Real World Study of Recurrent Clostridioides difficile Therapy Demonstrates Efficacy, Safety
At this week’s ID Week, Ferring Pharmaceuticals shares results from its outpatient study examining its treatment, Rebyota, for the prevention of recurrence.
At this week’s ID Week 2024, Ferring Pharmaceuticals announced results of its outpatient real-world study using their Clostridioides difficile (C diff) therapy, Rebyota (fecal microbiota, live – jslm). This study reports the effectiveness of this therapy in this setting.
Rebyota is a live biotherapeutic product (LBP) that is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes, including Bacteroides. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in 1 visit.
Recurrent C diff is an ongoing challenge for clinicians and their patients. Some patients can see frequent recurrences, which can lead to a debilitating quality of life, and in some cases, death.
What the Study Showed
Data included patient demographics, comorbidities, rCDI history, risk factors and treatments, including standard of care antibiotic (SoC). Recurrence, defined as any occurrence of diarrhea with 3 liquid bowl movements or more within 24 hours, was assessed at 8 weeks post-RBL administration.
In the analysis, investigators reviewed the medical records of 64 adult patients from 32 physician offices nationally who received Rebyota from February 2023 to March 2024. In total, 59 patients completed the 8-week follow-up period, of which 75% (n=44) had no CDI recurrence. There were no adverse events reported with treatment aside from minor leakage during administration in 4 patients (6.2%).
“These analyses add to the growing body of real-world evidence demonstrating the efficacy and safety of REBYOTA in clinical or home care settings,"study investigator Timothy Ritter, MD, GI Alliance, Southland, Texas, said in a statement.
Participants in the analysis had a median age of 75 years and were predominantly female (65.6%). Patients had multiple comorbidities (Charlson score 4.5) and 59.4% had 2 or more rCDI risk factors, the most common being age, 65 years or older (75%), and concurrent use of gastric acid suppressants (59.4%). The median number of prior CDI episodes was 3. Fidaxomicin (57.8%) was the most utilized standard-of-care antibiotic for treatment of CDI prior to REBYOTA administration.
Rebyota was FDA approved in November 2022, and indicated for the prevention of recurrence of C diff infection (rCDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
