PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals today announced the presentation of two data analyses at IDWeek 2024 evaluating the efficacy and safety of REBYOTA® (fecal microbiota, live – jslm) administered in a real-world setting. REBYOTA is the first and only single-dose microbiome-based therapy 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.
The first analysis (presentation number P-1058) included 73 adults with recurrent C. diff infection (CDI), who received REBYOTA either at home or in a clinic from a healthcare professional affiliated with a home-care provider network between July 2023 and March 2024. Participants were required to have at least 8 weeks of follow-up after REBYOTA administration. CDI recurrence status was assessed at week 8. Most patients (83.6%) received REBYOTA at home and the study included patients who received REBYOTA for the first time (RBL-naïve), as well as those who received additional treatment (previously RBL-treated). The overall treatment success rate (no CDI recurrence at Week 8) was 87.7% (87.3% [62/71] in RBL-naïve; 100% [2/2] in previously RBL-treated).
Participants had a median age of 63.0 years and were mostly female (68.5%). Nearly three-quarters of patients (74.0%) had at least 3 prior CDI recurrences. One third of patients (32.9%) had previously been hospitalized and 38.4% had prior emergency room visits due to CDI (38.4%). Most patients were previously treated with antibiotics for rCDI, including 39.7% with vancomycin only, 11.0% with fidaxomicin only, and 43.8% with both vancomycin and fidaxomicin. All patients, except for 4 with missing data, received REBYOTA 24 to 72 hours following antibiotics.
In the second analysis (poster number P-220), 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 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," said Timothy Ritter, M.D., GI Alliance, Southland, Tex.
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.
About C. diff infection
C. diff infection is a serious and potentially deadly infection that impacts people across the globe. The C. diff bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).1 C. diff infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.2,3 It has been estimated that up to 35% of C. diff infection cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.4,5,6,7 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.6,7 Antibiotics – the current standard of care for treatment of C. diff infection – treat the disease but can also be a contributing factor to the cycle of recurrence.1
About REBYOTA
REBYOTA 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 one visit.
INDICATION
REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
Limitation of Use
REBYOTA is not indicated for the treatment of C. diff infection.
IMPORTANT SAFETY INFORMATION
- You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components.
- You should report to your doctor any infection you think you may have acquired after administration.
- REBYOTA may contain food allergens.
- Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
- REBYOTA has not been studied in patients below 18 years of age.
- Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.
Please click to see the full Prescribing Information.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.
For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X (Twitter).
About IDWeek
IDWeek is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society and the Society of Infectious Diseases Pharmacists. IDWeek is a recognized forum for peer-reviewed presentations of new research on scientific advances and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. For more information, visit www.idweek.org
References:
- Centers for Disease Control and Prevention. What is C. diff? 7 Sep. 2022. Available at: https://www.cdc.gov/cdiff/what-is.html.
- Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: 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.
- Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. 2021 Jul;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11.
- Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
- Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
