Timothy Ritter, MD, senior medical research director, GI Alliance, Southland, Texas, has been involved in both clinical trials and real-world experience utilizing Rebyota (fecal microbiota, live – jslm) for recurrent Clostridioides difficile (C diff) therapy in his practice.
“We have found that from a safety standpoint, which is always the first thing on patients mind, it really was remarkably safe,” Ritter said. We would get a little bit of abdominal cramping and occasional diarrhea. We’d occasionally see a little bit of leakage, but really no significant safety issues with the product at all.”
“From an efficacy standpoint, recurrent Clostridioides difficile infection is a real problem, and we know that up to 35% of patients who get the first infection, we’ll get a second round. And if once you have your second round, the recurrence rates just go up from there. And so in both of the real world evidence posters that are at ID week this week, we see that the use of rebounder had decreased the recurrence rate down to around 14% or 15% so it does a remarkable job of decreasing recurrence.”
At last week’s ID Week 2024, Ferring Pharmaceuticals announced results of its outpatient real-world study. In the analysis, investigators reviewed the medical records of 64 adult patients from 32 physician offices nationally who received Rebyota from February 2023 to March 2024. In total, 59 patients completed the 8-week follow-up period, of which 75% (n=44) had no CDI recurrence. There were no adverse events reported with treatment aside from minor leakage during administration in 4 patients (6.2%).
Data included patient demographics, comorbidities, rCDI history, risk factors and treatments, including standard of care antibiotic (SoC). Recurrence, defined as any occurrence of diarrhea with 3 liquid bowl movements or more within 24 hours, was assessed at 8 weeks post-RBL administration.
“For years, we have just treated these patients with repeated courses of vancomycin and fidoxamycin with all kinds of different strategies about tapering and pulse dosing for over long periods of time with variable effectiveness,” Ritter said. “And now we’ve got a way to directly intervene and prevent the long term use of costly antibiotics, and, more importantly, a way to prevent the basic debilitating symptoms that come with recurrent episodes of C diff.”
