Efficacy of bezlotoxumab in preventing recurrence of Clostridioides difficile infection: an Italian multicenter cohort study

Objectives: Bezlotoxumab (BEZ) is a promising tool for preventing recurrence of Clostridioides difficile infection (rCDI). The aim of the study was to emulate, in a real-world setting, the MODIFY trials in a cohort of participants with multiple risk factors for rCDI treated with BEZ in addition to standard of care (SoC) vs. SoC alone. Methods: A multicenter cohort study was conducted including 442 patients with CDI from 2018 to 2022 collected from 18 Italian centers. The main outcome was the 30-days occurrence of rCDI. Secondary outcomes were: (i) all-cause mortality at 30 days (ii) composite outcome (30-day recurrence and/or all-cause death). Results: rCDI at day 30 occurred in 54 (12%): 11 in the BEZ+SoC group and 43 treated with SoC alone (8% vs. 14%, OR=0.58, 95%CI:0.31-1.09, p=0.09). The difference between BEZ+SoC vs. SoC was statistically significant after controlling for confounding factors (aOR=0.40, 95%CI:018-0.88, p=0.02) and even more using the composite outcome (aOR=0.35, 95%CI:0.17-0.73, p=0.005). Conclusion: Our study confirms the efficacy of BEZ+SoC for the prevention of rCDI and death in a real-world setting. BEZ should be routinely considered among participants at high risk of rCDI regardless of age, type of CDI therapy (vancomycin vs. fidaxomicin) and number of risk factors.