Reviewing Real-World Safety and Efficacy Data on C difficile Therapy Rebyota

Fecal microbiota, live-jslm (Rebyota [RBL]), which is indicated for treatment of recurrent C difficile, has been FDA approved for over 2 years now, and with it comes real-world efficacy and safety data.

Paul Feuerstadt, MD, FACG, AGAF, associate clinical professor of Medicine at Yale School of Medicine, has been involved with studies around this therapy for several years, and believes the product is very safe and effective.

He provides details about an abstract presented at the Digestive Disease Week conference that looked at 5 prospective trials, including 2 randomized control trials and multiple open label studies. “It was an integrated safety analysis of those trials, including 11,192 individuals who received at least of 1 dose of RBL, 676 who received 1 dose of RBL, and 83 who received placebo. And then in effect, showed that there was consistency of adverse events between the placebo and those who received RBL, and that consistency shows that RBL doesn't leave patients at greater risk for adverse events and serious adverse events,” Feuerstadt said. “Serious adverse events were 11.2% for a single dose of RBL, and 7.2% for a single dose of placebo.”

Additionally some of the trial participants had comorbidities such as inflammatory bowel disease (IBD) and mild to moderate immunocompromised states. Specifically, Feuerstadt describes the results of an open label study which included 71 participants who had IBD.

“The efficacy was 78.9% at 8 weeks within that population; with an 80% efficacy in those with Crohn's disease and a 76.2% efficacy in those with ulcerative colitis. So, it was very consistent with the phase 3 data as well as the overall open label group,” he said.

For those with an immunocompromised state, Feuerstadt says this population performed well with efficacy, which was 75.7% at 8 weeks, and 88.7% remained responsive. 

“Paramount to all this is safety, and the safety profiles were consistent, regardless of immune compromised state or inflammatory bowel disease,” Feuerstadt said. “Now, when we contextualize this with guidelines—the American Gastroenterological Association in February of 2024—said that we should be considering microbiota restoration in FDA approved products in the immune competent, but for the immune compromised, they said there was insufficient data."

However, he points to new data in a phase 3 open label study of 140 individuals who were mild to moderately immune compromised, which he says, proves Rebyota is a safe therapy for this population.