{"title":"Real-world use of bezlotoxumab to prevent recurrent <i>Clostridioides difficile</i> infections: a single-center experience and meta-analysis.","authors":"Kanika Sehgal, Parul Berry, Raseen Tariq, Darrell S Pardi, Sahil Khanna","doi":"10.1177/17562848251346593","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong><i>Clostridioides difficile</i> 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.</p><p><strong>Objectives: </strong>To evaluate the real-world effectiveness of BEZ in preventing CDI recurrence through a single-center retrospective cohort and a meta-analysis.</p><p><strong>Design: </strong>A retrospective cohort study and a meta-analysis.</p><p><strong>Methods: </strong>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>I</i> <sup>2</sup>) statistic.</p><p><strong>Results: </strong>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 (<i>I</i>² = 77.3%). In subgroup analysis, the pooled relative risk of recurrence was 0.56 (95% CI 0.36-0.88; <i>p</i> < 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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251346593"},"PeriodicalIF":3.4000,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12182605/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251346593","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
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 (I2) 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.
背景：在临床试验中，用bezlotoxumab （BEZ）治疗艰难梭菌感染（CDI）的复发率已被证明低于安慰剂。然而，关于BEZ有效性的实际数据仍然有限且不一致。目的：通过单中心回顾性队列和荟萃分析评估BEZ在预防CDI复发方面的实际有效性。设计：回顾性队列研究和荟萃分析。方法：对梅奥诊所2017年至2021年接受BEZ治疗的患者进行回顾性研究。分析了人口统计学、CDI诊断和几个预先指定的危险因素。文献检索于2024年8月利用Cochrane中央对照试验注册库、Embase、Medline、Scopus和Web of Science核心馆藏进行。研究报告了BEZ治疗CDI的治愈率。采用DerSimonian和Laird描述的随机效应模型计算加权池分辨率（WPR），置信区间为95%。我们用不一致指数（i2）统计来评估异质性。结果：在28项研究和我们的回顾性队列中，分析了2639例CDI患者。在接受BEZ治疗的1786例患者中，1450例达到临床缓解（WPR: 81.6%, 95% CI 77.2-85.6%），异质性显著（I²= 77.3%）。在亚组分析中，合并相对复发风险为0.56 (95% CI 0.36-0.88；结论：我们的回顾性研究和荟萃分析证明了BEZ在减少CDI复发方面的实际疗效。在我们的队列中，较高的复发率可能反映了人群的高风险性质，包括免疫功能低下患者的较大比例。
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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