Matthew Shinkle , 2025-05-05 16:12:00
Key takeaways:
- Ninety-five percent of patients achieved treatment success at 8 weeks after administration of Rebyota via colonoscopy.
- Treatment-emergent adverse events were mostly mild and gastrointestinal in nature.
SAN DIEGO — Administration of Rebyota by colonoscopy appears safe and effective among adults with recurrent Clostridioides difficile infection, according to results from the CDI-SCOPE trial presented at Digestive Disease Week.
Notably, 95% of study participants achieved treatment success at 8 weeks after administration.
Data derived from Khanna S, et al. CDI-Scope: A phase 3b multi-center, single-arm trial exploring the safety and effectiveness of fecal microbiota, live-jslm administered by colonoscopy to adults with recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 3-6; San Diego.
Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) is approved for the prevention of recurrent C. difficile infection (rCDI) among adults following antibiotic treatment, according to study background.
Previous studies have demonstrated the product’s safety and efficacy when administered as a rectal suspension.
“Across five trials and 1,192 patients, the safety is largely there,” presenting author Paul Feuerstadt, MD, FACG, AGAF, associate clinical professor at Yale School of Medicine and attending gastroenterologist at PACT Gastroenterology Center, told Healio. “And two of those trials have 24-month follow-ups — the longest to date with any form of microbiota restoration therapy in a formal trial setting.”
To assess Rebyota’s efficacy and safety in this patient population when administered via colonoscopy, Feuerstadt and colleagues conducted the multicenter, single-arm, phase 3b CDI-SCOPE trial.
Methods, results
Eligible patients had previously been diagnosed with rCDI and completed standard-of-care antibiotic therapy. They underwent a 24- to 72-hour antibiotic washout period prior to bowel preparation and Rebyota administration.
Treatment-emergent adverse events within 8 weeks of administration or treatment failure served as the primary endpoint.
The researchers enrolled 41 patients (mean age, 61.2 years; 88% women, 95% white; mean BMI, 26.34 kg/m2), who had experienced a mean 3.2 rCDI episodes.
Eight weeks after administration via colonoscopy, 39 patients (95%) achieved treatment success. Two patients withdrew consent and did not complete follow-up.
“All 39 of the patients who fulfilled the 8 weeks were cured,” Feuerstadt said. “That really speaks to the efficacy of this product.”
The safety profile was consistent with previous trials, he noted.
Within 8 weeks of administration, the researchers observed five treatment-emergent adverse events, which appeared related to Rebyota, among four patients. All events were mild and gastrointestinal in nature.
Two patients experienced serious treatment-emergent adverse events, neither of which the researchers deemed related to Rebyota or its administration.
Other outcomes
Additional results from the CDI-SCOPE trial showed improvements in health-related quality of life among participants.
Of 30 patients polled, all reported that before treatment, C. difficile recurrence disrupted their sleep and required them to always be near a bathroom. Most (97%) patients said the disease affected their social life and relationships, and 93% indicated it affected their emotional well-being.
Following treatment, 90% of patients noticed symptom improvement within the first month, and 52% reported improvement in the first week.
In addition, most physicians (90%) who performed the colonoscopy procedures reported a “positive” or “very positive” experience with administration, including preparation time and ease of passage through the colonoscope.
“What’s most interesting about it is that the physician experience was good,” Feuerstadt told Healio. “This was a prepackaged set that a provider can open, draw it up into three 50 cc syringes and inject it through the colonoscope during a colonoscopy, similar to what was done previously.”
He added, “This works and it works quite well.”
Reference:
For more information:
Paul Feuerstadt, MD, FACG, AGAF, can be reached at editor@healio.com.
Sources/Disclosures
Collapse
Khanna S, CDI-Scope: A phase 3b multi-center, single-arm trial exploring the safety and effectiveness of fecal microbiota, live-jslm administered by colonoscopy to adults with recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 3-6; San Diego.
Disclosures:
Feuerstadt reports financial relationships with AstraZeneca, Ferring Pharmaceuticals, Nestle Health Science, Probiotech, Regeneron, Sanofi and Vedanta Biosciences. Please see the study for all other authors’ relevant financial disclosures.
