New real-world evidence presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting supports the use of live-jslm (Rebyota), a microbiome-based therapy, in preventing recurrent Clostridioides difficile infection (rCDI). The data, derived from two poster presentations, builds upon previous clinical trial results, demonstrating the therapy's safety and efficacy in broader patient populations.
Real-World Outcomes of Live-jslm
One poster presentation examined 67 patients with rCDI treated with live-jslm. The study reported a 77.6% overall treatment success rate at 8 weeks, with no adverse events associated with the treatment's administration. Notably, patients with ≤1 recurrence of CDI showed an even higher treatment success rate of 84.2%. Among the 30 patients with 6-month follow-up data, 26 (86.7%) maintained a sustained response. The study also found no recurrences in patients with inflammatory bowel disease at both 8 weeks and 6 months.
The second poster focused on a cohort of 108 patients with ≥8 weeks of follow-up, assessing CDI recurrence status at week 8. The majority (79.6%) had ≥3 prior CDI recurrences, with 21.3% receiving gastric acid suppressants, 5.6% having undergone fecal microbiota transplantation previously, and 10.2% having received bezlotoxumab. The study highlighted that nearly all patients (94.4%) received live-jslm within 24-72 hours after antibiotic treatment, and 75.0% received the treatment at home. The overall treatment success rate was 83.3%, including 82.4% in live-jslm-naïve patients and 100% in previously live-jslm-treated patients.
Expert Commentary
According to Timothy Ritter, MD, senior medical research director at GI Alliance, real-world data is crucial for understanding the drug’s use in clinical practice beyond select clinical trial participants. He noted the scarcity of significant adverse events in clinical trials, with only occasional abdominal cramping or leakage during administration. Ritter emphasized the importance of accumulating more data over time to expand the use of live-jslm, aiming to reduce hospitalizations and improve the quality of life for patients suffering from this "terrible disease."
These findings suggest that live-jslm is a safe and effective option for preventing the recurrence of C. difficile infection in a real-world setting, reinforcing its potential to improve patient outcomes and reduce the burden of this challenging condition.
