Harvard Medical School, Cleveland Clinic Foundation Boston, MA, United States
Jessica El Halabi, MD, MBI1, Natha P. Palmer, PhD2, Kathe Fox, PhD2, Isaac Kohane, MD, PhD2, Maha R. Farhat, MD, MSc2 1Harvard Medical School, Cleveland Clinic Foundation, Boston, MA; 2Harvard Medical School, Boston, MA
Introduction: Clostridioides difficile infection (CDI) continues to be a major health problem in United States, and the rise in the incidence of recurrent CDI remains of particular concern. Furthermore, the treatment landscape of CDI is changing with the recent adoption of fecal microbiota transplantation (FMT); however, national surveys of CDI and its treatment outcomes are challenged by the limited coverage of surveillance data and the limited use of FMT. The aim of this study is to assess the geographic and temporal trends of CDI and evaluate the safety and efficacy of FMT compared to the standard therapy on CDI recurrences.
Methods: We repurposed an administrative database of a private national managed care plan containing medical and prescription drug claims of over 50 million individuals spanning the years 2008-2019 to build a retrospective observational cohort of patients with and without CDI. We used International Classification of Disease (ICD) and prescription data to identify patients with CDI. We estimated trends over time in disease burden and FMT use and further evaluated complications up to 2 years after FMT using a phenome-wide association approach. We also assessed the effect of FMT on the risk for CDI recurrence using a multivariable-adjusted logistic regression.
Results: We identified 38,396 patients with CDI, with a median age of 60 years and among which 60% were females. The rate of CDI increased from 33.4 to 69.46 cases per 100,000 person-years between 2008-2015 but stabilized from 2015-2019. Of the 7,715 patients who had recurrent CDI, 407 patients (5%) underwent FMT. The most common adverse events one month after FMT were gastrointestinal, including abdominal pain, nausea, and vomiting. Sepsis was identified in only two individuals. Complications seen at 6 months, 1 year and 2 years were similar to those identified within 30 days. Moreover, the risk of CDI recurrence significantly decreased post-FMT compared with anti-CDI antibiotics in a multivariable adjusted model (raw-recurrence rate 9.8% vs 36%, aOR = 0.21, 95% CI: [0.12–0.53], p< 0.001).
Discussion: Using real-world healthcare data from a large US private national managed care plan, we show that FMT is strongly associated with a decrease in CDI recurrence compared with the standard care with tolerable complications up to 2 years.
Disclosures: Jessica El Halabi indicated no relevant financial relationships. Natha Palmer indicated no relevant financial relationships. Kathe Fox indicated no relevant financial relationships. Isaac Kohane indicated no relevant financial relationships. Maha Farhat indicated no relevant financial relationships.
Jessica El Halabi, MD, MBI1, Natha P. Palmer, PhD2, Kathe Fox, PhD2, Isaac Kohane, MD, PhD2, Maha R. Farhat, MD, MSc2. P1172 - Fecal Microbiota Transplantation and Clostridioides difficile Infection Among Privately Insured Patients in the United States, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.