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
{"title":"A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II).","authors":"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","doi":"10.1007/s00415-025-13095-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Primary endpoint: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":16558,"journal":{"name":"Journal of Neurology","volume":"272 6","pages":"382"},"PeriodicalIF":4.8000,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058817/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00415-025-13095-z","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.