Fremanezumab in Children and Adolescents with Episodic Migraine.

Evidence from randomized, controlled trials in children and adolescents is needed.

需要来自儿童和青少年的随机对照试验的证据。

Methods

We randomly assigned participants 6 to 17 years of age with a diagnosis of episodic migraine (defined as migraine for ≥6 months and a history of ≤14 headache days per month) to receive monthly subcutaneous injections of fremanezumab (120 mg for participants with a body weight of <45 kg and 225 mg for those with a body weight of ≥45 kg) or matched placebo for 3 months.

我们随机分配了6至17岁被诊断为发作性偏头痛（定义为偏头痛持续≥6个月，每月头痛天数≤14天）的参与者，接受每月一次的皮下注射fremanezumab（对于体重<45公斤的参与者为120毫克，对于体重≥45公斤的参与者为225毫克）或匹配安慰剂，为期3个月。

Participants were allowed to use migraine-specific medications to treat acute headaches.

允许参与者使用偏头痛特异性药物治疗急性头痛。

The primary end point was the change from baseline in the average number of migraine days per month.

主要终点是基线时每月平均偏头痛天数的变化。

Key secondary end points included the change in the number of days per month with headache of at least moderate severity and a reduction of 50% or more in the number of migraine days per month.

关键次要终点包括每月头痛至少中度严重程度的天数变化，以及每月偏头痛天数减少50%或更多。

Results

Of 237 participants who underwent randomization, 234 were included in the full analysis population: 123 in the fremanezumab group (36 received the 120-mg dose and 87 received the 225-mg dose) and 111 in the placebo group.

在随机化的237名参与者中，有234名被纳入全分析人群：123名在fremanezumab组（36人接受了120mg剂量，87人接受了225mg剂量），111名在安慰剂组。

Fremanezumab reduced the number of migraine days per month by 2.5 as compared with 1.4 with placebo (difference, 1.1; P = 0.02) and the number of days per month with headache of at least moderate severity by 2.6 as compared with 1.5 with placebo (difference, 1.1; P = 0.02).

与安慰剂相比，fremanezumab将每月偏头痛天数减少了2.5天，而安慰剂组为1.4天（差异，1.1天；P = 0.02），并且将每月至少中度严重程度头痛天数减少了2.6天，而安慰剂组为1.5天（差异，1.1天；P = 0.02）。

The percentage of participants who had a reduction of 50% or more in the number of migraine days per month was 47.2% with fremanezumab and 27.0% with placebo (P = 0.002).

接受弗雷马珠单抗治疗的参与者中，每月偏头痛天数减少50%或以上的比例为47.2%，而安慰剂组为27.0%（P = 0.002）。

Injection-site erythema was the most common adverse eventwith fremanezumab (9.8% of participants, vs. 5.4% with placebo).

注射部位红斑是弗雷马珠单抗最常见的不良事件（占参与者的9.8%，与安慰剂组的5.4%相比）。

Conclusions

Among children and adolescents with episodic migraine, fremanezumab resulted in greater reductions in the number of migraine days and headache days than placebo.

在患有偶发性偏头痛的儿童和青少年中，fremanezumab 导致的偏头痛天数和头痛天数减少量大于安慰剂。

Injection-site erythema was the most common adverse eventwith fremanezumab.

注射部位红斑是 fremanezumab 最常见的不良事件。

Longer follow-up is required to further understand the efficacy and safety of the drug in this population.

需要更长时间的随访来进一步了解该药物在这一人群中的疗效和安全性。

(Funded by Teva Pharmaceuticals; ClinicalTrials.gov number, NCT04458857.).

(由梯瓦制药资助；ClinicalTrials.gov编号，NCT04458857。)