BACKGROUND Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults. OBJECTIVE To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine. METHODS In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia. RESULTS Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: -1.4 [95% confidence interval: -1.84, -0.89], p < 0.001; quarterly: -1.3 [-1.76, -0.82], p < 0.001) and migraine-specific acute headache medication use (monthly: -2.2 [-2.80, -1.56], p < 0.001; quarterly: -2.2 [-2.81, -1.58], p < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo. CONCLUSIONS Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine. TRIAL REGISTRATION Clinicaltrials.gov NCT02629861.

中文翻译：

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fremanezumab 对发作性偏头痛患者使用急性头痛药物和偏头痛相关症状的影响。

背景 Fremanezumab 是一种靶向降钙素基因相关肽的全人源化单克隆抗体，已证明对成人偏头痛的预防性治疗有效。目的 评估 fremanezumab 治疗对发作性偏头痛患者急性头痛药物使用和偏头痛相关症状的影响。方法 在 HALO 3 期试验中，发作性偏头痛患者随机接受皮下注射 fremanezumab（基线时 225 mg，第 4 周和第 8 周）、每季度一次 fremanezumab（基线时 675 mg，第 4 周和第 8 周安慰剂）或安慰剂一个 12 周的时间。次要终点是使用任何急性头痛药物或偏头痛特异性急性头痛药物后每月天数与基线相比的变化；探索性终点是每月出现恶心或呕吐、畏光或畏声的天数自基线的变化。结果 在随机分配的 875 名患者中，865 名被纳入分析（每月，n = 287；每季度，n = 288；安慰剂，n = 290）。基线平均值 ± 标准差天数：任何急性头痛药物使用（每月：7.7 ± 3.4；每季度：7.8 ± 3.7；安慰剂：7.7 ± 3.6），偏头痛特异性急性头痛药物使用（6.1 ± 3.1；6.6 ± 3.1；7.1 ± 3.0)、恶心或呕吐 (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) 以及畏光和畏声 (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) 在治疗组之间相似。Fremanezumab 减少了急性头痛药物使用的天数（[最小二乘平均变化与安慰剂相比] 每月：-1.4 [95% 置信区间：-1.84，-0.89]，p < 0.001；每季度：-1.3 [-1.76 , -0.82], p < 0.001）和偏头痛特异性急性头痛药物使用（每月：-2.2 [-2.80，-1.56]，p < 0.001；季度：-2.2 [-2.81，-1.58]，p < 0.001）与安慰剂相比。与安慰剂相比，Fremanezumab 还减少了恶心或呕吐、畏光和畏声。结论 Fremanezumab 减少了对急性头痛药物的需求，包括偏头痛特异性药物，同时治疗发作性偏头痛患者的偏头痛相关症状。试验注册 Clinicaltrials.gov NCT02629861。结论 Fremanezumab 减少了对急性头痛药物的需求，包括偏头痛特异性药物，同时治疗发作性偏头痛患者的偏头痛相关症状。试验注册 Clinicaltrials.gov NCT02629861。结论 Fremanezumab 减少了对急性头痛药物的需求，包括偏头痛特异性药物，同时治疗发作性偏头痛患者的偏头痛相关症状。试验注册 Clinicaltrials.gov NCT02629861。