Outcomes of Patients Receiving Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection - A Multicenter Study

ABSTRACT

Introduction: Clostridioides difficile infection (CDI) is the most common healthcare-associated infection in the United States (US). Treatment guidelines have evolved resulting in better outcomes however recurrent disease remains a major issue associated with significant morbidity despite best practices. Bezlotoxumab (BEZ) is a fully humanized monoclonal antibody approved by FDA in 2017 for prevention of recurrent CDI (rCDI). Limited real-world data are available regarding BEZ usage outside of clinical trials. In this multicenter study, we aim to report our experience with BEZ at a large healthcare system in northeast US. Method(s) We retrospectively reviewed all consecutive adult patients who received BEZ from 1/2017 until 12/2021 at Yale-New Haven Health System and had at least 90 days of follow up. Data collected for each patient included demographics, medical co-morbidities, adverse events to BEZ and rates of rCDI following BEZ. Result(s) A total of 114 patients were included with a mean age of 67.3 years (range 25-97);74 (64.9%) were female. There has been a recent increased utilization of BEZ with more than half of our sample (n=73, 64%) being since the beginning of COVID-19 pandemic and 38.6% in 2021 alone. Most patients were treated with vancomycin (88.6%) while 11 (9.7%) received fidaxomicin. Median time from most recent CDI episode to BEZ infusion was 22.5 days. Notably, 17.5% were not on active CDI treatment when they received BEZ. 30 (26.3%) received BEZ after initial CDI, 52 (45.6%) had one prior recurrent episode while 32 (28.1%) had 2 or more previous recurrences. Among those who received BEZ, 10 patients (8.8%) experienced 90-day rCDI, of these 9 (90%) had history of at least 1 episode of rCDI. There were no statistically significant differences in baseline characteristics between r-CDI and non-rCDI groups (Table). Furthermore, no statistical difference in rCDI between those who were on CDI treatment at the time of BEZ and those who completed it before BEZ [9/94 (9.6%) vs 1/20 (5.0%);p=0.511]. Conclusion(s) Our real-life data confirms that Bezlotoxumab appears to be safe and effective in preventing rCDI in this population whether given during CDI treatment or after. BEZ represents an important treatment option in this highly morbid population. Further studies are needed to determine the benefit of early administration of BEZ after index CDI in those at risk and to consider utilization shifts following the 2021 ACG updated guideline recommendations advising it's usage.