Irimia Pablo, Santos-Lasaosa Sonia, Pozo-Rosich Patricia, Leira Rogelio, Pascual Julio, Láinez José Miguel
Clínica Universidad de Navarra, Pamplona, Spain.
Aragon Institute for Health Research (IIS Aragon), Hospital Clínico Universitario Lozano Blesa, University of Zaragoza, Zaragoza, Spain.
Front Neurol. 2024 Mar 8;15:1355877. doi: 10.3389/fneur.2024.1355877. eCollection 2024.
Eptinezumab, a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), was recently approved in Europe for the prophylactic treatment of migraine in adults who have at least four migraine days a month. Eptinezumab is administered by intravenous infusion every 12 weeks. During recent months, a considerable amount of evidence from eptinezumab trials has been published. The aim of this review is to describe the existing evidence on the tolerability, safety and efficacy of eptinezumab in patients with migraine. Data from randomized (PROMISE-1, PROMISE-2, RELIEF and DELIVER) and open-label (PREVAIL) phase 3 clinical trials have demonstrated the favorable effect of eptinezumab in migraine symptoms from first day of treatment. These studies showed that eptinezumab results in an overall reduction in mean monthly migraine days (MMDs), increases in the ≥50% and ≥ 75% migraine responder rates (MRRs) and improvements in patient-reported outcome measures in both patients with episodic migraine (EM) and with chronic migraine (CM), including patients who failed previous preventive treatments. The RELIEF trial also showed that eptinezumab, within 2 h of administration, reduced headache pain, migraine-associated symptoms and acute medication use when administered during a migraine attack. Eptinezumab benefits manifested as early as day 1 after dosing and with the subsequent doses lasted up to at least 2 years. Treatment-emergent adverse events reported by ≥2% of patients included upper respiratory tract infection and fatigue. Current evidence demonstrates that eptinezumab has a potent, fast-acting, sustained migraine preventive effect in patients with EM and CM. Eptinezumab has also shown to be well tolerated, supporting its use in the treatment of patients with migraine and inclusion in the current migraine therapeutic options.
艾普替奈珠单抗是一种靶向降钙素基因相关肽（CGRP）的单克隆抗体，最近在欧洲被批准用于预防性治疗每月至少有4个偏头痛日的成人偏头痛患者。艾普替奈珠单抗每12周静脉输注一次。近几个月来，已发表了大量来自艾普替奈珠单抗试验的证据。本综述的目的是描述艾普替奈珠单抗在偏头痛患者中的耐受性、安全性和有效性的现有证据。随机（PROMISE - 1、PROMISE - 2、RELIEF和DELIVER）和开放标签（PREVAIL）3期临床试验的数据表明，从治疗第一天起，艾普替奈珠单抗对偏头痛症状就有良好效果。这些研究表明，艾普替奈珠单抗可使平均每月偏头痛天数（MMD）总体减少，≥50%和≥75%偏头痛缓解率（MRR）提高，并且在发作性偏头痛（EM）和慢性偏头痛（CM）患者中，包括之前预防性治疗失败的患者，患者报告的结局指标均有改善。RELIEF试验还表明，在偏头痛发作期间给药时，艾普替奈珠单抗在给药后2小时内可减轻头痛疼痛、偏头痛相关症状并减少急性药物使用。艾普替奈珠单抗的益处最早在给药后第1天就显现出来，后续剂量的效果持续至少2年。≥2%的患者报告的治疗中出现的不良事件包括上呼吸道感染和疲劳。目前的证据表明，艾普替奈珠单抗对EM和CM患者具有强大、快速起效且持续的偏头痛预防作用。艾普替奈珠单抗也已显示出良好的耐受性，支持其用于治疗偏头痛患者并纳入当前的偏头痛治疗选择。
