Bezlotoxumab Lowered C Difficile Recurrence

Using bezlotoxumab lowers the rate of recurrent Clostridium difficile infection more than a placebo alone, according to results of 2 phase 3 trials published this week in the New England Journal of Medicine.

Using bezlotoxumab lowers the rate of recurrent Clostridium difficile infection more than a placebo alone, according to results of 2 phase 3 trials published this week in the New England Journal of Medicine.

The double-blind, randomized, placebo-controlled trials included data from 2655 adults receiving standard-of-care oral antibiotics for C difficile infection.

Patients were randomly assigned an infusion of bezlotoxumab, which was approved in October 2016 by the FDA. Other study participants were assigned bezlotoxumab with actoxumab or a placebo. Results showed that rates of sustained cure were 64% with bezlotoxumab alone, 58% with bezlotoxumab plus actoxumab, and 54% with a placebo. Actoxumab was not effective when administered alone, and provided no additional benefit alongside bezlotoxumab, according to the researchers.

C difficile is associated with high rates of recurrent infection, which are more difficult to treat and lead to more severe outcomes. Bezlotoxumab’s risk and cost will need to be evaluated in comparison to other treatment options, such as fidaxomicin, which is already known to reduce infection relapse rates, according to the researchers.

Reference

Wilcox MH, Gerding DN, Poxton IR, et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. New Eng J Med. 2017; 376:305-317. doi: 10.1056/NEJMoa1602615.