P2588 - Characteristics and Real-World Outcomes of Patients Treated With Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent Clostridioides difficile Infection (rCDI)
Sahil Khanna, MBBS, MS1, David Goldenberg, MD2, Sanghyuk Seo, PharmD, MS3, Min Yang, MD, PhD4, Viviana Garcia-Horton, PhD5, Yipeng Gao, PhD6, Hannah Kim, PhD5, Loren Ormenaj, BS5, Amy Guo, PhD3 1Mayo Clinic, Rochester, MN; 2Stanford University School of Medicine, Redwood City, CA; 3Ferring Pharmaceuticals, Inc., Parsippany, NJ; 4Analysis Group, Inc., Boston, MA; 5Analysis Group, Inc., New York, NY; 6Analysis Group, Inc., Boston, NJ
Introduction: Clostridioides difficile infection (CDI) is a bacterial infection with symptoms that can range from diarrhea to life-threatening sepsis. Recurrence of CDI (rCDI) is common, where prior recurrence of CDI is associated with up to 65% risk of subsequent recurrences. Fecal microbiota, live-jslm (RBL) is the first fecal microbiota-based product approved by the FDA for the prevention of rCDI in adult patients following antibiotic treatment. This study reports the characteristics and real-world outcomes of patients with rCDI who received RBL.
Methods: This retrospective cohort study included adults with rCDI who received RBL at home or in a clinic in the US who had at least 8 weeks of follow-up after RBL administration and reported CDI recurrence status at week 8. Patient characteristics, administration setting, prior medication use, and prior healthcare resource utilization were collected. The primary outcome was treatment success, defined as the absence of CDI recurrence within 8 weeks of RBL administration, consistent with the definition used in RBL clinical trials. Continuous variables were summarized using median and interquartile ranges (IQRs) and categorical variables were summarized using counts and percentages.
Results: A total of 108 patients had at least 8-week follow up and reported CDI recurrence status at week 8. The median (IQR) age of patients was 64.5 (47.8, 77.0) years, 72.2% were female, 50.0% had commercial or private insurance, and 47.2% had Medicare. Most patients (79.6%) had ≥ 3 prior CDI recurrences, 21.3% had received gastric acid suppressants, 5.6% had received fecal microbiota transplantation previously, and 10.2% had received bezlotoxumab (Table). One third of patients (32.4%) had previously been hospitalized and 36.1% of patients had prior emergency room visits due to CDI. Most patients had received prior antibiotics for rCDI: 36.1% with vancomycin only, 8.3% with fidaxomicin only, 49.1% with both vancomycin and fidaxomicin, and 0.9% with vancomycin, fidaxomicin, and metronidazole. Almost all patients (94.4%) received RBL between 24-72 hours after antibiotic treatment and 75.0% received RBL at home. The overall treatment success rate was 83.3% (82.4% [84/102] in RBL-naïve; 100% [2/2] in previously RBL-treated; 100% [4/4] in patients with unknown RBL history).
Discussion: This study demonstrated that RBL is effective in preventing rCDI through week 8 in real-world practice, including in a home care setting.
Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
David Goldenberg: Ferring Pharmaceuticals, Inc. – Consultant.
Sanghyuk Seo: Ferring Pharmaceuticals, Inc. – Employee.
Min Yang: Analysis Group, Inc (has received consulting fees from Ferring for the conduct of the study) – Employee.
Viviana Garcia-Horton: Analysis Group, Inc (has received consulting fees from Ferring for the conduct of the study) – Employee.
Yipeng Gao: Analysis Group, Inc (has received consulting fees from Ferring for the conduct of the study) – Employee.
Hannah Kim: Analysis Group, Inc (has received consulting fees from Ferring for the conduct of the study) – Employee.
Loren Ormenaj: Analysis Group, Inc (has received consulting fees from Ferring for the conduct of the study) – Employee.
Amy Guo: Ferring Pharmaceuticals, Inc. – Employee.
Sahil Khanna, MBBS, MS1, David Goldenberg, MD2, Sanghyuk Seo, PharmD, MS3, Min Yang, MD, PhD4, Viviana Garcia-Horton, PhD5, Yipeng Gao, PhD6, Hannah Kim, PhD5, Loren Ormenaj, BS5, Amy Guo, PhD3. P2588 - Characteristics and Real-World Outcomes of Patients Treated With Fecal Microbiota, Live-jslm (RBL) for the Prevention of Recurrent <i>Clostridioides difficile</i> Infection (rCDI), ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
