A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II).

IF 4.8 2区 医学 Q1 CLINICAL NEUROLOGY
Piero Barbanti, Cinzia Aurilia, Gabriella Egeo, Alberto Doretti, Florindo d'Onofrio, Paola Scatena, Steno Rinalduzzi, Luisa Vinciguerra, Mattia Sansone, Rosario Vecchio, Valeria Drago, Giovanna Viticchi, Marco Bartolini, Angelo Ranieri, Monica Bandettini di Poggio, Francesco Baldisseri, Davide Mascarella, Fabio Brusaferri, Luigi Caputi, Stefano Messina, Massimo Autunno, Alessandro Valenza, Bianca Orlando, Marisa Distefano, Laura Borrello, Francesca Pistoia, Cecilia Camarda, Gennaro Saporito, Giacomo Querzola, Paola Torelli, Antonio Salerno, Francesca Gragnani, Barbara Petolicchio, Antonio Carnevale, Roberta Messina, Massimo Filippi, Sofia Tavani, Giulia Fiorentini, Stefano Bonassi, Sabina Cevoli, Alice Mannocci
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引用次数: 0

Abstract

Introduction: We evaluated the effectiveness, tolerability, and safety of eptinezumab in preventing high-frequency episodic migraine (HFEM) and chronic migraine (CM) over 24 weeks in real-world. We also assessed its impact during the first treatment week, in patients failing monoclonal antibodies targeting the calcitonin gene-related peptide (anti-CGRP mAbs), and the effects of dose escalation to 300 mg in patients requiring enhanced control.

Methods: EMBRACE II is a multicenter (n = 22), prospective, 24-week, real-world study involving consecutive patients with HFEM or CM who had failed > 3 preventive treatments. Eptinezumab (100 mg, with the option for escalation to 300 mg at week 12) was administered quarterly.

Primary endpoint: change in monthly migraine days (MMD), for HFEM or monthly headache days (MHD), for CM, between weeks 21-24 and baseline. Secondary endpoints: changes in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), Migraine Disability Assessment Scale (MIDAS), Migraine Interictal Burden Scale (MIBS-4), and responder rates.

Results: Of the 215 participants who had received ≥ 1 eptinezumab dose, 74 were treated for ≥ 24 weeks and considered for effectiveness analysis. Eptinezumab significantly (p < 0.001) reduced MMD/MHD (- 10.5), MAI (- 15.6), NRS (- 2.2), HIT-6 (- 9.9), MIDAS (- 48.7), and MIBS-4 (- 4.3). ≥ 50% responders were 69%, ≥ 75% responders 39.2%, and 100% responders 4.1%. Comparing the first week with the last baseline week, a significant reduction in migraine days was observed (- 3.7; p < 0.001). Significant improvements were seen in patients failing anti-CGRP mAbs (32.4%) and in those escalating to 300 mg (33.8%). Half of the subjects reported being "very much improved" or "much improved". The adverse events were infrequent (2.8%).

Conclusions: This real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients with multiple therapeutic failures (including anti-CGRP mAbs). One-third of patients escalated to 300 mg at week 12, achieving further significant migraine-related disability reduction.

一项关于eptinezumab在偏头痛预防中的有效性和安全性的24周前瞻性、多中心、真实世界研究(EMBRACE II)。
我们在现实世界中评估了eptinezumab在24周内预防高频发作性偏头痛(HFEM)和慢性偏头痛(CM)的有效性、耐受性和安全性。我们还评估了其在第一个治疗周的影响,针对降钙素基因相关肽(抗cgrp单克隆抗体)单克隆抗体失败的患者,以及剂量增加到300 mg对需要加强控制的患者的影响。方法:EMBRACE II是一项多中心(n = 22)、前瞻性、24周、真实世界的研究,涉及连续的HFEM或CM患者,这些患者均接受了>3预防治疗失败。Eptinezumab (100mg,可选择在第12周增加到300mg)每季度给药一次。主要终点:21-24周与基线相比,HFEM患者每月偏头痛天数(MMD)或CM患者每月头痛天数(MHD)的变化。次要终点:每月止痛药摄入量(MAI)、数值评定量表(NRS)、头痛影响测试(HIT-6)、偏头痛残疾评估量表(MIDAS)、偏头痛间期负担量表(MIBS-4)和应答率的变化。结果:在接受≥1剂量eptinezumab治疗的215名参与者中,74名患者治疗≥24周,并考虑进行有效性分析。结论:这项真实世界的研究证明,24周的Eptinezumab治疗对多重治疗失败(包括抗cgrp单克隆抗体)的偏头痛患者迅速有效且耐受性良好。三分之一的患者在第12周增加到300mg,进一步显著减少偏头痛相关的残疾。
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来源期刊
Journal of Neurology
Journal of Neurology 医学-临床神经学
CiteScore
10.00
自引率
5.00%
发文量
558
审稿时长
1 months
期刊介绍: The Journal of Neurology is an international peer-reviewed journal which provides a source for publishing original communications and reviews on clinical neurology covering the whole field. In addition, Letters to the Editors serve as a forum for clinical cases and the exchange of ideas which highlight important new findings. A section on Neurological progress serves to summarise the major findings in certain fields of neurology. Commentaries on new developments in clinical neuroscience, which may be commissioned or submitted, are published as editorials. Every neurologist interested in the current diagnosis and treatment of neurological disorders needs access to the information contained in this valuable journal.
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