The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with ≥ 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239).

中文翻译：

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参加Bezlotoxumab MODIFY I和II试验的欧洲参与者的艰难梭菌感染相关结果分析。

MODIFY I / II试验表明，贝佐洛单抗是一种针对艰难梭菌毒素B的人单克隆抗体，在艰难梭菌感染（CDI）的抗生素治疗期间给予治疗，可显着降低高危rCDI成年人的艰难梭菌复发（rCDI）。CDI指导干预的有效性可能取决于核糖型区域流行病学和患者特征。事后分析评估了贝洛酮单抗在欧洲注册的MODIFY I / II试验参与者亚组中的疗效。比较来自MODIFY I / II的bezlotoxumab（单次静脉输注10 mg / kg）和安慰剂（0.9％生理盐水）组的数据，以评估30天内的初始临床治愈（ICC），rCDI，全因和CDI相关的再次住院治疗出院天数，以及输液后12周内的死亡率。在全球1554名参与者中，有606名来自欧洲（贝洛酮单抗n = 313，占51％；安慰剂n = 292；占48％）。各组的基线特征通常相似，尽管与安慰剂（20.1％）相比，贝洛酮单抗组（27.2％）的免疫受损参与者更多。55％的参与者是女性，随机分配了86％的住院率。治疗组之间ICC的发生率相似。总体而言，在欧洲参与者以及rCDI风险因素≥1的参与者中，贝洛酮单抗组的rCDI率低于安慰剂。与安慰剂相比，贝洛酮单抗减少了30天的CDI相关的再次住院治疗。这些结果与MODIFY试验的总体结果一致，并证明贝洛酮单抗可降低欧洲CDI患者的rCDI和CDI相关的住院治疗。修改I / II（NCT01241552和NCT01513239）。