A Controlled Trial of Erenumab for Episodic Migraine
A Controlled Trial of Erenumab for Episodic Migraine
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DOI：
10.1056/nejmoa1705848
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发表时间：
2017-11-30
影响因子：
158.5
通讯作者：
Lenz, Robert A.
中科院分区：
文献类型：
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作者：
Goadsby, Peter J.;Reuter, Uwe;Lenz, Robert A.
研究背景我们测试了erenumab，一种抑制降钙素基因相关肽受体的全人单克隆抗体，用于预防发作性偏头痛。方法我们随机分配患者接受皮下注射erenumab，剂量为70 mg或140 mg，或安慰剂，每月一次，持续6个月。主要终点是从基线到第4个月到第6个月每月平均偏头痛天数的变化。次要终点是每月平均偏头痛天数减少50%或更多，急性偏头痛特异性药物使用天数的变化，以及偏头痛身体功能影响日记中身体损害和日常活动领域评分的变化（量表转换为0至100，分数越高表示偏头痛对功能的负担越大）。317名被分配到70 mg erenumab组，319名分配到140 mg erenumab组，319名分配到安慰剂组。总体人群中，基线时每月平均偏头痛天数为8.3天;到第4个月至第6个月，70 mg erenumab组和140 mg erenumab组的偏头痛天数分别减少了3.2天和3.7天，而安慰剂组为1.8天（P
BACKGROUNDWe tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, for the prevention of episodic migraine.METHODSWe randomly assigned patients to receive a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month. Secondary end points were a 50% or greater reduction in mean migraine days per month, change in the number of days of use of acute migraine-specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher scores representing greater migraine burden on functioning).RESULTSA total of 955 patients underwent randomization: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group. The mean number of migraine days per month at baseline was 8.3 in the overall population; by months 4 through 6, the number of days was reduced by 3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as compared with 1.8 days in the placebo group (P