Scuteri Damiana, Pagliaro Martina, Iannacchero Rosario, Trimboli Michele, Lawrence Gary W, Bagetta Giacinto, Corasaniti Maria Tiziana
Department of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, Rende, Italy.
J Headache Pain. 2025 Jul 14;26(1):159. doi: 10.1186/s10194-025-02106-z.
Migraine, a spectrum of episodic headache disorders common in the global population, may evolve into a very debilitating chronic condition, usually underdiagnosed, poorly recognized and difficult to manage. Neurotransmission in the trigeminovascular sensory nervous system, particularly involving calcitonin gene-related peptide (CGRP), has emerged as a prime therapeutic target for the treatment of chronic migraine. Here we investigated differences in efficacy of eptinezumab (a monoclonal antibody [mAb] targetting CGRP) and onabotulinumtoxinA (an inhibitor of neurotransmitter release) in an Italian real-world setting in which medical medication overuse headache (MOH) is prevalent.
Forty chronic migraine patients refractory to standard treatments were observed, of which 15 were over 50 years old, and 4 exceeded 65 years. The primary endpoint of efficacy was reduction of monthly migraine days (MMDs) collected at two time points: after 3 and 6 months, respectively. The secondary endpoints, also performed after 3 and 6 months, include reduction of monthly headache days (MHDs), days in need of rescue medications, diminished pain intensity and on disability measured as Migraine Disability Assessment (MIDAS). Statistical differences were analysed using two-way analysis of variance with measurement repetition tests (Two-way RM ANOVA, followed by Bonferroni or Sidak test).
Both eptinezumab and onabotulinumtoxinA demonstrated efficacy at 3 and 6 months, with no statistically significant differences between them for either primary or secondary endpoints. Both treatments had a more pronounced effect on MMDs and MHDs than on the reduction of intensity and disability, and reduced the need for rescue medications at 3 and 6 months. After 3 months, onabotulinumtoxinA displays a trend to reduce the need to rescue medication in a higher number of patients compared to eptinezumab.
OnabotulinumtoxinA was as effective as eptinezumab for chronic migraine prophylaxis according to both primary and secondary endpoints and, therefore, is useful as an alternative or adjunct therapy to mAbs or gepants.
偏头痛是全球人群中常见的一系列发作性头痛疾病,可能会演变成一种非常使人衰弱的慢性疾病,通常诊断不足、认识不足且难以治疗。三叉神经血管感觉神经系统中的神经传递,特别是涉及降钙素基因相关肽(CGRP)的传递,已成为治疗慢性偏头痛的主要治疗靶点。在此,我们在意大利一个药物过度使用性头痛(MOH)普遍存在的真实世界环境中,研究了eptinezumab(一种靶向CGRP的单克隆抗体[mAb])和A型肉毒毒素(一种神经递质释放抑制剂)疗效的差异。
观察了40例对标准治疗无效的慢性偏头痛患者,其中15例年龄超过50岁,4例超过65岁。疗效的主要终点是在两个时间点收集的每月偏头痛天数(MMD)减少:分别在3个月和6个月后。次要终点也在3个月和6个月后进行,包括每月头痛天数(MHD)减少、需要急救药物的天数、疼痛强度减轻以及以偏头痛残疾评估(MIDAS)衡量的残疾程度。使用双向方差分析和测量重复检验(双向重复测量方差分析,随后进行Bonferroni或Sidak检验)分析统计差异。
eptinezumab和A型肉毒毒素在3个月和6个月时均显示出疗效,在主要或次要终点方面两者之间无统计学显著差异。两种治疗对MMD和MHD的影响比对强度和残疾程度降低的影响更为显著,并在3个月和6个月时减少了对急救药物的需求。3个月后,与eptinezumab相比,A型肉毒毒素在更多患者中显示出减少急救药物需求的趋势。
根据主要和次要终点,A型肉毒毒素在预防慢性偏头痛方面与eptinezumab一样有效,因此,可作为mAb或 gepants的替代或辅助治疗方法。