New real-world 6-month results from the INFUSE study presented at the AAN 2026 meeting, showing the importance of evaluating the broad burden of migraine beyond headache and migraine frequency – Lundbeck
H. Lundbeck A/S y presented new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency. Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied. These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after eptinezumab treatment.
“Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe ‘brain fog’ associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life,” said INFUSE study author Dr. Amaal Starling, Neurologist, Mayo Clinic. “The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting eptinezumab. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes.”
Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline. Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with eptinezumab. Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of eptinezumab) compared to baseline, with marked improvements observed as early as Day 7 post-treatment.
Additional eptinezumab data being presented at AAN are:
- P10 15-006: “Real-World Effectiveness of Eptinezumab in Patients in Whom ≥1 Prior anti-CGRP Preventive Treatment had Failed: 6-Month Results for an Ongoing Prospective Study”
- P10 15-001: “Eptinezumab’s Effect on Interictal Periods and Quality of Life in Participants with Migraine for Whom 2–4 Prior Preventive Treatments had Failed”
About INFUSE study
The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of IV eptinezumab (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. The primary outcome was percent of patients with “much” or “very much” improved on the 7-point PGIC scale (“very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse”). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined “good days”. INFUSE did not collect safety data but these data are reported via the established safety reporting channels.
