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Introduction <p>We evaluated the effectiveness, tolerability, and safety of eptinezumab in preventing high-frequency episodic migraine (HFEM) and chronic migraine (CM) over 24&#xa0;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&#xa0;mg in patients requiring enhanced control.</p> Methods <p>EMBRACE II is a multicenter (<i>n</i> = 22), prospective, 24-week, real-world study involving consecutive patients with HFEM or CM who had failed &gt; 3 preventive treatments. Eptinezumab (100&#xa0;mg, with the option for escalation to 300&#xa0;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.</p> Results <p>Of the 215 participants who had received ≥ 1 eptinezumab dose, 74 were treated for ≥ 24&#xa0;weeks and considered for effectiveness analysis. Eptinezumab significantly (<i>p</i> &lt; 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%.</p> <p>Comparing the first week with the last baseline week, a significant reduction in migraine days was observed (−&#xa0;3.7; <i>p</i> &lt; 0.001). Significant improvements were seen in patients failing anti-CGRP mAbs (32.4%) and in those escalating to 300&#xa0;mg (33.8%).</p> <p>Half of the subjects reported being “very much improved” or “much improved”. The adverse events were infrequent (2.8%).</p> Conclusions <p>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&#xa0;mg at week 12, achieving further significant migraine-related disability reduction.</p>

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

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  • 发表日期：

    2025年5月7日

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  • 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,
  • Marco Aguggia,
  • Maria Albanese,
  • Gennaro Alfieri,
  • Diletta Alivernini,
  • Raffaella Ardau,
  • Maria Letizia Bartolozzi,
  • Maria Carmela Bloise,
  • Francesco Bono,
  • Simone Braca,
  • Antonio Bruno,
  • Stefano Caproni,
  • Ilaria Cetta,
  • Alessandra Cherchi,
  • Bruno Colombo,
  • Eleonora Colombo,
  • Alfonso Coppola,
  • Domenico Cosenza,
  • Francesca Cortese,
  • Matteo De Bartolo,
  • Laura Di Clemente,
  • Roberto De Simone,
  • Arianna Deidda,
  • Alessandra Del Bene,
  • Gianluca Demirtzidis,
  • Alfonsina Di Summa,
  • Valentina Favoni,
  • Ludovica Ferraù,
  • Isabella Ferdinanda Pestalozza,
  • Cinzia Finocchi,
  • Fabio Frediani,
  • Annalisa Gai,
  • Rosario Grugno,
  • Martina Guarinoni,
  • Elisabetta Iannaccone,
  • Giovanni Idone,
  • Vincenzo Laterza,
  • Riccardo Lo Presti,
  • Luca Lombardi,
  • Irene Madonia,
  • Andrea Mancioli,
  • Sara Matignaro,
  • Silvia Nizzoli,
  • Matteo Paolucci,
  • Maristella Piccininni,
  • Pietro Querzani,
  • Simone Quintana,
  • Micaela Robotti,
  • Pamela Rosettani,
  • Marco Russo,
  • Sergio Salvemini,
  • Giuliano Sette,
  • Gabriele Sixt,
  • Michela Sforza,
  • Martina Sodano,
  • Giorgio Spano,
  • Maria Erminia Stochino,
  • Silvia Strumia,
  • Denise Tedeschi,
  • Rossana Terlizzi,
  • Valentina Teresi,
  • Daniela Ungaro,
  • Fabio Valguarnera,
  • Gianluca Vita,
  • Laura Zanandrea,
  • Maurizio Zucco

摘要

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.