P-1020. Real-World Effectiveness and Health-Related Quality of Life Improvements Using Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection

TL;DR

This study shows that a microbiota-based treatment effectively prevents recurring Clostridioides difficile infection and improves patients' quality of life in real-world settings.

Contribution

The study provides real-world evidence of the effectiveness and quality-of-life benefits of fecal microbiota treatment for recurrent CDI.

Findings

75% of patients had treatment success at 8 weeks with RBL.

Health-related quality of life scores improved significantly from baseline to 8 weeks.

RBL was safe and effective in routine clinical practice for preventing CDI recurrence.

Abstract

Fecal microbiota, live-jslm (RBL) is a microbiota-based product approved for the prevention of recurrence of Clostridioides difficile infection (rCDI) in adults following antibiotic treatment and was demonstrated to be safe and efficacious in clinical trials. Recurrence of CDI is frequent and has been shown to negatively impact health-related quality of life (HR-QOL). This study reports the effectiveness of RBL and assessment of HR-QOL in an outpatient real-world setting.Table 1.Study Cohort Demographics and Treatment CharacteristicsFigure 1.Treatment Outcomes (N=128)

Study Cohort Demographics and Treatment Characteristics

Treatment Outcomes (N=128)

This single-arm, multicenter study included patients ≥18 years with rCDI who received RBL in physician offices from February 2023 to March 2025. Data included patient demographics, comorbidities, rCDI history, risk factors, RBL therapy characteristics, standard of care antibiotic (SoC), other related treatments and RBL-related adverse events. Recurrence, defined as 3 or more occurrences of diarrhea within 24 hours, was assessed at 8 weeks post-RBL administration. HR-QOL was assessed at baseline and at 8 weeks with the Cdiff32, a validated, disease-specific patient-reported instrument to evaluate changes in HR-QOL associated with CDI.Figure 2.Health-Related Quality of Life over Time with the Cdiff32 Survey1 (n=40)

Health-Related Quality of Life over Time with the Cdiff32 Survey1 (n=40)

RBL was administered to 128 patients. Patient characteristics are shown in Table 1. Patients had a median age of 71 (IQR: 62-80) years and were predominantly female (71.9%). Patients had multiple comorbidities (Charlson score 4; IQR: 3-6) and 42.2% had 2 or more rCDI risk factors. The most common risk factors were age ≥65 years (69.5%) and concurrent gastric acid suppressant use (43.0%). The median number of prior CDI episodes was 3 (IQR: 1-3). Overall, 75% had treatment success at 8 weeks, 21% had a recurrence and 4% were lost to follow-up (Figure 1). A total of 40 patients completed both baseline and 8-week HR-QOL surveys. Mean±SD HR-QOL improved from baseline (41.4±17.3) to week 8 (57.5±17.8). Improvements in scores were seen in all domains from baseline to week 8 (Figure 2).

This real-world study demonstrated that RBL treatment to prevent recurrence of CDI was safe and effective in routine clinical practice, with clinically meaningful improvements observed in HR-QOL between baseline and 8-weeks.

Richard L. Hengel, MD, FIDSA, Gilead: Grant/Research Support Timothy E. Ritter, MD, Abbvie: Advisor/Consultant|Boehringer Ingelheim: Advisor/Consultant|Bristol Myers Squibb/Celgene: Advisor/Consultant|Eli Lilly: Advisor/Consultant|Ferring: Advisor/Consultant|Genentech/Roche: Advisor/Consultant|Gilead: Advisor/Consultant|Intercept: Advisor/Consultant|Iterative Health: Advisor/Consultant|Janssen: Advisor/Consultant|Merck: Advisor/Consultant|Pfizer: Advisor/Consultant|Sanofi: Advisor/Consultant|Spyre Therapeutics: Advisor/Consultant|Takeda: Advisor/Consultant Jonathan A. Rosenberg, MD, Aimmune: Advisor/Consultant|Ferring Pharmaceuticals: Advisor/Consultant Lucinda J. Van Anglen, PharmD, FIDSA, Cumberland Pharmaceuticals: Grant/Research Support|Ferring Pharmaceuticals: Grant/Research Support|Melinta Therapeutics: Grant/Research Support|Novartis: Grant/Research Support|Takeda Pharmaceuticals: Grant/Research Support Mielad Moosapanah, PharmD, Ferring Pharmaceuticals: Employee Sanghyuk Seo, PharmD, Ferring Pharmaceuticals: Employee Kevin W. Garey, PharmD, MS, FIDSA, FASHP, Acurx: Grant/Research Support|Merck & Co.: Grant/Research Support|Paratek Pharmaceuticals: Grant/Research Support

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