Migraine remains a complex and often debilitating neurologic disorder, extending far beyond episodic head pain to encompass a wide range of symptoms that can disrupt daily functioning, cognition, and overall quality of life. For many patients, particularly those with chronic migraine, the cumulative burden is substantial, characterized by frequent headache days, impaired productivity, and persistent disability.
Key Points
- INFUSE is a 12-month, prospective, real-world study in patients with migraine who previously failed ≥1 CGRP-targeted therapy
- 50% of participants had failed ≥3 prior CGRP-targeted treatments, reflecting a highly refractory population
- 60% of patients reported improvement by day 7, increasing to 76% at 6 months (PGIC)
- Reductions in headache days and increases in patient-reported “good days” were observed at 3 and 6 months
- Intravenous eptinezumab reaches 100% bioavailability within ~30 minutes, supporting rapid onset of effect
Despite an expanding therapeutic landscape, a meaningful subset of patients continues to cycle through multiple treatment options without achieving adequate relief, underscoring the need for therapies that act quickly, address patient-prioritized outcomes, and demonstrate effectiveness in real-world settings.
Eptinezumab became the first FDA-approved intravenous (IV) treatment for migraine prevention in February 2020 based on the phase 3 PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine trials.
At the 2026 American Academy of Neurology Annual Meeting, new findings from the INFUSE study evaluating eptinezumab (Vyepti) offered insight into 6-month outcomes in a particularly treatment-experienced population. A 12-month, prospective, non-interventional, real-world study, INFUSE enrolled patients with migraine who had already failed ≥ 1 calcitonin gene-related peptide (CGRP)-targeted therapies, many of whom had cycled through multiple such options prior to initiating eptinezumab.
Baseline characteristics of the study population highlight the severity of disease burden. In an interview with Patient Care Online, Amaal Starling, MD, a neurologist and an Associate Professor of Neurology in the Mayo Clinic College of Medicine and Science, noted most participants had chronic migraine, with approximately 20 headache days per month and high disability scores, including Migraine Disability Assessment (MIDAS) scores exceeding 100. Additionally, more than half of participants had previously failed ≥ 3 CGRP-targeted therapies, positioning INFUSE as a reflection of a highly refractory patient population.
