Ferring Pharmaceuticals announced the presentation of two real-world data analyses for REBYOTA at IDWeek 2025. These analyses highlight the effectiveness and safety of REBYOTA in preventing recurrent Clostridioides difficile infection (rCDI) in real-world clinical practice, including its positive impact on patients’ health-related quality of life (HR-QOL).

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REBYOTA is the first and only single-dose fecal microbiota transplant (FMT) approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for C. diff infection.

“Recurrent C. diff infection remains a critical public health issue marked by a vicious cycle of recurrent infections that can significantly diminish a patient’s quality of life for both themselves and the family around them,” said Nicholas W. Van Hise, PharmD, Metro Infectious Disease Consultants. “The findings from these real-world studies are highly encouraging as they support the vital role of a single-dose FDA-approved LBP in the prevention of rCDI. This HR-QOL data underscores the profound impact that halting the cycle of recurrence can have on patients’ daily lives, extending beyond just clinical outcomes.”

In the first analysis (presentation number 352), 75% of patients (n=96/128) aged ≥18 years with rCDI who received REBYOTA in physician offices between February 2023 and March 2025 achieved treatment success (defined as no CDI recurrence) at 8 weeks. Recurrent infection was experienced by 21% (n=27). Importantly, among the 40 patients who completed both baseline and 8-week HR-QOL surveys – using the validated Cdiff32 instrument – the mean and standard deviation (mean ± SD) HR-QOL scores significantly improved from 41.4 ± 17.3 at baseline to 57.5 ± 17.8 at week 8. This 16-point gain exceeds the minimal clinically important difference for the Cdiff32 instrument, indicating clinically meaningful benefit. Improvements were observed across all domains (physical, mental, and social functioning).

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The second abstract (poster number 1017) reported interim results from an ongoing, prospective non-interventional registry of patients receiving REBYOTA for rCDI. The analysis included 76 patients who received REBYOTA within 30 days of completing antibiotics for rCDI and completed 8 weeks of follow-up. The patient cohort was predominantly white (93.4%) and female (76.3%), with a median age of 69 years. Through 8 weeks, 82.9% of patients (63/76; 95% CI, 72.5%-90.6%) experienced treatment success (no CDI recurrence). These interim registry data are limited to short-term follow-up and may be subject to selection bias. Importantly, treatment success was 87.8% (36/41) in the subgroup that received REBYOTA after an antibiotic washout period >72 hours, with subgroup outcomes ranging from 77% to 100%.

There were no new safety signals, and the adverse events profile was consistent with prior clinical trials.

In the study, 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). AEs assessed as related to REBYOTA occurred in 3 patients (3.9%), and there was 1 fatal AE during the study, considered unrelated to REBYOTA.

“These real-world results reinforce REBYOTA’s consistent effectiveness and safety profile, and importantly, highlight its positive impact on patients’ health-related quality of life,” said Raza Ahmed, MD, Senior Director of Medical Affairs, Ferring Pharmaceuticals. “Ferring is committed to generating real-world evidence that supports healthcare providers in making informed decisions for patients battling recurrent C. difficile infection.”

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Source- businesswire