Bezlotoxumab Effective for Preventing Recurrent Clostridioides difficile Infection

Bezlotoxumab, a monoclonal antibody against Clostridioides difficile toxin B, significantly lessened the risk of recurrent C difficile infection (CDI) compared with standard-of-care therapy, according to a meta-analysis published in the Journal of Clinical Gastroenterology.

“Two randomized controlled trials, MODIFY I and II, confirmed bezlotoxumab efficacy in preventing recurrent CDI. However, there are safety concerns about its use in patients with a history of congestive heart failure,” wrote corresponding author Mouhand FH Mohamed, MD, of the Warren Alpert Medical School of Brown University, Providence, Rhode Island, and study coauthors.

The systematic review and meta-analysis included two randomized controlled trials and 11 observational studies assessing bezlotoxumab for preventing recurrent CDI. Some 2337 patients, 1472 of whom received bezlotoxumab, were included in the analysis. 

The pooled rate of recurrent CDI in patients receiving bezlotoxumab was 15.8%, according to the study, compared with 28.9% in patients receiving standard-of-care therapy. A meta-analysis of efficacy found bezlotoxumab significantly reduced the risk of recurrent CDI compared with standard of care; researchers reported a relative risk of 0.57.

Overall mortality and heart failure risk did not differ between bezlotoxumab and standard of care, the study found. Furthermore, 8 out of 9 cost-effectiveness analyses found bezlotoxumab plus standard of care to be more cost-effective than standard of care alone.

“Our meta-analysis comprising real-world data revealed lower recurrent CDI in patients receiving bezlotoxumab and supported its efficacy and safety when added to standard-of-care therapy,” researchers wrote. “The results were consistent across various subgroups. Available cost-effectiveness analyses mostly support bezlotoxumab plus standard of care cost-effectiveness compared with standard of care alone.”

Reference: 
Mohamed MFH, Ward C, Beran A, Abdallah MA, Asemota J, Kelly CR. Efficacy, safety, and cost-effectiveness of bezlotoxumab in preventing recurrent Clostridioides difficile infection: systematic review and meta-analysis. J Clin Gastroenterol. Published online July 3, 2023. doi: 10.1097/MCG.0000000000001875