2 doses of RBL rectally administered approximately 7 days apart. We report outcomes at various timepoints for participants who were successfully treated with RBL and subsequently received non-CDI systemic antibiotics.

Results
A total of 43 participants were included in the analysis; the mean age was 65.9 years, most were male (67.4%), and most (97.7%) had ≥ 3 rCDI episodes before RBL. Most participants were treated with antibiotic monotherapy (n=34/43, 79.1%), received 1 course of treatment (n=28/43, 65.1%), and did not receive CDI prophylaxis (n=38/43, 88.4%). The median time to antibiotic exposure after the second dose of RBL was 155 days (interquartile range [IQR], 55-349), and the median duration of treatment per antibiotic course was 8 days (IQR, 4.5-12.5). Urinary system infections were the most common indication for antibiotic treatment (n=17/43, 40%). Among evaluable participants who received systemic antibiotics within 8 weeks, 6 months, 12 months, and 24 months of RBL administration, 91.6% (11/12), 95.7% (22/23), 90.6% (29/32), and 83.3% (30/36) remained CDI recurrence-free, respectively. A total of 86% (37/43) of participants were recurrence-free at their last evaluable timepoint.

Conclusion
In this post hoc analysis, RBL remained effective in preventing CDI recurrence in patients with multiple episodes of rCDI after subsequent systemic antibiotic exposure.

Disclosures
Kelly R. Reveles, PharmD, PhD, Ferring Pharmaceuticals: Advisor/Consultant|Ferring Pharmaceuticals: Honoraria Anne J. Gonzales-Luna, PharmD, BCIDP, Cidara Therapeutics: Grant/Research Support|Ferring Pharmaceuticals: Personal Fees|Paratek Pharmaceuticals: Grant/Research Support|Seres Therapeutics: Grant/Research Support Yoav Golan, MD, Ferring Pharmaceuticals: Advisor/Consultant|Pfizer: Honoraria|Seres Therapeutics: Advisor/Consultant|Vedanta Bioscience: Advisor/Consultant Carolyn D. Alonso, MD, Academy for Continued Healthcare Learning: Honoraria|AiCuris: Advisor/Consultant|American Society of Healthcare Pharmacists: Honoraria|Cidara Therapeutics: Advisor/Consultant|Clinical Care Options: Honoraria|Merck: Advisor/Consultant|Merck: Grant/Research Support Beth Guthmueller, AS, Rebiotix Inc., a Ferring Company: Employee Xing Tan, PharmD, Ferring Pharmaceuticals: Employee Monique Bidell, PharmD, Ferring Pharmaceuticals: Employee Victoria Pokhilko, PhD, Ferring Pharmaceuticals: Employee Carl Crawford, MD, Ferring Pharmaceuticals: Advisor/Consultant Andrew M. Skinner, MD, Academy for Continued Healthcare Learning: Honoraria|American Society of Healthcare Pharmacists: Honoraria|Ferring Pharmaceuticals: Honoraria|MJH Life Sciences: Honoraria