Fecal microbiota, live – jslm Demonstrates Safety, Efficacy in Prevention of Recurrent C difficile Infections

Data presented at the American College of Gastroenterology’s annual meeting show promising potential of fecal microbiota, live–jslm (RBL, Rebyota; Ferring Pharmaceuticals) for the prevention of recurrent clostridioides difficile (C diff) in individuals over the age of 18. According to results from a real-world retrospective analysis, the treatment demonstrated favorable safety and efficacy, as well as improved quality of life for patients.

The real-world analysis of RBL treatment demonstrated significant improvements in infection recurrence. Image Credit: © Best - stock.adobe.com

“Recurrence remains a common threat for people who have C. diff infection, with the risk increasing in older adults and those who have had multiple recurrences. This analysis adds to our growing body of real-world data on the efficacy and safety of [fecal microbiota, live–jslm] observed in a patient population seen in clinical practice every day," said Timothy Ritter, MD, GI Alliance, Southland, Texas.¹

C diff is a spore-forming, potentially fatal bacteria that causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis. There are approximately 500,000 C diff infections (CDI) and 15,000 to 30,000 and related deaths each year in the United States, of which 35% of recovered individuals experience recurrent CDI (rCDI). Following the first recurrence, 65% of patients may develop subsequent recurrence. Continued infections are associated with life-threatening sepsis, which can occur in about 27% to 39% of patients who had an initial episode.^2,3

Standard of care for CDIs is antibiotics; however, they also can contribute to recurring infections. RBL is a microbiota-based live biotherapeutic product formulated as a single-dose 150 mL rectal suspension administered by a health care professional. In clinical study, it was associated with restoration of the intestinal microbiome, increased Bacteroidia and Clostridia and decreased Gammaproteobacteria and Bacilli, as well as a reduction in the number of antibiotic-resistant organisms and antibiotic-resistance genes. RBL is the first FDA-approved therapy indicated for preventing rCDI in adults following SOC antibiotic treatment.^2,4

The real-world analysis of RBL treatment demonstrated significant improvements in infection recurrence, indicating its promise as a subsequent therapeutic option following antibiotics. The real-world setting included the outcomes of 67 adults with rCDI who received RBL between February 2023 and May 2024. Recurrence was defined by occurrence of diarrhea with 3 liquid bowel movements or more within 24 hours at 8 weeks and 6 months following treatment.¹

In the first abstract, at week 8, 77.6% of patients were recurrence free, and 86.7% of 30 patients at the 6 month follow up maintained a sustained response. Patients with inflammatory bowel disease (IBD)had no CDI recurrences at 8 weeks and at 6 months. In the second abstract, 83.3% of patients with rCDI who received RBL had no CDI recurrence, including 82.4% who had not previously received the treatment and 100% of patients who did.¹

The third analysis, researchers interviewed patients who participated in CDI-SCOPE, a multi-center, single-arm phase 3b clinical trial. The interview focused on the burden of recurrent CDI on health-related quality-of life (HRQoL) and any improvements in HRQoL following RBL administration. According to data from 15 patient interviews, RBL treatment resulted in resolved or less severe diarrhea (53.3% and 46.7%, respectively). Additionally, 80% reported that CDI required them to stay close to a bathroom, 80% said it impacted leisure time, 73.3% experienced sleep disruptions, and 73.3% said it affected their diet. After treatment with RBL, participants reported improved physical function, ability to return to leisure activities and time with family, as well as improved mental health.¹

CDI can be a debilitating, chronic infection for many patients with gastrointestinal diseases such as Crohn’s disease or IBD. RBL offers an advanced therapeutic option capable of treating and preventing recurring infections.

REFERENCES

1. Ferring presents new data analyses for rebyota® (fecal microbiota, live – jslm) at acg 2024. Business Wire. October 28, 2024. Accessed November 5, 2024. https://www.businesswire.com/news/home/20241028137492/en

2. Fecal microbiota, live-jslm for the prevention of recurrent c difficile infection. Pharmacy Times. August 1, 2024. Accessed November 5, 2024. https://www.pharmacytimes.com/view/fecal-microbiota-live-jslm-for-the-prevention-of-recurrent-c-difficile-infection

3. About c. diff. CDC. Accessed November 5, 2024. https://www.cdc.gov/c-diff/about/index.html#:~:text=Clostridioides%20difficile%20%5Bklos%E2%80%93TRID%E2%80%93,an%20inflammation%20of%20the%20colon

4. Blair H. Rbx2660 (rebyota®) in preventing recurrence of clostridioides difficile infection: a profile of its use in the usa. Drugs Ther Perspect. September 23, 2023. doi: 10.1007/s40267-023-01023-y