VIDEO: Rebyota safe, effective when given via colonoscopy for recurrent C. difficile
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CHICAGO — In a Healio video exclusive, Paul Feuerstadt, MD, FACG, AGAF, discusses data showing consistent safety and efficacy of Rebyota when administered via colonoscopy for prevention of recurrent Clostridioides difficile infection.
“C. difficile is a major problem for people in the United States; it is the most common health care-associated infection,” Feuerstadt, assistant clinical professor of medicine at the Yale University School of Medicine and attending gastroenterologist at the PACT Gastroenterology Center, said. “If we treat patients with totally correct antimicrobials, up to 35% of them will recur after initial infection. After that, up to 45% and thereafter up to 60%. This is where treatments called microbiota restoration therapies fit in.”
In a retrospective, real-world analysis, Feuerstadt and colleagues included 94 patients with recurrent C. difficile infection, of whom 39 received one dose of Rebyota (fecal microbiota, live-jslm/RBX2660, Ferring Pharmaceuticals), 10 via colonoscopy. The remaining 55 patients received two or three doses via rectal administration.
Studied endpoints included product- and/or procedure-related treatment-emergent adverse events on or the day after administration, C. difficile infection recurrence within 8 weeks after the final RBX2660 dose and sustained clinical response at 6 months.
According to results presented at Digestive Disease Week, 80% of patients who received RBX2660 via colonoscopy achieved treatment success. Of those who reported treatment success at 8 weeks, 75% (6/8) had sustained clinical response at 6 months.
Although there were no treatment-emergent adverse events related to RBX2660 or its administration, 75% of colonoscopy patients reported mild to moderate adverse events, the most common of which were gastrointestinal disorders and infection.
“As we move forward, we have new options for patients that are FDA-approved and that stamp hopefully will widen availability of products like this to be given after standard of care antimicrobial to reduce recurrence,” Feuerstadt said. “This study, looking at 10 patients from a subgroup analysis, really shows exciting data that if providers choose to potentially use Rebyota in an off-label format, it might be successful 8 out of 10 times and it is in fact safe.”
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Feuerstadt P, et al. Abstract Su1866: Retrospective subgroup analysis of RBX2660 administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 6-9, 2023; Chicago (hybrid).
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