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Preliminary Italian data show intravenous eptinezumab reduces pain and symptoms in patients with ongoing episodic or chronic migraine attacks.

Preliminary Italian data show intravenous eptinezumab reduces pain and symptoms in patients with ong…
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Key Takeaway
Note preliminary observational data suggesting rapid symptom reduction with eptinezumab in ongoing migraine attacks; confirmatory trials pending.

This preliminary report presents data from an ongoing observational cohort study conducted in an Italian multicenter real-world setting. The study included 31 patients with episodic migraine or chronic migraine who were experiencing an ongoing migraine attack at the time of intervention. No comparator group was included, and the study design precludes causal inference.

Patients received an intravenous infusion of eptinezumab within 1 to 12 hours of the onset of their qualifying migraine attack. Assessments were performed at 10, 20, 30, 60, 90, and 120 minutes during and after the infusion. Results indicated a statistically significant reduction in NRS pain intensity at 10 minutes (p=0.011) and 20 minutes (p=0.004). Frequency of photophobia decreased significantly at 10 minutes (p=0.045), phonophobia at 20 minutes (p=0.014), and osmophobia at 30 minutes (p=0.046). Pain freedom was reported by 6.5% of patients at 10 minutes, increasing to 19.4% at 20 minutes and 29.0% at 30 minutes, before plateauing.

Safety data, including adverse events, serious adverse events, discontinuations, and overall tolerability, were not reported in this preliminary dataset. The study is limited by its small sample size (n=31), observational design, and status as preliminary data from an ongoing trial. These factors restrict the ability to generalize findings or establish long-term safety and efficacy. While this represents the first real-world evidence of rapid symptom relief during the first 30 minutes of infusion for ongoing attacks, clinicians should interpret these results with caution pending confirmation in larger, controlled trials.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedMar 2026
View Original Abstract ↓
IntroductionEptinezumab is an intravenous anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) approved for the prevention of episodic and chronic migraine. We aimed to explore the earliest changes in migraine pain intensity and associated symptoms during the first 30 min of eptinezumab infusion in a real-world setting, particularly when an acute migraine attack was ongoing.MethodsThe BE-FREE study is an ongoing Italian observational, multicenter, independent, real-world, and prospective study. We enrolled patients affected with episodic migraine (EM) and chronic migraine (CM) who were experiencing an ongoing migraine attack. Eptinezumab was administered within 1–12 h of the onset of the qualifying migraine attack. Data collected included monthly migraine days (MMDs), headache pain intensity, the number of monthly acute medications, and the use of concomitant or past standard preventive treatments (SPTs). The Numerical Rating Scale (NRS), associated symptoms, and pain freedom (PF) were recorded before infusion (T0) and at intervals of 10 (T10), 20 (T20), and 30 (T30) min during infusion.ResultsWe enrolled 31 patients (87% female), with a mean age of 43.1 years (SD 2.7); of these, 68% had CM. NRS scores significantly reduced at T10 (p = 0.011) and T20 (p = 0.004). Photophobia was less frequent at T10 (p = 0.045), phonophobia at T20 (p = 0.014), and osmophobia at T30 (p = 0.046) compared with T0. PF was reported by 6.5% of patients at T10, 19.4% at T20, 29.0% at T30, and 19.4% at T60, T90, and T120.DiscussionThe BE-FREE study results, representing the first real-world evidence, demonstrate the rapid effect of eptinezumab during the first 30 min of infusion in patients experiencing an ongoing migraine attack.
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