Abstract
Reports on real-world experience on efficacy of bezlotoxumab (BEZ) has been lacking thus far. We retrospectively studied the efficacy and safety of BEZ in preventing the recurrence of Clostridium difficile infection (CDI) in five university hospitals in Finland. Seventy-three percent of our 46 patients remained free of recurrence in the following 3 months and the performance remained as 71% effective also among immunocompromised patients. In severe CDI, BEZ prevented recurrence in 63% of cases. From our study patients, 78% had three or more known risk factors for recurrence of CDI. Eight of our patients were waiting for fecal microbiota transplantation but after stopping the antibiotics that were continued to prevent recurrence of CDI and after receiving BEZ, all remained free of recurrence and did not need the procedure. Success with BEZ as an adjunctive treatment in preventing recurrence of CDI in high-risk patients may be rated as high. Among a subgroup of our patients, those already evaluated to be in need of fecal microbiota transplantation, BEZ seems to be an alternative option.
Highlights
Following a primary episode of Clostridium difficile infection (CDI), roughly 25% of patients treated with metronidazole or vancomycin will have a recurrent CDI in subsequent 3 months, most frequently in 2 to 3 weeks after cessation of the initial treatment regimen
Eight of the outpatients were waiting for fecal microbiota transplantation (FMT) after having had several (3 in five, 4 in two, and 2 in one patient) episodes of CDI and estimated to have a high risk of recurrent CDI (rCDI)
One of the outpatients already had received FMT but after having rCDI 3 months later, he was successfully treated with BEZ
Summary
Following a primary episode of Clostridium difficile infection (CDI), roughly 25% of patients treated with metronidazole or vancomycin will have a recurrent CDI (rCDI) in subsequent 3 months, most frequently in 2 to 3 weeks after cessation of the initial treatment regimen. Bezlotoxumab (BEZ) is a fully humanized monoclonal antibody against C. difficile toxin B and indicated for prevention of rCDI in at-risk patients [17, 18]. The efficacy and safety of BEZ were investigated among adults in global trials MODIFY I and MODIFY II in 2011–2015 [19]. In both studies, BEZ significantly reduced (p < 0.001) rCDI and had a favorable safety profile.
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