Background

Monoclonal antibodies to calcitonin gene–related peptide or its receptor have clinical trial evidence in adults with headache, but data are lacking in adolescents. The objective of this study was to describe the safety and efficacy of calcitonin gene–related peptide monoclonal antibody treatment in adolescents with chronic headache disorders.

Methods

We performed a retrospective multisite cohort study of patients less than 18 years of age who received a calcitonin gene–related peptide monoclonal antibody for headache prevention. Demographics, baseline headache characteristics, efficacy, and side effect data were collected.

Results

The study population comprised 112 adolescents who received at least one dose of a calcitonin gene–related peptide monoclonal antibody. Mean (S.D.; range) age at first dose was 15.9 years (1.4; 10.3 to 17.8). Ninety-four patients (83.9%) had chronic migraine, 12 (10.7%) had new daily persistent headache, and six (5.4%) had persistent post-traumatic headache. At baseline, the mean (S.D.) number of headache days per month was 26.9 (6.1) (n = 109) and headache was continuous in 75 of 111 (67.6%). At first follow-up visit there was a significant reduction in headache frequency compared with baseline (−2.0 days; 95% confidence interval, −0.8 to −3.2). Significant benefit was perceived by 29.5% of patients at first follow-up visit (n = 33/112) and 30.1% (n = 22/73) at second follow-up visit. A significant functional improvement was perceived by 31% of patients (n = 31/94) at the first follow-up visit and 22.4% (n = 15/67) at the second follow-up visit. The most common side effects were injection site reactions in 17.0% (n = 19) and constipation in 8.0% (n = 9). Five patients (4.5%) discontinued because of side effects.

Conclusions

Side effects with calcitonin gene–related peptide monoclonal antibody treatment in adolescents were similar to those reported in adult trials. Calcitonin gene–related peptide monoclonal antibody treatment appears to benefit a proportion of adolescents with chronic refractory headache disorders.

中文翻译：

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降钙素基因相关肽单克隆抗体用于预防性治疗青少年难治性头痛疾病

 背景

降钙素基因相关肽或其受体的单克隆抗体在成人头痛中具有临床试验证据，但在青少年中缺乏数据。本研究的目的是描述降钙素基因相关肽单克隆抗体治疗患有慢性头痛疾病的青少年的安全性和有效性。

 方法

我们对接受降钙素基因相关肽单克隆抗体预防头痛的 18 岁以下患者进行了一项回顾性多中心队列研究。收集人口统计学、基线头痛特征、疗效和副作用数据。

 结果

研究人群包括 112 名青少年，他们至少接受了一剂降钙素基因相关肽单克隆抗体。首次接种时的平均（SD；范围）年龄为 15.9 岁（1.4；10.3 至 17.8）。 94 名患者 (83.9%) 患有慢性偏头痛，12 名患者 (10.7%) 患有新发的每日持续性头痛，6 名患者 (5.4%) 患有持续性外伤后头痛。基线时，每月头痛的平均 (SD) 天数为 26.9 (6.1) ( n = 109)，111 人中有 75 人 (67.6%) 持续头痛。第一次随访时，与基线相比，头痛频率显着降低（-2.0 天；95% 置信区间，-0.8 至 -3.2）。 29.5% 的患者在第一次随访时 (n = 33/112) 和 30.1% (n = 22/73) 在第二次随访时感觉到显着获益。 31% 的患者 (n = 31/94) 在第一次随访时感觉功能显着改善，22.4% (n = 15/67) 在第二次随访时感觉功能显着改善。最常见的副作用是注射部位反应（17.0%）（n = 19）和便秘（8.0%）（n = 9）。五名患者 (4.5%) 由于副作用而停药。

 结论

青少年降钙素基因相关肽单克隆抗体治疗的副作用与成人试验中报告的副作用相似。降钙素基因相关肽单克隆抗体治疗似乎对部分患有慢性难治性头痛的青少年有益。