Background and importance Clostridioides difficile is the most common cause of infectious diarrhoea in hospitalised patients and causes great morbidity due to the high percentage of recurrence. Bezlotoxumab is a monoclonal antibody against toxin B, intended to prevent relapse. Due to its high cost, it is used in a population and under conditions slightly different to those referred to in the MODIFY clinical trials. Due to the scarcity of real-life studies, it is necessary to collect data on the effectiveness of bezlotoxumab in daily hospital practice.
Aim and objectives To determine the effectiveness of bezlotoxumab in preventing recurrences of C. difficile infection (CDI) in patients from a tertiary hospital in Spain.
Material and methods We conducted a longitudinal, retrospective study of a cohort of patients treated with bezlotoxumab between 2 August 2018 and 31 March 2021. All patients received a single infusion of bezlotoxumab at 10 mg/kg. The main variable was the percentage of clinical cure within 12 weeks. As secondary variables, this percentage was analysed in terms of different risk factors.
Results 52 patients were included in the study. The median age was 73.5 years, 32 (61.5%) were women and the median Charlson index was 5.16. ?? (42.9%) patients received bezlotoxumab during the first CDI episode, 22 (30.8%) during the first recurrence and 14 (26.4%) during the second or later recurrences. 32 patients (61.54%) received vancomycin at standard dose during recurrence, 16 (30.77%) used vancomycin tapering and 4 (7.69%) fidaxomicin. There were 9 (18.4%) recurrences within 12 weeks of bezlotoxumab infusion. It should be noted that 6 patients died during the inpatient stay and 3 others did so during the 12 weeks of follow-up, so they were excluded from the calculation of the recurrence ratio. The main risk factor for recurrence identified was severe infection (77.8% of recurrences) followed by age above 65 years and immunosuppression, which were present in 66.7% and 44.4% of the recurrences, respectively.
Conclusion and relevance The recurrence ratio at 3 months of bezlotoxumab administration was 20.9%, which is similar to that found in the pivotal clinical trials (16.5%). The highest prevalence of recurrences was identified in the subgroup of patients with severe CDI.
Conflict of interest No conflict of interest
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