目的:评价eptinezumab治疗青少年慢性难治性头痛的安全性和有效性。
背景:慢性难治性头痛可导致青少年缺课和生活质量受损,目前尚无A级证据的药物治疗可预防该人群的头痛。虽然观察数据表明,降钙素基因相关肽或其受体的单克隆抗体可能对患有难治性原发性头痛疾病的青少年有所帮助,目前缺乏使用eptinezumab的证据.
方法:这是一个单中心,回顾性图表审查。收集人口统计学和头痛表型数据。结果指标包括输注前后的头痛强度和频率,功能或相关症状的改善。还收集了不良事件。
结果:9例慢性偏头痛患者和2例每天新的持续性头痛患者接受了100mg的首次剂量的eptinezumab。所有患者每天都有头痛,9名患者在基线时持续头痛。第一次输注100毫克后,两名患者不再每天头痛,一名患者停止了持续的头痛,四名患者注意到头痛强度降低。此外,一名患者描述了恶心和呕吐的减少,另一名患者注意到功能改善。六名患者接受了第二次100毫克的eptinezumab输注,三个有第三个,和一名患者有四次100毫克的输液。第二次输液后,一名患者注意到头痛频率减少,一个人头痛强度较低,两个描述疼痛“改善”。“有了第三次和第四次输液,患者继续报告头痛强度有所改善.随后输注300mg可进一步降低某些患者的头痛频率和强度。Eptinezumab总体耐受性良好。
结论:虽然这是一个小样本,研究结果表明,eptinezumab可能是一种安全有效的治疗慢性,青少年难治性头痛。
To evaluate the safety and efficacy of eptinezumab for the treatment of chronic refractory headache in adolescents.
Chronic refractory headache can lead to school absences and impaired quality of life in adolescents, and currently there are no pharmacologic treatments with level A evidence for headache prevention for this population. While observational data suggest that monoclonal antibodies to calcitonin gene-related peptide or its receptor may be helpful for adolescents who have refractory primary headache disorders, evidence is lacking for the use of eptinezumab.
This was a single-center, retrospective chart
review. Demographic and headache phenotypic data were collected. Outcome measures included headache intensity and frequency pre- and post-infusion(s), and improvement in function or in associated symptoms. Adverse events were also collected.
Nine patients with chronic migraine and two with new daily persistent headache received a first dose of 100 mg of eptinezumab. All of them had daily headache and nine had continuous headache at baseline. After the first infusion of 100 mg, two patients were no longer having daily headache, one patient stopped having continuous headache, and four patients noted headache intensity reduction. Additionally, one patient described a reduction in nausea and vomiting, and another patient noted improvement in function. Six patients received a second eptinezumab infusion of 100 mg, three had a third one, and one patient had four infusions of 100 mg. After the second infusion, one patient noted reduction in headache frequency, one experienced lower headache intensity, and two described pain \"improving.\" With the third and fourth infusions, patients continued to report improvement in headache intensity. Subsequent infusions of 300 mg resulted in further reductions in headache frequency and intensity for some patients. Eptinezumab was overall well tolerated.
While this was a small sample, findings suggest that eptinezumab may be a safe and effective treatment for chronic, refractory headache in adolescents.