Vilobelimab的临床疗效和安全性(IFX-1),小说单克隆Anti-C5a抗体,患者早期严重脓毒症或脓毒性震动一个随机、安慰剂对照、双盲、多中心、活动花絮阶段试验(三英洁具的研究)。

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,鲍尔M。维兰德提出马克思G, Bloos F,韦伯年代,维勒N,年代,克鲁格Diers,西蒙•TP Lautenschlager我Grundling M, Jaschinski U,西蒙•P Nierhaus, Moerer O, Reill L, Jorres,郭R,吕弗勒M,莱因哈特K, Riedemann N

暴击保健空洞。2021年11月17日,3 (11):e0577。doi: 10.1097 / CCE.0000000000000577。eCollection 2021年11月。

PubMed ID

34806021 (在PubMed

]

文摘

过敏毒素C5a,促炎的补充产品,在调节器官功能障碍中起着重要的作用。目的:这二期临床试验进行了研究安全,耐受性,药物动力学和药效学vilobelimab,对C5a重组单克隆抗体,在严重脓毒症或脓毒性休克患者。设计:多中心,随机,安慰剂对照研究。设置和参与者:十一个多学科icu在德国。成人严重脓毒症或脓毒性休克患者和infection-associated器官功能障碍的早期发病。主要结果和措施:病人被随机分配在2:1的比率为IV vilobelimab随后三个剂量组或安慰剂接收2 x 2毫克/公斤(0和12小时),2 x 4毫克/公斤(0和24小时),和3 x 4毫克/公斤(0、24和72小时)。Co-primary端点是药效学(评估C5a浓度),药物动力学vilobelimab浓度(评估),vilobelimab和安全。初步疗效评估的次要目标。结果:七十二名患者被随机分配为每个vilobelimab剂量组(16例和8个病人安慰剂给药组)。Vilobelimab应用与剂量依赖C5a与基线相比下降(p < 0.001)。 Duration of C5a decrease increased with more frequent dosing. Membrane attack complex lysis capacity measured by 50% hemolytic complement was not affected. Vilobelimab was well tolerated with similar safety findings in all dose cohorts. No vilobelimab-specific adverse events emerged. For vilobelimab-treated patients, investigators attributed less treatment-emergent adverse events as related compared with placebo. Dosing cohorts 2 and 3 had the highest ICU-free and ventilator-free days. There was no difference in mortality, vasopressor-free days, or renal replacement therapy-free days between the groups. CONCLUSIONS AND RELEVANCE: Administration of vilobelimab in patients with severe sepsis and septic shock selectively neutralizes C5a in a dose-dependent manner without blocking formation of the membrane attack complex and without resulting in detected safety issues. The data warrant further investigation of C5a inhibition in sepsis.

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药物: Vilobelimab