Root Shane, Ahn Kevin, Kirsch Jack, Hoskin Justin L
Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.
University of Arizona School of Medicine, Phoenix, AZ, USA.
Neuropsychiatr Dis Treat. 2023 Feb 20;19:391-401. doi: 10.2147/NDT.S371686. eCollection 2023.
Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) were the first class of medication specifically developed for the prevention of migraine. Fremanezumab is one of four CGRP mAbs currently available and is approved by the US Food and Drug Administration (FDA) for the preventative treatment of episodic and chronic migraines. This narrative review summarizes the history of fremanezumab development, the trials that led to its approval, and the later studies published evaluating its tolerability and efficacy. Evidence of fremanezumab for clinically significant efficacy and tolerability in patients with chronic migraine is especially important when considering the high level of disability, lower quality of life scores, and higher levels of health-care utilization associated with this condition. Multiple clinical trials demonstrated superiority of fremanezumab over placebo in terms of efficacy while demonstrating good tolerability. Treatment-related adverse reactions did not differ significantly compared to placebo and dropout rates were minimal. The most commonly observed treatment-related adverse reaction was mild-to-moderate injection site reaction, described as erythema, pain, induration, or swelling at the injection site.
降钙素基因相关肽（CGRP）单克隆抗体（mAbs）是首批专门开发用于预防偏头痛的药物。夫瑞那单抗是目前可用的四种CGRP单克隆抗体之一，已获得美国食品药品监督管理局（FDA）批准，用于发作性和慢性偏头痛的预防性治疗。本叙述性综述总结了夫瑞那单抗的研发历史、促成其获批的试验，以及后来发表的评估其耐受性和疗效的研究。考虑到慢性偏头痛患者的高度残疾、较低的生活质量评分以及较高的医疗保健利用率，夫瑞那单抗对慢性偏头痛患者具有临床显著疗效和耐受性的证据尤为重要。多项临床试验表明，夫瑞那单抗在疗效方面优于安慰剂，同时耐受性良好。与安慰剂相比，治疗相关不良反应无显著差异，脱落率极低。最常观察到的治疗相关不良反应是轻至中度注射部位反应，表现为注射部位的红斑、疼痛、硬结或肿胀。
