Sign in Subscribe
Infection

Real-World Evidence Supports REBYOTA's Consistent Effectiveness and Safety in Preventing Recurrent C. Diff Infection

Strategic Insights

— 2 min read

Patients who received REBYOTA, a single-dose fecal microbiota transplant, for recurrent Clostridioides difficile infection (rCDI) exhibited a significant improvement in their health-related quality of life (HR-QOL) and achieved treatment success at an 8-week follow-up. According to two real-world studies presented at IDWeek 2025, 75% of patients who received REBYOTA achieved treatment success, and improvements in HR-QOL scores were observed across all domains.

Key Takeaways:

  • 75% of patients (n=96/128) achieved treatment success at 8 weeks, defined as no CDI recurrence
  • 21% of patients (n=27) experienced recurrent infection
  • Mean HR-QOL scores significantly improved from 41.4 (±17.3) at baseline to 57.5 (±17.8) at week 8, exceeding the minimal clinically important difference
  • Improvements were observed across all domains (physical, mental, and social functioning)
  • The second abstract reported interim results from an ongoing, prospective non-interventional registry of patients receiving REBYOTA, with 82.9% of patients (63/76; 95% CI, 72.5%-90.6%) experiencing treatment success
  • Treatment success was 87.8% (36/41) in the subgroup that received REBYOTA after an antibiotic washout period of 72 hours
  • There were no new safety signals, and the adverse events profile was consistent with prior clinical trials

Statistics:

  • 75% of patients achieved treatment success at 8 weeks
  • 21% of patients experienced recurrent infection
  • Mean HR-QOL scores improved by 16 points at 8 weeks (from 41.4 to 57.5)
  • 82.9% of patients experienced treatment success in the registry analysis
  • 87.8% of patients in the subgroup that received REBYOTA after an antibiotic washout period of 72 hours achieved treatment success
  • 18 (23.7%) patients experienced an adverse event (AE), 6 (7.9%) experienced a serious AE, and 1 (1.3%) experienced an AE of special interest (large bowel obstruction)

Sources:

  • Centers for Disease Control and Prevention. About C. diff. Dec. 2024. Available at: https://www.cdc.gov/c-diff/about/index.html
  • Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/clostridioides-difficile-508.pdf?CDC_AAref_Val=https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf
  • Feuerstadt P, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609.
  • Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.

Read more