关键词: Biological therapy Meta-analysis Migraine Monoclonal antibody Neurology Systematic review

Mesh : Humans Migraine Disorders / drug therapy Antibodies, Monoclonal, Humanized / therapeutic use adverse effects Calcitonin Gene-Related Peptide Receptor Antagonists / therapeutic use adverse effects pharmacology Treatment Outcome

来  源:   DOI:10.1016/j.ejphar.2024.176702

Abstract:
BACKGROUND: Migraine is a common and disabling primary headache disorder. Several drugs targeting calcitonin gene-related peptide (CGRP), such as erenumab (an anti-CGRP receptor mAb), have been developed recently. However, the real-world effects of erenumab are not well understood.
OBJECTIVE: To assess the clinical effectiveness and safety of erenumab for reducing migraine intensity and frequency in the real world.
METHODS: A systematic search of PubMed, Scopus, Web of Science and the Cochrane Library was conducted from inception to December 2023. Studies estimating the real-world effect of erenumab on monthly migraine days (MMD), monthly headache days (MHD), headache impact test (HIT-6), number of days in medication (NDM), acute monthly intake (AMI), pain intensity (PI) and safety outcomes were included. Meta-analyses of proportions or mean differences were performed.
RESULTS: Fifty-three studies were included. At 3-months, the effect was -7.18 days for MMD, -6.89 days for MHD, -6.97 for HIT-6, -6.22 days for NDM, -15.75 for AMI, and -1.71 for PI. Generally, the effect at 6- and 12-months increased slightly and gradually. The MMD/MHD response rates revealed that approximately one-third of patients exhibited a response greater than 30%, while one-sixth demonstrated a response exceeding 50%. Additionally, 3-4% of patients achieved a response rate of 100%. Adverse event rates were 0.34 and 0.43 at 6- and 12-months, respectively.
CONCLUSIONS: This study provides strong evidence of the effectiveness and safety of erenumab in the real world; to our knowledge, this is the first real-world meta-analysis specific to erenumab. Erenumab represents a solid therapeutic option for physicians.
摘要:
背景:偏头痛是一种常见且致残的原发性头痛障碍。几种靶向降钙素基因相关肽(CGRP)的药物,例如erenumab(一种抗CGRP受体mAb),是最近开发的。然而,erenumab的真实世界效应尚不清楚.
目的:评估erenumab在现实世界中降低偏头痛强度和频率的临床有效性和安全性。
方法:对PubMed的系统搜索,Scopus,WebofScience和Cochrane图书馆从成立到2023年12月进行。估计erenumab对每月偏头痛天数(MMD)的真实世界影响的研究,每月头痛天数(MHD),头痛冲击试验(HIT-6),用药天数(NDM),急性月摄入量(AMI),包括疼痛强度(PI)和安全性结局.进行比例或平均差异的荟萃分析。
结果:纳入了53项研究。3个月时,MMD的效果为-7.18天,-MHD为6.89天,HIT-6为-6.97,NDM为-6.22天,-AMI的15.75,PI为-1.71。一般来说,在6个月和12个月时的效果逐渐增加。MMD/MHD反应率显示,大约三分之一的患者表现出超过30%的反应,而六分之一的人表现出超过50%的反应。此外,3-4%的患者达到100%的反应率。6个月和12个月的不良事件发生率分别为0.34和0.43,分别。
结论:这项研究为erenumab在现实世界中的有效性和安全性提供了强有力的证据;据我们所知,这是erenumab特有的首个真实世界荟萃分析.Erenumab代表了医生的可靠治疗选择。
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