Timothy Ritter, MD: Real-World Data Supporting Fecal Microbiota for Recurrent C Diff

Initially approved by the US Food and Drug Administration in 2022, live-jslm (Rebyota) is the first microbiome-based therapy for the prevention of recurrence of Clostridioides difficile infection, and new research is providing clinicians with an understanding of its use in real-world patient populations.

Findings from a pair of poster presentations at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, provide real-world data demonstrating live-jslm’s safety and efficacy, building upon previous results from clinical trials.

“In the clinical trials, we had seen very, very few safety issues. Occasionally, you'll see some abdominal cramping or a little bit of leakage with the administration at times, but really there are no significant adverse events with this therapy,” Timothy Ritter, MD, senior medical research director at GI Alliance, explained to HCPLive, going on to describe real-world data as being “crucial” for understanding the drug’s use in clinical practice and not just in select patients in clinical trials.

The first poster examined a cohort of 67 patients with rCDI who received live-jslm and found no adverse events reported with its administration as well as an overall 8-week treatment success rate of 77.6%. Additionally, althoughlthough not statistically significant, those with ≤1 recurrence of CDI had treatment success of 84.2%. Of 30 patients with 6-month follow-up, 26 (86.7%) maintained a sustained response. Investigators also noted there were no recurrences in patients with inflammatory bowel disease at 8 weeks and at 6 months.¹

The second poster examined a cohort of 108 patients with ≥ 8 weeks of follow-up who reported CDI recurrence status at week 8. Most patients (79.6%) had ≥ 3 prior CDI recurrences, 21.3% had received gastric acid suppressants, 5.6% had received fecal microbiota transplantation previously, and 10.2% had received bezlotoxumab. Investigators pointed out nearly all patients (94.4%) received live-jslm between 24-72 hours after antibiotic treatment and 75.0% received live-jslm at home, with an overall treatment success rate of 83.3%, including 82.4% in live-jslm-naïve; 100% in previously live-jslm-treated; 100% in patients with unknown live-jslm history.²

“I think it's just a matter of accumulating more data over time, more use, and then hopefully this will be used more and more to keep patients out of the hospital and from having to deal with this,” Ritter said. “It's a terrible disease, so the more we can keep patients from having recurrences, the better quality of life [they’ll have].”

Editors’ note: Ritter has relevant disclosures with AbbVie, Ardelyx, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Ferring, and others.

References

1. ^{Ritter T, Rosenberg JA, Hengel RL, et al. P2570 - Real World Experience With Microbiota Treatment for the Prevention of Recurrent Clostridioides difficile Infection. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}
2. ^{Khanna S, Goldenberg D, Seo S, et al. P2588 - Characteristics and Real-World Outcomes of Patients Treated With Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent Clostridioides difficile Infection (rCDI). Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}