The Warren Alpert Medical School of Brown University.
Gastroenterology and Hepatology Department, Indiana University, Indianapolis, IN.
J Clin Gastroenterol. 2024 Apr 1;58(4):389-401. doi: 10.1097/MCG.0000000000001875.
INTRODUCTION: Clostridioides difficile infection (CDI) remains a global health challenge. Bezlotoxumab (BEZ) is a monoclonal antibody against C. difficile toxin B. Two randomized controlled trials (RCTs), MODIFY I and II, confirmed BEZ efficacy in preventing recurrent Clostridioides difficile infection (rCDI). However, there are safety concerns about its use in patients with a history of congestive heart failure. Observational studies have since been conducted, and it is important to explore the consistency of BEZ efficacy, cost-effectiveness, and its safety utilizing these real-world data. METHODS: We performed a systematic review and meta-analysis to pool the rate of rCDI in patients receiving BEZ and explore its efficacy and safety in preventing rCDI compared with control. We searched PubMed, EMBASE, Cochrane Library, and Google Scholar from inception through April 2023 for relevant RCTs or observational studies assessing BEZ in preventing rCDI. Single-arm studies describing experience with BEZ in preventing rCDI were also included for proportion meta-analysis. A proportion meta-analysis with a random-effects model was used to pool the rCDI rate with its corresponding 95% CI. In a meta-analysis of efficacy, we generated the relative risk (RR) to compare BEZ versus control in preventing rCDI. RESULTS: Thirteen studies including 2 RCTs and 11 observational studies totaling 2337 patients, of which 1472 received BEZ, were included in the analysis. Of the constituent studies, 5 (1734 patients) compared BEZ versus standard-of-care (SOC). Pooled rate of rCDI in patients receiving BEZ was 15.8% (95% CI: 14%-17.8%), and was 28.9% (95% CI: 24%-34.4%) in the SOC. BEZ significantly reduced rCDI risk compared with SOC [RR=0.57 (95% CI: 0.45-0.72, I2 =16%)]. There was no difference in the overall mortality or heart failure risk. Of the 9 included cost-effectiveness analyses, 8 demonstrated BEZ+SOC cost-effectiveness compared with SOC alone. DISCUSSION: Our meta-analysis comprising real-world data revealed lower rCDI in patients receiving BEZ and supported its efficacy and safety when added to SOC therapy. The results were consistent across various subgroups. Available cost-effectiveness analyses mostly support BEZ+SOC cost-effectiveness compared with SOC alone.
简介：艰难梭菌感染（CDI）仍然是一个全球性的健康挑战。贝左妥珠单抗（BEZ）是一种针对艰难梭菌毒素 B 的单克隆抗体。两项随机对照试验（RCT），MODIFY I 和 II，证实了 BEZ 在预防复发性艰难梭菌感染（rCDI）方面的疗效。然而，人们对其在有充血性心力衰竭病史的患者中的使用安全性存在担忧。此后进行了观察性研究，利用这些真实世界的数据来探讨 BEZ 的疗效、成本效益和安全性的一致性非常重要。 方法：我们进行了系统评价和荟萃分析，以汇总接受 BEZ 治疗的患者中 rCDI 的发生率，并探讨其与对照组相比预防 rCDI 的疗效和安全性。我们从开始到 2023 年 4 月在 PubMed、EMBASE、Cochrane 图书馆和 Google Scholar 上搜索了评估 BEZ 预防 rCDI 的相关 RCT 或观察性研究。还包括了描述 BEZ 预防 rCDI 经验的单臂研究，用于比例荟萃分析。使用随机效应模型的比例荟萃分析来汇总 rCDI 发生率及其相应的 95%置信区间。在疗效的荟萃分析中，我们生成了相对风险（RR），以比较 BEZ 与对照组预防 rCDI 的效果。 结果：共有 13 项研究（包括 2 项 RCT 和 11 项观察性研究）纳入了 2337 名患者，其中 1472 名接受了 BEZ 治疗。在纳入的研究中，5 项（1734 名患者）比较了 BEZ 与标准治疗（SOC）。接受 BEZ 治疗的患者 rCDI 的发生率为 15.8%（95%CI：14%-17.8%），SOC 组的 rCDI 发生率为 28.9%（95%CI：24%-34.4%）。BEZ 与 SOC 相比显著降低了 rCDI 的风险[RR=0.57（95%CI：0.45-0.72，I2=16%）]。总体死亡率或心力衰竭风险无差异。在纳入的 9 项成本效益分析中，有 8 项表明 BEZ+SOC 比 SOC 单独治疗更具成本效益。 讨论：我们的荟萃分析包括真实世界的数据，结果显示接受 BEZ 治疗的患者 rCDI 发生率较低，并支持其在 SOC 治疗基础上的疗效和安全性。结果在各种亚组中一致。现有的成本效益分析大多支持 BEZ+SOC 比 SOC 单独治疗更具成本效益。
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