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. 2025 Jun 21:18:17562848251346593.
doi: 10.1177/17562848251346593. eCollection 2025.

Real-world use of bezlotoxumab to prevent recurrent Clostridioides difficile infections: a single-center experience and meta-analysis

Kanika Sehgal  1   2 , Parul Berry  3 , Raseen Tariq  1   4 , Darrell S Pardi  1 , Sahil Khanna  5
Affiliations

Real-world use of bezlotoxumab to prevent recurrent Clostridioides difficile infections: a single-center experience and meta-analysis

Kanika Sehgal et al. Therap Adv Gastroenterol. .

Abstract

Background: Clostridioides difficile infection (CDI) treated with bezlotoxumab (BEZ) has been demonstrated to have a lower recurrence rate than placebo in clinical trials. However, real-world data on BEZ's effectiveness remain limited and heterogeneous.

Objectives: To evaluate the real-world effectiveness of BEZ in preventing CDI recurrence through a single-center retrospective cohort and a meta-analysis.

Design: A retrospective cohort study and a meta-analysis.

Methods: A retrospective study of patients treated with BEZ from 2017 to 2021 was performed at the Mayo Clinic. Demographics, CDI diagnostics, and several prespecified risk factors were analyzed. A literature search was conducted in August 2024 utilizing the Cochrane Central Register of Controlled Trials, Embase, Medline, Scopus, and Web of Science Core Collection. Studies reporting CDI resolution rates with BEZ were included. The random-effects model described by DerSimonian and Laird was used to calculate weighted pooled resolution rates (WPR) with 95% confidence intervals (CI). We assessed heterogeneity with the inconsistency index (I 2) statistic.

Results: Across 28 studies and our retrospective cohort, 2639 CDI patients were analyzed. Among 1786 patients treated with BEZ, 1450 achieved clinical resolution (WPR: 81.6%, 95% CI 77.2-85.6%), with significant heterogeneity (I² = 77.3%). In subgroup analysis, the pooled relative risk of recurrence was 0.56 (95% CI 0.36-0.88; p < 0.01) for BEZ with SoC compared to SoC alone. A WPR of 83.3% (95% CI 75.5%-91.1%) for patients receiving BEZ with SoC was observed when compared with a WPR of 70.8% (95% CI 62.7%-78.8%) in patients receiving SoC alone on subgroup analysis. In our cohort of 47 patients, the CDI resolution rate was 72.3% (34/47).

Conclusion: Our retrospective study and meta-analysis demonstrate the real-world efficacy of BEZ in reducing CDI recurrence. The higher recurrence rates in our cohort likely reflect the high-risk nature of the population, including a greater proportion of immunocompromised patients.

Keywords: CDI; Clostridioides difficile infection; Clostridioides difficile recurrence prevention; bezlotoxumab; monoclonal antibody therapy.

Plain language summary

Bezlotoxumab for preventing Clostridioides difficile recurrence: insights from one center and a broader analysis Clostridioides difficile infection (CDI) is a common and serious gut infection that often comes back after treatment. Bezlotoxumab (BEZ) has been shown to reduce the chances of recurrence. This study included a review of 47 patients treated with BEZ at the Mayo Clinic and combined their results with data from 28 other studies involving a total of 2639 CDI patients. Overall, 83.3% of patients treated with BEZ had their infections resolved, compared to 70.8% for patients treated with standard antibiotics alone. At the Mayo Clinic, 72.3% of the 47 patients had their CDI resolved with BEZ treatment. BEZ was found to reduce the risk of recurrence by nearly half (relative risk of 0.56). In conclusion, our study and analysis confirm that BEZ therapy is effective in reducing CDI recurrence in real-world settings. However, higher recurrence rates in high-risk patients, particularly those with weakened immune systems, highlight the importance of future studies to better understand the impact of additional health conditions.

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Conflict of interest statement

K.S., P.B., and R.T.: None. D.S.P.: AbbVie (Consultant), Applied Molecular transport (Grant/Research Support), Finch (Grant/Research Support), Immunic (Consultant), Otsuka (Consultant), Pfizer (Grant/Research Support), Phantom Pharmaceuticals (Consultant), Seres (Consultant, Grant/Research Support), Takeda (Grant/Research Support), and Vedanta (Consultant, Grant/Research Support, outside of submitted work. SK: Research grants from Rebiotix, Inc. (A Ferring company), Seres, Finch, Vedanta, and Pfizer; consulting fees from Takeda, Rise, and ProbioTech Inc., outside of the submitted work.

Figures

Figure 1.
Figure 1.
Clostridioides difficile recurrence rate in our cohort stratified by risk factors.
Figure 2.
Figure 2.
PRISMA flowchart: study selection process for meta-analysis of bezlotoxumab in reducing CDI recurrence. CDI, Clostridioides difficile infection.
Figure 3.
Figure 3.
Forest plot: meta-analysis of CDI resolution rates with bezlotoxumab and standard-of-care therapy. CDI, Clostridioides difficile infection.
Figure 4.
Figure 4.
Forest plot: relative risk of CDI Recurrence with bezlotoxumab and standard-of-care therapy. CDI, Clostridioides difficile infection.
See this image and copyright information in PMC

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