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一种针对PACAP的单克隆抗体,用于预防偏头痛

Messoud Ashina¹, Ravinder Phul¹, Melanie Khodaie¹

¹From the Department of Neurology, Danish Headache Center, Copenhagen University Hospital-Rigshospitalet (M.A.), the Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen (M.A.), and H. Lundbeck (R.P., M.K., E.L., I.F.) - all in Copenhagen.

The New England journal of medicine

|September 4, 2024

概括

一种新的偏头痛治疗,Lu AG09222,向 pituitary adenylate cyclase-activating polypeptide (PACAP),在第二阶段试验中显著减少了每月偏头痛的日子. 这种抗体对先前治疗失败的患者的偏头痛预防有前途.

科学领域:

神经学神经学
药理学药理学是指药理学的学科.
免疫学免疫学免疫学

背景情况:

pituitary adenylate cyclase-activating polypeptide (PACAP) 是一种新的治疗点,用于治疗偏头痛.
针对PACAP的单克隆抗体Lu AG09222在偏头痛预防中的有效性和安全性仍在研究中.

研究的目的:

评估静脉注射Lu AG09222在预防成年人中偏头痛的疗效和安全性,这些成年人有史以来对标准预防疗法反应不足.

主要方法:

进行了第二阶段,双盲,随机,安慰剂对照试验.
患有偏头痛的成年参与者接受了750毫克Lu AG09222,100毫克Lu AG09222或安慰剂的单次输注.
主要终点是前4周每月偏头痛日数与基线的变化.

主要成果:

服用750毫克的Lu AG09222组每月平均减少了6.2个偏头痛日,而安慰剂组的4.2天 (P=0.02).
这代表了在4周内偏头痛减少2.0天的统计学显著差异.
像COVID-19,鼻炎和疲劳等不良事件在750毫克Lu AG09222组中稍微更常见.

结论:

750毫克Lu AG09222的单次静脉输液在4周内减少偏头痛频率方面表现出优于安慰剂的优势.
卢AG09222为偏头痛预防提供了一个潜在的新疗法选择.

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