VIDEO: Real-world data confirm Rebyota’s ‘consistent’ efficacy in recurrent C. difficile
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Key takeaways:
- Rebyota was effective in real-world analyses, with results consistent with the PUNCH CD3 trial.
- Rebyota was also effective among patients taking concomitant medications associated with microbiome imbalance.
WASHINGTON — In a Healio video exclusive, Paul Feuerstadt, MD, FACG, AGAF, discusses real-world results for Rebyota as a treatment of recurrent Clostridioides difficile infection, which were presented at Digestive Disease Week.
“Any treatment that could replete the microbiota, replete the Bacteroidetes and Firmicutes, can help break that cycle of recurrence and help patients feel better,” Feuerstadt, assistant clinical professor of medicine at Yale School of Medicine and attending gastroenterologist at PACT Gastroenterology Center, told Healio.
In one abstract, an ad-hoc analysis of the phase 3 PUNCH CD3 open-label trial, Feuerstadt and colleagues investigated the safety and efficacy of Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals) among 483 adult patients with recurrent C. diff infection who were also on concomitant medications associated with potential dysbiosis. Of 290 patients included in a modified intent-to-treat analysis, 122 were on proton pump inhibitors (42.1%), 141 were on statins (48.6%) and 160 were taking psychotropic medications (55.2%).
Results demonstrated treatment success at 8 weeks among 77%, 75.9% and 73.8%, respectively, which was consistent with the overall population (74.6%).
“Despite these medications impacting the microbiota, we saw consistent effects for [Rebyota],” Feuerstadt said. “So, overall in the real world, [Rebyota] works with these concomitant medications.”
In another abstract, real-world analysis of medical records at multiple practices showed that among 46 patients with recurrent C. diff infection who received Rebyota, 73.5% maintained efficacy at 8 weeks, which is consistent with the 70.6% efficacy reported in the PUNCH CD3 trial.
“We see that form fits function from the physiology of the application of [Rebyota] and the other the abstracts show, in the real-world, [Rebyota] works in a consistent way,” Feuerstadt said. “And finally, concomitant medications that impact the microbiota don't have a significant effect on the efficacy of Rebyota.”
References:
- Blount K, et al. Poster Sa1910: Significant and durable microbiome compositional changes and clonal engraftment in a phase 3 trial of fecal microbiota, live-jslm for recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
- Ritter TE, et al. Poster Sa1913: Real-world outcomes of a novel fecal microbiota replacement treatment for the prevention of recurrent Clostridioides difficile infection: A multicenter study. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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Tillotson G, et al. Efficacy and safety of fecal microbiota, live-jslm in participants with recurrent Clostridioides difficile infection receiving concomitant medications. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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