Bezlotoxumab Could Significantly Reduce Recurrence of C difficile

A recent study found that bezlotoxumab was effective at reducing recurrent Clostridium difficile infections in patients.

The researchers conducted 2 double-blind, randomized, placebo-controlled, phacse 3 trials, MODIFY I and MODIFY II, involving 2655 adults on oral standard-of-care antibiotics for primary or recurrent C difficile infection.
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Patients received either an infusion of bezlotoxumab, actoxumab and bezlotoxumab, or placebo. Researchers measured recurrent infection within 12 weeks after receiving treatment.

For both trials, recurrent C difficile infection was significantly lower in patients on bezlotoxumab than patients taking placebo. In MODIFY I, 17% of patients had a recurrent infection while on bezlotoxumab compared to 28% in the placebo group. In MODIFY II, 16% of patients had a recurrent infection while on bezlotoxumab compared to 26% in the placebo group.

Combined actoxumab and bezlotoxumab was associated with significantly lower recurrence of C difficile in patients compared with placebo. Recurrence of C difficile for patients on combined actoxumab and bezlotoxumab was 16% in MODIFY I and 15% in MODIFY II, compared with 28% in MODIFY I and 26% in MODIFY II placebo groups.

“The rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; the rates of sustained cure (initial clinical cure without recurrent infection in 12 weeks) were 64%, 58%, and 54%, respectively,” the researchers wrote.

Adverse events were similar in each group, with diarrhea and nausea reported the most in patients.

“In prespecified subgroup analyses (combined data set), rates of recurrent infection were lower in both groups that received bezlotoxumab than in the placebo group in subpopulations at high risk for recurrent infection or for an adverse outcome,” the researchers stated.

Researchers noted, however, that the addition of actoxumab did not improve the efficacy of bezlotoxumab.

Overall, bezlotoxumab lowered the rate of recurring C difficile infections in patients, and had a similar safety profile as the placebo.

—Melissa Weiss

Reference:

Wilcox MH, Gerding DN, Poxton IR, et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection [published online January 26, 2017]. The New England Journal of Medicine. doi:10.1056/NEJMoa1602615.