VIDEO: ‘We can feel confident’ in Rebyota for recurrent C. difficile in high-risk patients
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CHICAGO — In a Healio video exclusive, Glenn S. Tillotson, MSc, PhD, discusses the safety and sustained efficacy of Rebyota at 6 months for recurrent Clostridioides difficile infection in patients with immunocompromising conditions.
“One thing we need to remember about this population is that they are often on antibiotics for other infections and conditions that suppress their immune responses,” Tillotson, a partner at GST Micro and consultant microbiologist, said. “The repeat courses of antibiotics that [patients] receive lead to a condition known as dysbiosis ... that is when organisms like Clostridium difficile come to the surface and cause recurrent disease.”
Tillotson and colleagues reported the efficacy and safety of Rebyota (fecal microbiota, live-jslm/RBX2660, Ferring Pharmaceuticals) from an ad hoc analysis of immunocompromised individuals in the ongoing, open-label, phase 3 PUNCH-CD3 study. Results were presented at Digestive Disease Week.
Of 483 study participants with recurrent C. difficile infection, 91 (18.8%) had an immunocompromising condition, primarily due to medication use. The majority had malignant tumors; other conditions included end-stage renal disease and immunodeficiency syndromes.
According to Tillotson, RBX2660 response rates were similar for patients with immunocompromising conditions and without (79% vs. 73.5%, respectively).
“That is reassuring,” he said. “You have patients with tumors, with transplants and on immunocompromising medications, and the response is not in any way reduced with those conditions.”
Tillotson also noted that treatment-emergent adverse events were similar between groups — nearly 65% in those with immunocompromising conditions vs. 62% in those without — and most were mild to moderate and related to C. difficile infection or an underlying condition. Serious treatment-emergent adverse events were observed in 19.8% of patients with immunocompromising conditions and in 8.4% without, with recurrent C. difficile infection the most frequently reported.
Additionally, results showed sustained clinical response through 6 months in 80% of RBX2660 responders with immunocompromising conditions and in 85% of those without.
“Rebyota demonstrated that it is a safe and effective medication in preventing recurrency of C. difficile, especially in comparison to those patients who are without immunocompromising conditions,” Tillotson said. “In those patients who are at an elevated risk, we can feel confident that we are providing them with a good, reliable and effective medication. At this point, with almost 100 patients treated, it is safe.”
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Dubberke ER, et al. Abstract 700: Safety and efficacy of RBX2660 in reducing recurrent Clostridioides difficile infection in immunocompromised patients. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
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