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.
A 24-week prospective, multicenter, real-world study on eptinezumab’s effectiveness and safety in migraine prevention (EMBRACE II) / Barbanti, Piero; Aurilia, Cinzia; Egeo, Gabriella; Doretti, Alberto; D'Onofrio, Florindo; Scatena, Paola; Rinalduzzi, Steno; Vinciguerra, Luisa; Sansone, Mattia; Vecchio, Rosario; Drago, Valeria; Viticchi, Giovanna; Bartolini, Marco; Ranieri, Angelo; Bandettini di Poggio, Monica; Baldisseri, Francesco; Mascarella, Davide; Brusaferri, Fabio; Caputi, Luigi; Messina, Stefano; Autunno, Massimo; Valenza, Alessandro; Orlando, Bianca; Distefano, Marisa; Borrello, Laura; Pistoia, Francesca; Camarda, Cecilia; Saporito, Gennaro; Querzola, Giacomo; Torelli, Paola; Salerno, Antonio; Gragnani, Francesca; Petolicchio, Barbara; Carnevale, Antonio; Messina, Roberta; Filippi, Massimo; Tavani, Sofia; Fiorentini, Giulia; Bonassi, Stefano; Cevoli, Sabina; Mannocci, Alice; Null, Null; Aguggia, Marco; Albanese, Maria; Alfieri, Gennaro; Alivernini, Diletta; Ardau, Raffaella; Bartolozzi, Maria Letizia; Bloise, Maria Carmela; Bono, Francesco; Braca, Simone; Bruno, Antonio; Caproni, Stefano; Cetta, Ilaria; Cherchi, Alessandra; Colombo, Bruno; Colombo, Eleonora; Coppola, Alfonso; Cosenza, Domenico; Cortese, Francesca; De Bartolo, Matteo; Di Clemente, Laura; De Simone, Roberto; Deidda, Arianna; Del Bene, Alessandra; Demirtzidis, Gianluca; Di Summa, Alfonsina; Favoni, Valentina; Ferraù, Ludovica; Pestalozza, Isabella Ferdinanda; Finocchi, Cinzia; Frediani, Fabio; Gai, Annalisa; Grugno, Rosario; Guarinoni, Martina; Iannaccone, Elisabetta; Idone, Giovanni; Laterza, Vincenzo; Presti, Riccardo Lo; Lombardi, Luca; Madonia, Irene; Mancioli, Andrea; Matignaro, Sara; Nizzoli, Silvia; Paolucci, Matteo; Piccininni, Maristella; Querzani, Pietro; Quintana, Simone; Robotti, Micaela; Rosettani, Pamela; Russo, Marco; Salvemini, Sergio; Sette, Giuliano; Sixt, Gabriele; Sforza, Michela; Sodano, Martina; Spano, Giorgio; Stochino, Maria Erminia; Strumia, Silvia; Tedeschi, Denise; Terlizzi, Rossana; Teresi, Valentina; Ungaro, Daniela; Valguarnera, Fabio; Vita, Gianluca; Zanandrea, Laura; Zucco, Maurizio. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 272:6(2025). [10.1007/s00415-025-13095-z]
A 24-week prospective, multicenter, real-world study on eptinezumab’s effectiveness and safety in migraine prevention (EMBRACE II)
Messina, Roberta;Filippi, Massimo;Cetta, Ilaria;Zanandrea, Laura;
2025-01-01
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.| File | Dimensione | Formato | |
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