Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.
New England Institute for Neurology and Headache, Stamford, CT, USA.
Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18.
This post hoc subgroup analysis evaluated the efficacy and safety of eptinezumab for migraine prevention in patients with migraine and self-reported aura.
PROMISE-1 (NCT02559895; episodic migraine) and PROMISE-2 (NCT02974153; chronic migraine) were randomized, double-blind, placebo-controlled trials that evaluated eptinezumab for migraine prevention. In both studies, the primary outcome was the mean change from baseline in monthly migraine days over Weeks 1-12. Patients in this analysis included those who self-reported migraine with aura at screening.
Of patients with episodic migraine, ∼75% reported a history of aura at screening; of patients with chronic migraine, ∼35% reported a history of aura. Changes in monthly migraine days over Weeks 1-12 were -4.0 (100 mg) and -4.2 (300 mg) with eptinezumab versus -3.1 with placebo in patients with episodic migraine with aura, and were -7.1 (100 mg) and -7.6 (300 mg) with eptinezumab versus -6.0 with placebo in patients with chronic migraine with aura. Treatment-emergent adverse events were reported by 56.0% (100 mg), 57.4% (300 mg), and 55.4% (placebo) of patients.
The preventive migraine efficacy of eptinezumab in patients in the PROMISE studies who self-reported aura was comparable to the overall study populations, demonstrating a similarly favorable safety and tolerability profile.Trial registration: ClinicalTrials.gov Identifiers: NCT02559895 and NCT02974153.
本事后亚组分析评估了eptinezumab 用于有先兆偏头痛患者偏头痛预防的疗效和安全性。
PROMISE-1（NCT02559895；发作性偏头痛）和 PROMISE-2（NCT02974153；慢性偏头痛）为随机、双盲、安慰剂对照试验，旨在评估 eptinezumab 用于偏头痛预防。两项研究的主要结局为第 1-12 周期间每月偏头痛天数相对于基线的平均变化。本分析纳入了在筛查时报告有先兆偏头痛的患者。
发作性偏头痛患者中约 75%在筛查时报告有先兆偏头痛病史；慢性偏头痛患者中约 35%报告有先兆偏头痛病史。有先兆偏头痛发作性偏头痛患者中，eptinezumab 治疗组每月偏头痛天数相对于基线的变化为 -4.0（100mg）和 -4.2（300mg），安慰剂组为 -3.1；有先兆偏头痛慢性偏头痛患者中，eptinezumab 治疗组为 -7.1（100mg）和 -7.6（300mg），安慰剂组为 -6.0。有先兆偏头痛发作性偏头痛患者中，分别有 56.0%（100mg）、57.4%（300mg）和 55.4%（安慰剂）报告出现治疗后不良事件。
在 PROMISE 研究中报告有先兆偏头痛的患者中，eptinezumab 的预防性偏头痛疗效与总体研究人群相当，表明具有相似的良好安全性和耐受性。
ClinicalTrials.gov 标识符：NCT02559895 和 NCT02974153。
