Bezlotoxumab treatment in combination with standard of care (SOC) is safe and efficacious for lowering the risk for recurrent Clostridioides difficile infection (rCDI). Additionally, cost-effectiveness analyses demonstrate that adding bezlotoxumab to SOC is more cost-effective than using SOC alone, according to study results published in the Journal of Clinical Gastroenterology.
Researchers conducted a systematic review and meta-analysis to assess the consistency of bezlotoxumab safety, efficacy, and cost-effectiveness in a real-world setting. For the analysis, the researchers searched 4 databases (PubMed, EMBASE, Cochrane Library, and Google Scholar) for randomized controlled trials and/or observational studies that evaluated the effectiveness of bezlotoxumab in preventing rCDI.
The primary endpoint was rates of rCDI. Recurrent CDI was defined as the recurrence of CDI within a follow-up period of 12 weeks or 90 to 100 days. To meet the criteria for rCDI, a person needed to develop diarrhea with at least 3 episodes within 24 hours that required SOC antibiotic treatment with or without confirmation through microbiological testing. Secondary endpoints included mortality, heart failure risks, and cost-effective analysis.
A total of 2,337 patients across 13 studies, which consisted of 2 RCTs and 11 observational studies were included in the analysis. Of these patients, only 1472 received bezlotoxumab. Among the studies, 5 of them (n=1,734 patients) compared bezlotoxumabto SOC. Additionally, 9 cost-effectiveness analyses were included, of which 8 demonstrated that using bezlotoxumab plus SOC was more cost-effective, compared with SOC alone.
The rate of rCDI was lower in patients who received bezlotoxumab, compared with those who received SOC. Specifically, the pooled rate of rCDI in patients receiving bezlotoxumab was 15.8% (95% CI, 14%-17.8%), while it was 28.9% (95% CI, 24%-34.4%) in the SOC group. Bezlotoxumab significantly reduced the risk for rCDI compared with SOC (relative risk [RR], 0.57; 95% CI, 0.45-0.72).
The analysis found no evidence of increased or decreased mortality associated with the use of bezlotoxumab, either overall or specifically attributed to CDI.
Additionally, there was a tendency for a higher risk for heart failure associated with bezlotoxumab; however, it was not deemed statistically significant.
Study authors concluded, “Future research should explore the effectiveness of combined preventive therapies in preventing rCDI. Data from larger cohorts are essential to better assess BEZ’s [bezlotoxumab’s] safety in the CHF [congestive heart failure] population.”
This article originally appeared on Gastroenterology Advisor
Mohamed MFH, Ward C, Beran A, et al. 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