Real-World INFUSE Data Show IV Eptinezumab Improves Outcomes After CGRP Failure

New data from the real-world INFUSE trial showed that switching to intravenous eptinezumab (Vyepti; Lundbeck) was associated with meaningful real-world improvements in patient-reported global status and headache burden in adults with migraine who had previously failed one or more prior calcitonin gene-related peptide (CGRP) preventive therapy.^1,2

Presented at the recently concluded 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference, the real-world, 12-month study included 190 participants, with 111 having efficacy data through at least 6 months. The cohort reflected substantial disease burden, with more than 80% diagnosed with chronic migraine and a mean of over 20 monthly headache days at baseline. Notably, more than half had failed three or more prior CGRP-directed options, underscoring the refractory nature of the population.

By Month 6, after 2 infusions, clinically meaningful improvements were observed across both patient-reported and frequency-based measures. A total of 44.1% of participants reported being “much improved” or “very much improved” on the Patient Global Impression-Change (PGIC), with signals of benefit evident as early as Day 7. Mean monthly headache days were reduced by 6.8 days at Month 6 (P <.001), and 44.1% achieved at least a 50% reduction.

“IV eptinezumab is the only infusion CGRP-targeted therapy for the prevention of migraine, and the fact that it is an infusion really sets it apart, because it reaches 100% bioavailability at the end of the infusion,” study author Amaal Starling, MD, FAHS, FAAN, told NeurologyLive^®.“It really takes away that patient-to-patient variability in absorption, because it is an infusion and it is achieving 100% bioavailability in every individual. It’s very consistent amongst patient to patient.”

Eptinezumab, a monoclonal antibody, was approved in 2020 as the first IV-formulated monoclonal for the preventive treatment of migraine in adults. It is administered via 30-minute IV infusion every 3 months, commonly at a 100 mg dose.

Beyond traditional frequency metrics, INFUSE also captured patient-defined “good days,” a functional measure increasingly emphasized in contemporary migraine research. Overall, participants reported a mean increase of 6.3 good days per month by Month 6 (P <.001), suggesting that clinical improvements translated into tangible gains in daily functioning.

READ MORE: Chronic Migraine Prevention in Diverse Populations: What the COMPEL Trial Reveals

Starling, an associate professor of neurology at Mayo Clinic College of Medicine, cited that the study signifies a shift to more patient-centered outcomes, adding “I love that I can take data and translate it directly to patients and talk about good days and talk about being much improved or very much improved, rather than talking about symptom burden and headache days.”

Coming into the study, most participants had been off CGRP-targeted treatments for at least 6 months (44.2%), while some were on them as recently as 1-3 months prior (23.2%). In terms of time from diagnosis, the cohort featured primarily those with at least 15 years of disease (55.3%), with fewer patients in that 6-15 year range (27.4%). Additional data from INFUSE showed that by month 3, 17.9% of treated participants had a 75% reduction in baseline MIDAS-derived monthly headache days (MHDs). Notably, this number improved to 26.1% by month 6.

Over the last few years, there has been a push to get CGRP-targeting therapies as first line-options for migraine prevention. In early 2024, the American Headache Society (AHS) published an updated position statement that supported these therapies as first-line treatments, using years of growing clinical data and experience as supporting evidence.³ While clinically the shift is already happening, there are still barriers like payer restrictions, cost considerations, and insurance, that have slowed the slowed this transitional phase.

Starling, a study author on that consensus statement, added that “In the past, we used to kind of try therapies, then we would try another set of therapies, and we were hoping that these therapies would become effective as we continued to elevate the robust effectiveness of the therapies. But I really want to try to turn that paradigm shift around and get people effective, robust therapy as early as possible.”

REFERENCES
1. Lundbeck presents new real-world data highlighting meaningful improvements in patients severely impacted by migraine initiating Vyepti® (eptinezumab), at HCOP Annual Conference. News release. January 30, 2026. Accessed March 2, 2026. https://www.lundbeck.com/us/newsroom/2026/lundbeck-presents-new-real-world-data-highlighting-meaningful-im
2. Starling A, Regnier SA, Soni-Brahmbhatt S, et al. Treatment With Eptinezumab After ≥1 Prior aCGRP Preventive Treatment Failed Resulted in Lower Migraine Burden and Improvements in Participant-Reported Outcomes: 6-Month Results for an Ongoing Prospective Study. Presented at: HCOP Annual Conference.
3. Charles AC, Digre KB, Goadsby PJ, et al. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024;64(4):333-341. doi:10.1111/head.14692