Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence.
Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence.
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DOI：
10.1093/cid/ciy171
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发表时间：
2018-08-16
期刊：
影响因子：
--
通讯作者：
Dorr MB
中科院分区：
文献类型：
--
作者：
Gerding DN;Kelly CP;Rahav G;Lee C;Dubberke ER;Kumar PN;Yacyshyn B;Kao D;Eves K;Ellison MC;Hanson ME;Guris D;Dorr MB
Bezlotoxumab 是一种针对艰难梭菌毒素 B 的人单克隆抗体，可预防艰难梭菌感染 (CDI) 复发 (rCDI) 成人的 rCDI 高风险人群。这项针对艰难梭菌治疗 (MODIFY) I/II 数据的汇总单克隆抗体的事后分析评估了贝洛妥单抗在具有 rCDI 风险增加相关特征的参与者中的疗效。分析人群是根据统计分析计划中预先指定的 rCDI 危险因素接受贝洛妥单抗或安慰剂的改良意向治疗人群 (n = 1554)：年龄≥65 岁、CDI 病史、免疫力受损、严重 CDI 和核糖型 027/078/244。报告显示了 12 周内患有 rCDI 的参与者比例、粪便微生物群移植手术、30 天全因和 CDI 相关医院再入院率，以及随机分组后 30 和 90 天的死亡率。大多数登记参与者（75.6%）有≥1个危险因素；与没有危险因素的参与者相比，这些参与者年龄较大，患有合并症的比例更高。对于每个危险因素，经历过 rCDI 的安慰剂参与者的比例超过 30%，而没有危险因素的参与者中，rCDI 的比例为 20.9%，并且 rCDI 发生率随着危险因素数量的增加而增加（1 个危险因素：31.3%；≥3 个危险因素：46.1%）。 Bezlotoxumab 减少了具有 rCDI 危险因素的参与者的 rCDI、粪便微生物群移植和 CDI 相关的 30 天再入院率。 MODIFY 统计分析计划中预先指定的风险因素适合识别 rCDI 高风险患者。虽然具有 ≥ 3 个危险因素的参与者使用贝洛妥单抗可最大程度地降低 rCDI，但具有 1 或 2 个危险因素的参与者也可能受益。 NCT01241552（修改 I）和 NCT01513239（修改 II）。 MODIFY 的亚组分析证实，既往艰难梭菌感染 (CDI)、年龄≥65 岁、感染 027/078/244 菌株、免疫力受损和严重 CDI 是复发 CDI 的危险因素。与安慰剂相比，Bezlotoxumab 可减少具有≥1 个危险因素的参与者的 CDI 复发。
Bezlotoxumab is a human monoclonal antibody against Clostridium difficile toxin B indicated to prevent C. difficile infection (CDI) recurrence (rCDI) in adults at high risk for rCDI. This post hoc analysis of pooled monocolonal antibodies for C.difficile therapy (MODIFY) I/II data assessed bezlotoxumab efficacy in participants with characteristics associated with increased risk for rCDI. The analysis population was the modified intent-to-treat population who received bezlotoxumab or placebo (n = 1554) by risk factors for rCDI that were prespecified in the statistical analysis plan: age ≥65 years, history of CDI, compromised immunity, severe CDI, and ribotype 027/078/244. The proportion of participants with rCDI in 12 weeks, fecal microbiota transplant procedures, 30-day all cause and CDI-associated hospital readmissions, and mortality at 30 and 90 days after randomization were presented. The majority of enrolled participants (75.6%) had ≥1 risk factor; these participants were older and a higher proportion had comorbidities compared with participants with no risk factors. The proportion of placebo participants who experienced rCDI exceeded 30% for each risk factor compared with 20.9% among those without a risk factor, and the rCDI rate increased with the number of risk factors (1 risk factor: 31.3%; ≥3 risk factors: 46.1%). Bezlotoxumab reduced rCDI, fecal microbiota transplants, and CDI-associated 30-day readmissions in participants with risk factors for rCDI. The risk factors prespecified in the MODIFY statistical analysis plan are appropriate to identify patients at high risk for rCDI. While participants with ≥3 risk factors had the greatest reduction of rCDI with bezlotoxumab, those with 1 or 2 risk factors may also benefit. NCT01241552 (MODIFY I) and NCT01513239 (MODIFY II). Subgroup analyses from MODIFY confirmed that prior Clostridium difficile infection (CDI), age ≥65 years, infection with 027/078/244 strain, compromised immunity, and severe CDI are risk factors for recurrent CDI. Bezlotoxumab reduced CDI recurrence in participants with ≥1 risk factor compared with placebo.
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