a Department of Medicine , Harvard Medical School , Boston , MA.
b Department of Medicine - Division of Hematology and Oncology , Beth Israel Deaconess Medical Center , Boston , MA , USA.
Expert Rev Gastroenterol Hepatol. 2017 Jul;11(7):611-622. doi: 10.1080/17474124.2017.1344551. Epub 2017 Jun 26.
Clostridium difficile infection (CDI) is the most common nosocomial infection in the U.S. 25% of CDI patients go on to develop recurrent CDI (rCDI) following current standard of care (SOC) therapy, leading to morbidity, mortality and economic loss. The first passive immunotherapy drug targeting C.difficile toxin B (bezlotoxumab) has been approved recently by the FDA and EMA for prevention of rCDI. Areas covered: A body of key studies was selected and reviewed by the authors. The unmet needs in CDI care were ascertained with emphasis in rCDI, including the epidemiology, pathophysiology and current management. The current knowledge about the immune response to C. difficile toxins and how this knowledge led to the development and the clinical use of bezlotoxumab is described. Current and potential future competitors to the drug were examined. Expert commentary: A single 10 mg/kg intravenous infusion of bezlotoxumab has been shown to decrease rCDI by ~40% (absolute reduction ~10%) in patients being treated for primary CDI or rCDI with SOC antibiotics. Targeting C.difficile toxins by passive immunotherapy is a novel mechanism for prevention of C.difficile infection. Bezlotoxumab will be a valuable adjunctive therapy to reduce the burden of CDI.
艰难梭菌感染（CDI）是美国最常见的医院获得性感染。25%的 CDI 患者在接受当前标准治疗（SOC）后会继续发展为复发性 CDI（rCDI），导致发病率、死亡率和经济损失。最近，FDA 和 EMA 批准了第一种针对艰难梭菌毒素 B（贝洛妥珠单抗）的被动免疫疗法药物，用于预防 rCDI。
作者选择并审查了一系列关键研究。确定了 CDI 治疗中的未满足需求，重点是 rCDI，包括流行病学、病理生理学和当前管理。描述了对艰难梭菌毒素的免疫反应的现有知识，以及如何利用这些知识开发和临床应用贝洛妥珠单抗。还研究了该药物的当前和潜在未来竞争对手。
在接受 SOC 抗生素治疗原发性 CDI 或 rCDI 的患者中，单次 10mg/kg 的静脉注射贝洛妥珠单抗可将 rCDI 降低约 40%（绝对减少约 10%）。通过被动免疫疗法靶向艰难梭菌毒素是预防艰难梭菌感染的一种新机制。贝洛妥珠单抗将成为一种有价值的辅助治疗方法，以减轻 CDI 的负担。
