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Published on: December 8, 2014
Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in
Olga C Aroniadis1, Beth Guthmueller2, Kaitlin Dehlin2
1Division of Gastroenterology and Hepatology, Renaissance School of Medicine, Stony Brook University, 101 Nicolls Road HSC T17-060, Stony Brook, NY, 11794-8173, USA. olga.aroniadis@stonybrookmedicine.edu.
Introduction:
The safety and efficacy of microbiota-based products in patients with irritable bowel syndrome (IBS) and recurrent Clostridioides difficile infection (rCDI) has not been studied. Fecal microbiota, live-jslm (RBL; REBYOTA®) is an FDA-approved, single-dose, microbiota-based product to prevent rCDI in adults following standard-of-care (SOC) antibiotic treatment. This was an exploratory subgroup analysis of PUNCH CD3-OLS, a phase 3, open-label, prospective study conducted in the United States (US) and Canada, to evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.
Methods:
Participants aged ≥ 18 years with a diagnosis of rCDI and who completed SOC antibiotic treatment were enrolled in this study. The primary endpoint of PUNCH CD3-OLS was the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs). Secondary endpoints included treatment success at 8 weeks and sustained clinical response at 6 months. In this subgroup analysis, ongoing IBS was confirmed based on medical record documentation at the time of RBL administration.
Results:
Among the 697 RBL recipients, 90 had comorbid IBS. After RBL administration, 52 participants with IBS (57.8%) and 278 participants without IBS (45.8%) experienced TEAEs through 8 weeks. Most TEAEs were mild (22.2% with IBS, 20.1% without IBS) or moderate (26.7% with IBS, 18.8% without IBS). Serious TEAEs were reported by 1 participant with IBS (pneumonia reported to be unrelated to RBL) and 26 participants without IBS [most of which were related to preexisting conditions (3.1%)]. Among all participants, 68.9% with IBS and 75.6% without IBS had absence of CDI diarrhea through 8 weeks after RBL administration. Of the participants with treatment success, 82.3% with IBS and 92.2% without IBS had sustained clinical response through 6 months.
Conclusion:
RBL is a safe and efficacious option to prevent CDI recurrence in patients with concurrent IBS.
Trial Registration:
ClinicalTrials.gov identifier, NCT03931941.
Insights
Fecal microbiota, live-jslm (RBL) is safe and effective for preventing recurrent C. difficile infection (rCDI) in patients with irritable bowel syndrome (IBS). This study shows RBL is a viable treatment option for this patient population.
Area of Science:
- Gastroenterology
- Microbiome Therapeutics
- Infectious Diseases
Background:
- The safety and efficacy of microbiota-based products for patients with irritable bowel syndrome (IBS) and recurrent Clostridioides difficile infection (rCDI) remain understudied.
- Fecal microbiota, live-jslm (RBL; REBYOTA®) is an FDA-approved, single-dose microbiota product indicated for preventing rCDI in adults post-antibiotic treatment.
- This study focuses on an exploratory subgroup analysis of the PUNCH CD3-OLS trial (NCT03931941).
Purpose of the Study:
- To evaluate the safety and efficacy of RBL in participants with documented rCDI and concurrent IBS.
- To assess treatment-emergent adverse events (TEAEs) and clinical outcomes in this specific patient subgroup.
Main Methods:
- An exploratory subgroup analysis of the phase 3, open-label, prospective PUNCH CD3-OLS study.
- Participants aged ≥18 years with rCDI who completed standard-of-care antibiotic treatment were included.
- IBS diagnosis was confirmed via medical record documentation at the time of RBL administration.
Main Results:
- Among 90 participants with IBS, 57.8% experienced TEAEs compared to 45.8% without IBS; most were mild to moderate.
- Absence of CDI diarrhea through 8 weeks was observed in 68.9% of participants with IBS and 75.6% without IBS.
- Sustained clinical response at 6 months was achieved by 82.3% of participants with IBS and 92.2% without IBS.
Conclusions:
- Fecal microbiota, live-jslm (RBL) demonstrates a favorable safety profile in patients with concurrent IBS and rCDI.
- RBL is efficacious in preventing CDI recurrence and achieving sustained clinical response in this patient subgroup.
- RBL represents a safe and effective therapeutic option for patients with rCDI and comorbid IBS.
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