OC-14 | Efficacy of eptinezumab during a migraine attack: preliminary data from an Italian multicenter real-world experience (the BEFREE study)

Luisa Fofi,¹ Claudia Altamura,¹ Marilena Marcosano,¹ Alberto Doretti,² Francesca Pistoia,³ Antonio Granato,⁴ Simona Guerzoni,⁵ Michele Trimboli,⁶ Licia Grazzi,⁷ Danilo Antonio Montisano,⁷ Gianluca Avino,⁸ Gabriele Sebastianelli,⁹ Carla Fasano,¹⁰ Elisa Maria Piella,¹¹ Nicoletta Brunelli,¹ Luigi Francesco Iannone,^5,12 Fabrizio Vernieri¹ on behalf of the Italian Headache Registry (RICe) Study Group | ¹Neurosonology and Headache Unit, Fondazione Policlinico Campus Bio-Medico, Rome; ²IRCCS Istituto Auxologico Italiano - Department of Neurology and Laboratory of Neuroscience - Milan; ³University of L’Aquila; ⁴Headache Center, Neurology Clinic, University of Trieste, University Hospital of Trieste; ⁵AOU Policlinico di Modena; ⁶Azienda Ospedaliera-universitaria "Renato Dulbecco", Catanzaro; ⁷Headache Center, Neuroalgology Dpt, IRCCS Foundation "Carlo Besta" Neurological Institute, Milan; ⁸SOC Neurologia, Ospedale Santo Stefano, USL Toscana Centro, Prato; ⁹La Sapienza University of Rome Polo Pontino, Latina; ¹⁰Headache and Cerebrovascular Diseases Center, Neurology Unit 2, Careggi University Hospital, Florence; ¹¹Department of Neuroscience “Rita Levi Montalcini”, University of Turin; ¹²Università di Modena e Reggio Emilia, Italy

Background: Eptinezumab is the intravenous anti-calcitonin gene-related peptide (CGRP) monoclonal antibody approved for the preventive treatment of migraine. In the RELIEF study, eptinezumab significantly shortened time to headache pain freedom and to absence of most bothersome symptom when administered during a migraine attack, 0.5–1 hour following the start of infusion. The aim of this study was to observe the possible resolution of a migraine attack during eptinezumab infusion in a real-world setting, particularly exploring the first 30 minutes.

Methods: This is an ongoing Italian observational prospective study; we included data from November 2024 to May 2025. Patients with episodic (EM) and chronic migraine (CM) receiving eptinezumab 100 mg or 300 mg during a migraine attack were enrolled. Eptinezumab was administered within 1–12 h of onset of the qualifying migraine. Rescue medication was not allowed in the 24-h period prior to receiving study treatment or within 2 h of infusion start. Migraine features, monthly migraine days (MMDs), number of acute medications, past preventive medication failures, medication overuse (MO) were collected at baseline. Headache pain intensity (NRS 0-10 scale), associated symptoms and acute medications were recorded at different timepoints after infusion start: 10 minutes (T10), 20 minutes (T20), 30 minutes (T30), 1h, 1.5h, 2.5h, 3h, 3.5h, and from 4h to 48 h.

Results: We enrolled 31 patients, mainly females (27, 87%) with a mean age of 43.1+2.7 years; 68% of patients had CM and 62% MO. At baseline the mean MMDs were 22.7+6.8 and 35.5% of patients took standard oral preventive treatments. The NRS score (baseline 6.2+1.9) progressively reduced at different timepoints, with the lowest value after 12 hours after the infusion (2.9+3.7). In the first 30 minutes of the infusion, NRS score significantly varied from T0 to T10 (p=0.011) and from 10 to 20 minutes (p=0.004). Photophobia was significantly lower at T10 (p=0.025) and at T20 (p=0.08) compared to baseline. The presence of phonophobia was significantly lower comparing baseline to T20 (p=0.005) and T30 (p=0.005). Osmophobia was also significant comparing baseline to T30 (p=0.046). Pain freedom was reported by 6.5% of patients at T10, 20% T20, 13.3% T30, 16.7% 1h, 19% 2h, 58% 12h, 35.3% 24 h and 31.3% 48 h. The achievement of pain freedom from T10 to T20 and from 4h to 12h was significant (p=0.046).

Conclusion: During the first 30 minutes of the infusion, eptinezumab demonstrated to induce a rapid resolution of migraine pain intensity and associated symptoms, suggesting a peripheral site of pharmacological action for CGRP blockade.