VIDEO: Rebyota ‘not only shuts down recurrence,’ also affects quality of life in C. diff
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VANCOUVER, British Columbia — In this Healio video, Paul Feuerstadt, MD, FACG, AGAF, discusses data that link health-related quality of life and microbiome composition among patients with recurrent Clostridioides difficile infection.
“C. difficile is a major problem in the United States; in fact, it’s estimated that upwards of a half million individuals are diagnosed with this infection on an annual basis,” Feuerstadt, assistant clinical professor of medicine at Yale School of Medicine and attending gastroenterologist at PACT Gastroenterology Center, said. “The biggest challenge with this infection, as most clinicians know, is recurrence.”
He continued, “Up to 35% of patients who are treated completely appropriately for C. difficile will recur, and of those, 45% will go on to recur after that and up to 60% thereafter, as patients get caught in this vicious cycle of recurrence. And those multiple recurrences take their toll on our patients.”
Feuerstadt and colleagues used data from the phase 3 PUNCH-CD3 trial — an ongoing, open-label study examining the safety and efficacy of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) in adults with recurrent C. difficile infection — to investigate the link between microbiome composition and health-related quality of life.
Participants completed a C. difficile-specific quality of life questionnaire (Cdiff32) at baseline and weeks 1, 4 and 8, and researchers used those scores and average microbiota profiles to group patients into quartiles for comparison. They found that the microbiome composition in the highest Cdiff32-score quartile was significantly different than that of lower-scoring groups.
“Essentially, the Cdiff32 varied in correlation with the constituency of the microbiota: Specifically, increases in Bacteroides and Firmicutes helped the Cdiff32 and decreases in the Gammaproteobacteria and Bacilli — the bad bacteria — actually negatively correlated with Cdiff32,” Feuerstadt said. “A treatment like Rebyota not only shuts down recurrence, but actually can have an impact on health-related quality of life.”
Researchers also conducted an analysis of older study participants with at least one comorbidity, including cardiac disorders, chronic kidney disease and gastrointestinal disorders. Rebyota efficacy remained consistent among those with one (68%), two (61%) and three or more (69%) medical comorbidities.
“What’s really important here is the population that we see most frequently with C. difficile, aged over 65 with medical comorbidities, when we look at those groups specifically, Rebyota has a very consistent efficacy and safety profile, consistent with the pivotal phase 3 data applied to a real-world population,” Feuerstadt said. “We really see opening of our eyes to impact of treatments like Rebyota on health-related quality of life and consistency of efficacy in complicated patients.”
Reference:
- Feuerstadt P, et al. Efficacy and safety of fecal microbiota, live-jslm in older participants with recurrent Clostridioides difficile infection and underlying comorbidities: An ad hoc analysis of an open-label, phase 3 study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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Feuerstadt P, et al. Association of microbiome composition and health-related quality of life in patients with recurrent Clostridioides difficile infection: Results from the PUNCH CD3 phase 3, randomized, placebo-controlled clinical trial. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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