2436. Real-world Evidence of Fecal Microbiota Transplant Use and Outcomes in Patients with Clostridioides difficile Infection

Abstract

Abstract Background Clostridioides difficile infection (CDI) and recurrent CDI (rCDI) are associated with substantial economic burden, quality-of-life impairment, and increased morbidity and mortality. Fecal microbiota transplant (FMT) is an investigational, non-antibiotic approach to attempt to prevent recurrences in patients with multiple CDI. In controlled trials, efficacy rates of 62–76% have been reported with a single FMT, and up to 90% with multiple FMTs. This study evaluated real-world outcomes in patients with CDI, most of whom had a single FMT. Methods Data from the Optum® de-identified Integrated Claims-Clinical dataset were extracted for patients with a first-observed CDI diagnosis between 4/2011 and 3/2018 that occurred within ±7 days of initial CDI antibiotics. Each patient had a > = 4-year look-back period with no CDI claims prior to the index episode. rCDI was defined as a subsequent antibiotic prescription between 7 and 365 days after the prior CDI episode. The proportion of patients with rCDI, use of FMT, and recurrences after FMT were reported. Results Of the 98,895 patients included in the analysis, 71,189 (72.0%) had one CDI episode, 27,706 (28.0%) had > = 1 rCDI, and 10,233 (10.4%) had multiple rCDI. The mean age was 64.2 years (56% > = 65 years), and 61% were female. Medicare was used by 48% of patients, and commercial insurance was used by 32%. A total of 522 (0.5%) patients (mean age, 61.9 years) received a total of 541 FMT procedures. 36% of the FMT procedures occurred after the first observed CDI episode, 22% after the 1st rCDI, and 42% after the second and/or subsequent rCDI episode. Of those who received FMT, 71.4% (n = 373) of patients had no subsequent CDI events by 3/2018. Conclusion As an investigational procedure, only a very small proportion of patients with CDI were identified as undergoing FMT, and the timing of the procedure for some patients may not have aligned with current guidance. This study provides data on real-world efficacy outcomes after a single FMT, with an efficacy rate of 71.4%, which is consistent with rates reported in controlled trials. A small number of patients received more than one FMT procedure, potentially due to treatment failures. Further research is needed to examine potential improvements in efficacy with multiple FMTs. Disclosures All authors: No reported disclosures.