Introduction
Clostridioides difficile infection (CDI) is the most common cause of healthcare associated infectious diarrhea in hospitalized patients, affecting primarily elderly patients with comorbidities after antibiotic exposure. Despite introduction of novel antibiotic options, recurrent CDI (rCDI) remain a major clinical challenge. Bezlotoxumab, an anti-Toxin B monoclonal antibody used in conjunction with standard of care antibiotic therapy, has been shown to reduce the frequency of rCDI in registration trials. To date, there is limited post-marketing data on this compound concerning its clinical efficacy and safety outside trials. The aim of the BODEGA study was to assess the clinical efficacy, safety and logistics of administration of bezlotoxumab in a real-life setting.
Aims & Methods
In this observational, prospective and retrospective multicenter study, we collected data from 100 patients receiving bezlotoxumab in combination with standard of care for the prevention of rCDI. Follow-up with respect to response and safety was performed at days 10, 45 and 90. For each patient, variables with respect to demography, fitness, previous CDI treatments and CDI associated hospitalizations, diagnostic and outcome were documented. Documentation was performed by use of the online platform ClinicalSurveys.Net. For statistical analysis, SPSS version 29.0.0.0 (241) was used.
Results
At the time of this analysis, data from 88/100 unique patients with documented CDI was evaluable, as 12 had not yet completed follow-up. The evaluable study population consists of 62,5% (n=55) females with an average age of 59 years (range: 20-91). Overall, 94,3% (n=83) of patients presented with additional comorbidities. Gastrointestinal (n=33, 37,5,4%) and cardiovascular diseases (n=38, 43,2%) were most frequently documented. Patients experienced a median of 3 episodes (range=0-10) of CDI prior to the episode in which bezlotoxumab was administered. The most recent CDI episode was non-complicated in 90,9% (n=80) and community acquired in 52,9% (n=46). Patients received fidaxomicin standard (n=36, 40,9%), fidaxomicin extended (n=16, 18,2%), vancomycin standard (n=13, 14,8%), vancomycin tapered (n=13, 14,8%) and others (n=4, 4,5%) as antibiotic treatment for the episode during which bezlotoxumab was administered. In their CDI patient history, most patients received the following treatments sequentially: vancomycin and fidaxomicin (n=34, 38,6%) fidaxomicin only (n=25, 28,4%, multiple administrations possible) and vancomycin only (n=16, 18,2%, multiple administrations possible). In 76/88 patients (86,4%) and 67/83 (76,1%) there was no further recurrence on day 45 and 90, respectively.
Conclusion
Preliminary data from the BODEGA study demonstrates comparatively low recurrence rates at days 45 and 90 in a real-life setting. Our study population was characterized by cases of multiply recurrent CDI with an uncomplicated course of CDI, that was often acquired in an ambulatory care setting. In these aspects, the study population differs significantly from patients included in registration trials. Although follow-up is not yet complete for all study patients, we conclude that bezlotoxumab is a promising option for treating patients with multiply recurrent CDI.
References
N/A
Disclosure
Funded with an unrestricted grant from Merck/MSD
