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.
The 6-month analysis focused on patient-centered outcomes, with particular emphasis on patient-reported measures. The primary endpoint, Patient Global Impression of Change (PGIC), captured patients’ overall perception of improvement following treatment initiation. Results demonstrated that 60% of patients reported improvement as early as day 7, increasing to 64% at 3 months and 76% at 6 months, suggesting not only sustained benefit but also a rapid onset of effect.
Additional outcomes reinforced these results, with reductions in headache frequency observed at both 3 and 6 months based on MIDAS-derived headache day data. Patients also reported an increase in “good days,” a subjective but meaningful measure reflecting days with minimal or manageable symptoms.
Starling noted eptinezumab’s pharmacokinetic profile may help explain the early and sustained improvements observed. As the only intravenously administered CGRP-targeted therapy, it achieves 100% bioavailability within approximately 30 minutes of infusion, enabling rapid systemic exposure. This mechanism aligns with the early improvements reported in the study, including benefits observed within the first week of treatment.
Beyond traditional efficacy measures, the INFUSE analysis also incorporated data on migraine-related cognitive symptoms, reflecting growing recognition of cognitive dysfunction as a key component of migraine burden. According to accompanying data presented at the meeting, patients experienced real-world improvements in these symptoms over time, further supporting the broader impact of treatment.
Editors’ note: Starling reports relevant disclosures with AbbVie, Allergan, Amgen, Amneal, Axsome Therapeutics, Eli Lilly, Impel, Lundbeck, Med-IQ, Medscape, Miller Medical, Neurolief, Novartis, Pfizer, Salvia, Satsuma, Teva, Theranica, and others.
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