PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals today announced two poster presentations at the American College of Gastroenterology’s (ACG) 2023 Annual Scientific Meeting for REBYOTA® (fecal microbiota, live – jslm), the first and only single-dose microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
Correlation Between Microbiome Composition and Health-Related Quality of Life (HRQL)
In this post hoc analysis, investigators compared the gut microbiome profile between patient groups with different levels of HRQL using data from PUNCH™ CD3 (poster number P222), the pivotal Phase 3 clinical trial for REBYOTA. Data from the C. difficile Quality of Life Survey (Cdiff32) — which examines the physical, mental and social health of patients with C. diff infection — and from counts of gut microbiome organisms were collected at patient visits at baseline and weeks 1, 4 and 8 of PUNCH CD3. Microbiota data from all visits were divided into four equal groups, or quartiles, based on Cdiff32 score and the average microbiome profile was compared between quartiles. Patients were categorized as improved if Cdiff32 scores improved 10 points or more from baseline to week 8. If not, they were categorized as unchanged. The average microbiome profiles were then compared between baseline and week 8 within the improved and unchanged groups, respectively.
The analysis found that the quartile with the highest Cdiff32 score showed a significantly different microbiome composition from most other groups with lower scores. Patients in the improved group had a healthier microbiome at week 8 versus baseline with higher relative abundances of beneficial gut microbiota (Bacteroidia and Clostridia) and lower amounts of other bacteria (Gammaproteobacteria and Bacilli), suggesting a correlation between gut microbiome composition and HRQL in patients with recurrent C. diff infection.
“As research around the connection between overall health and the gut microbiome continues, it is vital for healthcare providers to consider that when a recurrent C. difficile infection patient enters their practice, their symptoms may go beyond the gut,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine. “These data may help explain why improvement in patient well-being is observed after treatment with live biotherapeutic products, such as REBYOTA.”
Efficacy and Safety of REBYOTA in Older Recurrent C. diff Infection Patients With Common Comorbidities
An ad hoc subgroup analysis evaluated outcomes of older participants with underlying comorbidities — including cardiac, renal and gastrointestinal (GI) disorders — from the PUNCH CD3-Open-Label Study (OLS), an ongoing Phase 3 REBYOTA trial (poster number P0181).
In the modified intent-to-treat population, 43% (172 of 402) of participants were 65 years of age or older, and of the 172 participants, 50% had cardiac disorders (including atrial fibrillation, coronary artery disease and congestive heart failure),16% had renal disorders (including chronic kidney disease, end-stage renal disease and renal failure) and 53% had GI disorders (including gastroesophageal reflux disease, irritable bowel syndrome and inflammatory bowel disease). Treatment success was defined as remaining recurrence-free for eight weeks following treatment with REBYOTA, which was achieved by 63% for those with cardiac disorders, 63% for those with renal disorders and 70% for those with GI disorders.
Participants were also monitored for recurrence and treatment-emergent adverse events (TEAEs) up to six months after treatment. In the safety population, TEAEs were reported by 73% (63 of 86), 70% (19 of 27) and 65% (60 of 92) of older participants with cardiac, renal and GI disorders, respectively. Most TEAEs were mild or moderate and were deemed to be unrelated to treatment by the treating physician.
“The inclusion of complex patients, specifically older patients, in clinical trials is imperative as advanced age and certain underlying illnesses may make them more vulnerable to recurrent C. difficile infection,” said Dr. Feuerstadt. “Seeing efficacy and safety consistent with previous clinical trials of REBYOTA among these higher-risk patients is encouraging.”
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. REBYOTA is approved and marketed in the U.S. only.
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.
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About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, uro-oncology and in specialty areas within gastroenterology, including microbiome therapeutics, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464) or visit http://www.ferringusa.com/.
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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.
