Migraine and Headache StudiesNicotinic Acetylcholine Receptors StudyNeuroendocrine regulation and behavior

Amaal J. Starling, Stephane Regnier, S. Soni-Brahmbhatt, Susanne F. Awad, S. Grossman, D. Fiore, Sandeep Sharma, Emad Estemalik

2026.5.1Cephalalgia Reports

DOI: 10.1177/25158163261455673

Abstract

Incorporating patient-reported outcomes (PROs) into clinical practice and real-world research is essential to enable a more holistic assessment of treatment effectiveness, beyond migraine frequency alone. Given the number of calcitonin gene-related peptide (CGRP)-targeted treatments available, switching between CGRP-targeted preventive therapies is a common practice. Real-world evidence on switching to intravenous eptinezumab in adults with migraine for whom prior subcutaneous or oral CGRP-targeted preventive therapies failed is limited. The ongoing INFUSE study was designed to evaluate the real-world effectiveness of switching to eptinezumab in US clinical practice among adults with migraine for whom ≥1 prior CGRP-targeted preventive therapy had failed. INFUSE, a real-world, non-interventional study evaluating the effectiveness of eptinezumab in US clinical practice, included adults with migraine for whom ≥1 prior CGRP-targeted preventive therapy had failed and who were newly initiating eptinezumab treatment. PROs were collected electronically. To provide an overall assessment of the change in migraine disease, Patient Global Impression of Change (PGIC) was utilized. Other outcomes allowed for the evaluation of novel end points, such as brain fog and participant-defined good days. The baseline population included 190 participants (female, 88.9%; 35–54 years of age, 53.7%). At month 6, 44.1% (95% confidence interval (CI): 35.3–53.4%) of participants reported “much/very much improved” on PGIC, and 75.7% (95% CI: 66.9–82.7%) reported any improvement. Mean good days increased by 6.3 per month at month 6 ( P  < 0.001). Among participants reporting brain fog at baseline (93.7%), 55.8% (95% CI: 46.2–64.9%) reported improvement at month 6. This research provides insights into capturing the broader migraine burden and the holistic impact of preventive treatment and highlights the potential for achieving ambitious goals. In this population for whom ≥1 prior CGRP-targeted preventive therapy had failed, switching to eptinezumab was associated with participant-reported, clinically meaningful improvements in PROs, including frequency, disability, disease status, and brain fog.

Citation format

STARLING, Amaal J., et al. Patient-reported outcomes from a real-world evidence study in individuals with migraine initiating eptinezumab after ≥1 prior calcitonin gene-related peptide (cgrp)-targeted preventive therapy. Cephalalgia Reports, 2026, 9.