Bezlotoxumab Effective for Treating Recurrent Clostridioides difficile Infection

Clostridium difficile
Clostridium difficile
Bezlotoxumab, both alone and in combination with actoxumab, was effective in preventing recurrent Clostridioides difficile infection without increased risk for adverse events.

Severe recurrent Clostridioides difficile infection (rCDI) can be safely and effectively treated with bezlotoxumab plus actoxumab or bezlotoxumab monotherapy, according to meta-analysis results published in the Journal of Clinical Gastroenterology.

To assess the 2 available monoclonal antibodies bezlotoxumab (designed against toxin B) and actoxumab (designed against toxin A), researchers from the University of Chicago in Illinois performed a systematic review of randomized controlled trials of the 2 monoclonal antibodies. A total of 4 trials compared the antitoxin antibodies (n=1916) to placebo (n=889).

The investigators reported that rCDI was significantly reduced with b plus actoxumab dual therapy (risk ratio [RR], 0.54; 95% CI, 0.41-0.70; P <.001). When bezlotoxumab was prescribed as monotherapy, was significantly reduced to a similar extent (RR, 0.62; 95% CI, 0.51-0.76; P <.001). Actoxumab was not observed to be effective monotherapy (RR, 0.94; 95% CI, 0.72-1.22; P =.64).

Bezlotoxumab and actoxumab dual therapy was reported to be preventive in the high-risk patient population, specifically in inpatients (RR, 0.62; 95% CI, 0.48-0.79; P <.001), patients who had vancomycin treatment for a previous CDI (RR, 0.53; 95% CI, 0.40-0.69; P <.001), or patients with a BI/NAP/027 infection (RR, 0.33; 95% CI, 0.18-0.61; P <.001). However, the dual therapy treatment was reported to be less effective in outpatients (RR, 0.20; 95% CI, 0.017-2.41; P =.21), patients on a metronidazole regimen (RR, 0.44; 95% CI, 0.18-1.09; P =.076), or patients with more than 1 previous CDI infection (RR, 0.40; 95% CI, 0.15-1.07; P =.068).

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The study investigators reported no significant difference in cardiovascular problems, gastrointestinal events, or all-cause mortality between patients in the monoclonal antibody treatment groups compared with the placebo groups.

A study limitation is that the total number of randomized clinical trials was low, so any underlying bias in the trials would greatly skew the observations.

The study investigators concluded that bezlotoxumab monotherapy was an effective and safe treatment option in patients with a severe rCDI infection, but not in milder cases.

Disclosure: Atsushi Sakuraba, MD, PhD, has received lecture fees from Takeda Pharmaceutical.

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Akiyama S, Yamada A, Komaki Y, Komaki F, Micic D, Sakuraba A. Efficacy and safety of monoclonal antibodies against Clostridioides difficile toxins for prevention of recurrent Clostridioides difficile infection: a systemic review and meta-analysis [published online February 12, 2020]. J Clin Gastroenterol. doi:10.1097/MCG.0000000000001330

This article originally appeared on Gastroenterology Advisor