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, P.; Aurilia, C.; Egeo, G.; Doretti, A.; D'Onofrio, F.; Scatena, P.; Rinalduzzi, S.; Vinciguerra, L.; Sansone, M.; Vecchio, R.; Drago, V.; Viticchi, G.; Bartolini, M.; Ranieri, A.; Bandettini Di Poggio, M.; Baldisseri, F.; Mascarella, D.; Brusaferri, F.; Caputi, L.; Messina, S.; Autunno, M.; Valenza, A.; Orlando, B.; Distefano, M.; Borrello, L.; Pistoia, F.; Camarda, C.; Saporito, G.; Querzola, G.; Torelli, P.; Salerno, A.; Gragnani, F.; Petolicchio, B.; Carnevale, A.; Messina, R.; Filippi, M.; Tavani, S.; Fiorentini, G.; Bonassi, S.; Cevoli, S.; Mannocci, A.; Zucco, M.; Zanandrea, L.; Vita, G.; Valguarnera, F.; Ungaro, D.; Teresi, V.; Terlizzi, R.; Tedeschi, D.; Strumia, S.; Stochino, M. E.; Spano, G.; Sodano, M.; Sforza, M.; Sixt, G.; Sette, G.; Salvemini, S.; Russo, M.; Rosettani, P.; Robotti, M.; Quintana, S.; Querzani, P.; Piccininni, M.; Paolucci, M.; Nizzoli, S.; Matignaro, S.; Mancioli, A.; Madonia, I.; Lombardi, L.; Presti, R. L.; Laterza, V.; Idone, G.; Iannaccone, E.; Guarinoni, M.; Grugno, R.; Gai, A.; Frediani, F.; Finocchi, C.; Pestalozza, I. F.; Ferrau, L.; Favoni, V.; Di Summa, A.; Demirtzidis, G.; Del Bene, A.; Deidda, A.; De Simone, R.; Di Clemente, L.; De Bartolo, M.; Cortese, F.; Cosenza, D.; Coppola, A.; Colombo, E.; Colombo, B.; Cherchi, A.; Cetta, I.; Caproni, S.; Bruno, A.; Braca, S.; Bono, F.; Bloise, M. C.; Bartolozzi, M. L.; Ardau, R.; Alivernini, D.; Alfieri, G.; Albanese, M.; Aguggia, M.. - 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)
Bartolini M.;Messina S.;Distefano M.;Borrello L.;Torelli P.;Tavani S.;Fiorentini G.;Vita G.;Tedeschi D.;Quintana S.;Guarinoni M.;Favoni V.;De Simone R.;Bono F.;Albanese M.;
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
