Calcitonin Gene-Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents.
Calcitonin Gene-Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents.
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DOI：
10.1016/j.pediatrneurol.2020.09.014
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发表时间：
2021-01
影响因子：
3.8
通讯作者：
Irwin SL
中科院分区：
文献类型：
--
作者：
Greene KA;Gentile CP;Szperka CL;Yonker M;Gelfand AA;Grimes B;Irwin SL
降钙素基因相关肽（CGRP）或其受体单克隆抗体（mab）在成人头痛患者中有临床试验证据，但在青少年中缺乏相关数据。目的探讨CGRP单克隆抗体（mAb）治疗青少年慢性头痛疾病的安全性和有效性。回顾性多地点队列研究<18岁的青少年处方CGRP单抗预防头痛。收集人口统计学、基线头痛特征、疗效和副作用数据。n=112名青少年接受了≥1剂量的CGRP单抗治疗。首次给药的平均（SD；范围）年龄为15.9岁（1.4岁；10.3至17.8岁）。94例（83.9%）患有慢性偏头痛，12例（10.7%）患有NDPH， 6例（5.4%）患有PPTH。基线时，每月平均头痛天数（SD）为26.9（6.1）天（n=109）， 75/111（67.6%）患者持续头痛。随访1时，与基线相比，头痛频率显著降低（- 2.0天，95% CI: - 0.8至- 3.2）。29.5%的患者在随访第1次（n=33/112）和30.1%的患者在随访第2次（n=22/73）时感觉显著获益。在第一次随访时，31% （n=31/94）和22.4% （n=15/67）的患者感觉功能显著改善。最常见的副作用是注射部位反应（17.0%）和便秘（8.0%）（n=9）。5名患者（4.5%）因副作用停药。在青少年中使用CGRP单抗治疗的副作用与在成人试验中报道的相似。CGRP单克隆抗体治疗似乎有利于一部分患有慢性难治性头痛疾病的青少年
Monoclonal antibodies (mAbs) to calcitonin gene-related peptide (CGRP) or its receptor have clinical trial evidence in adults with headache, but data are lacking in adolescents. To describe the safety and efficacy of CGRP monoclonal antibody (mAb) treatment in adolescents with chronic headache disorders. Retrospective multi-site cohort study of adolescents <18 years prescribed a CGRP mAb for headache prevention. Demographics, baseline headache characteristics, efficacy and side effect data was collected. n=112 adolescents received ≥1 dose of a CGRP mAb. Mean (SD; range) age at first dose was 15.9 years (1.4; 10.3 to 17.8). Ninety-four (83.9%) had chronic migraine, 12 (10.7%) had NDPH, and 6 (5.4%) had PPTH. At baseline, mean (SD) baseline headache days per month was 26.9 (6.1) (n=109) and headache was continuous in 75/111 (67.6%). At follow-up visit 1 there was a significant reduction in headache frequency compared to baseline (−2.0 days, 95% CI: −0.8 to −3.2). Significant benefit was perceived by 29.5% at follow-up visit 1 (n=33/112) and 30.1% (n=22/73) at visit 2. Significant functional improvement was perceived by 31% (n=31/94) at the 1st follow-up and 22.4% (n=15/67) at the 2nd follow-up. 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 due to side effects. Side effects with CGRP mAb treatment in adolescents are similar to those reported in adult trials. CGRP monoclonal antibody treatment appears to benefit a proportion of adolescents with chronic refractory headache disorders
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