Clostridium difficile infection (CDI) is mediated by actions of toxin A and toxin B. Fully human monoclonal antibodies directed against the binding domains of these toxins were developed. Despite preclinical studies suggesting efficacy for the anti–toxin A monoclonal, actoxumab, the anti–toxin B monoclonal, bezlotoxumab, alone was shown to be effective in clinical trials. Intravenous infusion of bezlotoxumab at a 10 mg/kg dosage as adjunctive treatment reduced the risk of recurrent CDI over placebo for adult patients at increased risk for CDI recurrence in 2 large randomized, double-blind trials. Significant benefit was noted for patients with 1 or more of the following predefined risks: age >65 years, history of CDI, immunocompromise, severe CDI. Overall, bezlotoxumab appeared to be safe; however, an unexplained increased risk of heart failure was noted for patients with underlying congestive heart failure. Further refinement of who would benefit most and when best to administer bezlotoxumab is warranted.

中文翻译：

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贝索洛单抗

艰难梭菌感染（CDI）是由毒素A和毒素B的作用介导的。开发了针对这些毒素结合域的完全人类单克隆抗体。尽管临床前研究表明，抗毒素A单克隆抗体，阿昔单抗，抗毒素B单克隆抗体，贝洛酮单抗的疗效在临床试验中均有效。在两项大型，随机，双盲试验中，静脉输注10mg / kg倍他洛单抗作为辅助治疗可降低CDI复发风险的成年患者比安慰剂降低CDI复发的风险。对于具有以下一种或多种预定义风险的患者，注意到了显着的益处：年龄> 65岁，CDI病史，免疫功能低下，严重CDI。总体而言，贝洛酮单抗似乎是安全的；然而，潜在的充血性心力衰竭患者出现无法解释的心力衰竭风险增加。有必要进一步完善谁将受益最大以及何时最佳施用贝洛酮单抗的方法。