Is bezlotoxumab effective in reducing the recurrence of Clostridium difficile (C diff) colitis?

Updated: Jul 25, 2019
  • Author: Faten N Aberra, MD, MSCE; Chief Editor: BS Anand, MD  more...
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In October 2016, the FDA approved bezlotoxumab, a human monoclonal antibody that binds to C difficile toxin B and neutralizes its effects. [59] It is used with standard-of-care antibiotics to reduce the recurrence of CDI in adults who have a high risk of recurrence. Approval was based on the results from the global Monocolonal Antibodies For C Difficile Therapy (MODIFY) I and MODIFY II studies, which showed a single dose of bezlotoxumab (in conjunction with antibiotics) is superior to placebo in prevention of CDI recurrence through 12 weeks (= 0.0003 for both trials). [59, 60]  High risk in these studies was defined as age 65 years and older, recent CDI (within 6 months), prior recurrent CDI, compromised immunity, severe CDI (Zar score >1), or infection with a hypervirulent, binary toxin–positive strain.

In general, management of the first recurrence of CDI is the same as that for the initial episode, including stratification according to disease severity. [5] However, although metronidazole can be used for the first recurrence of CDI (if it is not severe), the drug should not be used for subsequent recurrences or for long-term, chronic therapy (risk of cumulative neurotoxicity). Rather, a second or later recurrences should be managed with vancomycin therapy using a tapered and/or pulse regimen. [5]

The SHEA and IDSA have made no recommendations for preventing recurrent CDI in patients with an underlying infection requiring continued antimicrobial management. [5]

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