VIDEO: ‘Robust’ data analysis establishes safety of Rebyota for recurrent C. difficile
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Key takeaways:
- Treatment-emergent adverse events occurred in 66.4% of patients who received Rebyota vs. 60.2% on placebo.
- Most adverse events were mild to moderate and most frequently related to preexisting conditions.
In a Healio video exclusive, Lindy Bancke, PharmD, outlines results from the “largest safety evaluation to date” for Rebyota, the first FDA-approved, microbiota-based treatment for prevention of recurrent Clostridioides difficile infection.
“There is a significant patient, health care provider and financial burden to address the continued dysbiosis, or disruption of the gut microbiome, and to reduce the associated risks that come with that,” Bancke, vice president of global clinical operations in the U.S. at Ferring Pharmaceuticals, said. “Rebyota is the first and only single-dose FDA-approved microbiota-based treatment for the prevention of recurrence of C. diff infection in individuals 18 years of age and older following antibiotic treatment.”
Bancke and colleagues evaluated data from three phase 2 trials (PUNCH CD, PUNCH CD2 and PUNCH open-label) and two phase 3 trials (PUNCH CD3 and PUNCH CD3-OLS), which included 978 adults who received at least one dose of Rebyota (fecal microbiota, live-jslm, Ferring Pharmaceuticals) and 83 who received only placebo.
All participants had documented recurrent C. difficile infection and completed standard-of-care antibiotic treatment prior to study enrollment.
Researchers recorded treatment-emergent adverse events (TEAEs) for at least 6 months following the last treatment and, in the PUNCH CD2 and PUNCH open-label trials, through 12 months and 24 months, respectively.
Results from the integrated safety analysis, which were published in Therapeutic Advances in Gastroenterology, showed 66.4% of patients in the treatment group and 60.2% of patients in the placebo group experienced TEAEs.
Bancke noted most adverse events were gastrointestinal in nature and included diarrhea, abdominal pain and nausea, the majority of which occurred in “close proximity to the time of the single-dose treatment.” Adverse events were mostly mild or moderate in severity and most frequently related to preexisting conditions, she said.
Results also showed there were no reported infections linked to Rebyota and few (3%) potentially life-threatening TEAEs.
“For the patients and for the treating physician, it is important to understand the safety profile of Rebyota across a broad patient population seen in clinical practice,” Bancke concluded. “This robust integrated analysis provides further evidence Rebyota is a safe and well-tolerated treatment for patients with recurrent C. diff infection.”
Perspective
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Brian B. Baggott, MD, FACG
Bancke presents compelling evidence for the safety of the newly FDA-approved Rebyota for recurrent C. diff infection. Her data is derived from pooled results of three phase 2 and two phase 3 clinical trials, which encompass nearly 1,000 patients.
Microbiome restorative therapy is an alternative pathway to treat recurrent C. diff infection, which occurs in 25% of patients after their initial infection. Although antibiotics treat current C. diff infection, they perturb the background biome, which is fundamental in preventing spore-generation. This initiates recurrent infection when antibiotics are discontinued.
I agree with the author’s statement: “There is a significant patient, health care provider and financial burden” associated with the cycle of recurrent C. diff infection. This treatment is well-tolerated and a potentially life-changing intervention for those patients stuck in the cycle of recurrent C. diff infection.
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