Gantenbein Andreas R, Kamm Christian P, Schankin Christoph J, Zecca Chiara, Zieglgänsberger Dominik, Pohl Heiko, Ryvlin Philippe, Agosti Reto, Viceic Dragana, Parzini Catherine, Kulartz-Schank Monika, Arzt Michael E
Department of Neurology and Neurorehabilitation, Zurzach Care, Bad Zurzach, Switzerland.
Department of Neurology, University Hospital Zurich, Zurich, Switzerland.
Headache. 2025 Jul-Aug;65(7):1134-1147. doi: 10.1111/head.14943. Epub 2025 Apr 30.
OBJECTIVES/BACKGROUND: This prospective, multicenter, noninterventional cohort study evaluated the impact of erenumab on the quality of life and migraine-related impairment of adult patients with migraine, as well as the drug's tolerability in a real-world setting over 2 years. Erenumab, a fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland for prophylactic treatment of adult patients with migraine in July 2018.
Adult patients with chronic or episodic migraine who received erenumab treatment as per Swiss label were enrolled from 19 sites across Switzerland between February 2019 and November 2022. Inclusion criteria were defined as the following: a migraine diagnosis per International Classification of Headache Disorders, 3rd edition, patient written informed consent, and adherence to Swiss label guidelines. Exclusion criteria were concomitant use of other investigational drugs or prior treatment with erenumab or any CGRP (receptor)-based therapy. Retrospective and prospective data from patients were collected over 24 months using patient-reported outcome questionnaires (Headache Impact Test-6 [HIT-6], modified Migraine Disability Assessment [mMIDAS], Impact of Migraine on Partners and Adolescent Children [IMPAC]), patient diaries, and medical charts to track migraine days, medication use, and health care utilization. Swiss regulations required patients to maintain migraine diaries 3 months before and during erenumab therapy to record migraine and acute medication days.
A total of 173 patients (84.9% females) were enrolled who had an average age of 44.2 years. Of these, 54.3% were diagnosed with episodic migraine and 45.7% with chronic migraine. At baseline, the participants scored 65.9 ± 4.9 (mean ± SD) on HIT-6. A total of 85.5% had grade III-IV on the mMIDAS and 87% had grade III-IV in IMPAC. Patients reported 16.5 ± 7.2 monthly migraine days and 11.5 ± 7.0 acute migraine-specific medication days per month. After 24 months, the mean HIT-6 score had decreased by 8.1 ± 8.6, mean mMIDAS by 16.6 ± 21.2, monthly migraine days by 8.8 ± 7.6, and mean acute migraine-specific medication days by 5.2 ± 6.8 (all p < 0.001). Reductions of IMPAC by 6.5 ± 6.6 (p < 0.001) showed the beneficial impact of erenumab treatment on the patients' family burden attributed to migraine. Overall, 84 of 173 patients (48.6%) had at least one adverse event and 61 of 173 patients (35.3%) had at least one adverse event related to study drug. The safety profile was in line with the pivotal studies, and no serious adverse events were regarded as being related to erenumab.
Overall, erenumab treatment significantly reduced the burden of migraine, leading to improved quality of life for patients and their families over a treatment period of 2 years.
目的/背景:这项前瞻性、多中心、非干预性队列研究评估了erenumab对偏头痛成年患者生活质量和偏头痛相关损害的影响,以及该药物在现实环境中2年的耐受性。Erenumab是一种靶向降钙素基因相关肽(CGRP)受体的全人单克隆抗体,于2018年7月在瑞士获得许可,用于偏头痛成年患者的预防性治疗。
2019年2月至2022年11月期间,从瑞士各地的19个地点招募了按照瑞士标签接受erenumab治疗的慢性或发作性偏头痛成年患者。纳入标准定义如下:根据《国际头痛疾病分类》第三版诊断为偏头痛,患者书面知情同意,并遵守瑞士标签指南。排除标准为同时使用其他研究药物或先前接受过erenumab或任何基于CGRP(受体)的治疗。通过患者报告结局问卷(头痛影响测试-6 [HIT-6]、改良偏头痛残疾评估 [mMIDAS]、偏头痛对伴侣和青少年子女的影响 [IMPAC])、患者日记和病历收集患者24个月的回顾性和前瞻性数据,以跟踪偏头痛天数、药物使用情况和医疗保健利用情况。瑞士法规要求患者在erenumab治疗前3个月和治疗期间记录偏头痛日记,以记录偏头痛和急性用药天数。
共纳入173例患者(84.9% 为女性),平均年龄44.2岁。其中,54.3% 被诊断为发作性偏头痛,45.7% 被诊断为慢性偏头痛。基线时,参与者在HIT-6上的评分为65.9±4.9(平均值±标准差)。共有85.5% 的患者在mMIDAS上为III-IV级,87% 的患者在IMPAC上为III-IV级。患者报告每月偏头痛天数为16.5±7.2天,每月急性偏头痛特异性用药天数为11.5±7.0天。24个月后,平均HIT-6评分降低了8.1±8.6,平均mMIDAS降低了16.6±21.2,每月偏头痛天数减少了8.8±7.6,平均急性偏头痛特异性用药天数减少了5.2±6.8(所有p<0.001)。IMPAC降低了6.5±6.6(p<0.001),表明erenumab治疗对偏头痛给患者家庭带来的负担有有益影响。总体而言,173例患者中有84例(48.6%)至少发生了一次不良事件,173例患者中有61例(35.3%)至少发生了一次与研究药物相关的不良事件。安全性概况与关键研究一致,没有严重不良事件被认为与erenumab有关。
总体而言,erenumab治疗显著减轻了偏头痛负担,在2年的治疗期内改善了患者及其家人的生活质量。