SUNRISE Trial Confirms Effectiveness of Eptinezumab in Asian Population With Chronic Migraine

Johan Luthman

Findings from the SUNRISE trial (NCT04921384), a pivotal study of Asian patients with chronic migraine (CM), revealed that treatment with eptinezumab (Vyepti; Lundbeck) at doses of 100 mg and 300 mg remained effective, reflected by significant reductions in monthly migraine days (MMDs) over a 12-week period.^1,2

Presented at the 11^th Congress of the European Academy of Neurology, the double-blind, pivotal trial met all its key primary and secondary end points, with eptinezumab outperforming placebo on a number of different metrics. Between weeks 1-12 , investigators recorded mean changes of –7.2 (100 mg), –7.5 (300 mg), and –4.8 (placebo) in MMDs, which were statistically significant for both eptinezumab doses (P <.0001).

"Various treatments are recommended for patients with migraine in Asia, however utilization and adherence to migraine-specific treatment is relatively low. Access to effective treatments remains a significant unmet medical need for migraine prevention in Asia," Johan Luthman, executive vice president and head of R&D at Lundbeck, said in a statement.¹ "The data from SUNRISE is consistent with previous results across diverse populations and will be pivotal for our efforts to expand access to eptinezumab for patients in Asia suffering with severe migraine."

Of the 983 patients randomized, 939 (95.5%) completed the placebo-controlled period, with few serious treatment-emergent adverse events (TEAEs; <2%) or TEAEs leading to withdrawal (<2%). Overall, treatment with eptinezumab led to a 2-fold higher odds versus placebo in patients achieving at least 50% reduction in MMDs over weeks 1-12 (100 mg; OR, 2.2; P <.0001; 300 mg: OR, 2.7; P <.0001) and higher odds of achieving at least 75% reduction in MMDs vs placebo over weeks 1-4 (100 mg: OR, 3.9; P <.0001; 300 mg: OR, 4.4; P <.0001) and weeks 1-12 (100 mg: OR, 2.9; P <.0001; 300 mg: OR, 3.0; P <.0001).

In the trial, the proportion of patients experiencing migraine on day 1 was lower in the eptinezumab group vs placebo (100 mg: 41.0%; 300 mg: 38.8%; placebo: 50.9%; P = .01 and P =.002, respectively). Eptinezumab-treated patients, who entered the trial with at least 15 monthly headache days and at least 8 MMDs, also had greater improvements in Patient Global Impression of Change (PGIC) score at week 12 and change in patient-identified most bothersome symptom (PI-MBS).

Patricia Pozo-Rosich, MD, PhD

"The SUNRISE trial marks a significant step forward in the mission to make migraine-specific preventive treatments more globally accessible, ensuring that patients with severe migraine receive the care they need," principal investigator Patricia Pozo-Rosich, MD, PhD, head of section of the Neurology Department, and director of Headache and Craniofacial Pain Clinical Unit and the Migraine Adaptive Brain Center at the Vall d’Hebron University Hospital, said in a statement.¹

In terms of safety, the rate of TEAEs across cohorts was similar, with 37.6%, 32.2%, and 33.5% of patients in the 300 mg, 100 mg, and placebo groups, respectively, experiencing at least 1 safety event. Overall, the most common TEAE was COVID-19 (100 mg: 5.5%; 300 mg: 4.6%; placebo: 4.3%) followed by nasopharyngitis (100 mg: 3.4%; 300 mg: 3.4%; placebo: 4.9%).

Eptinezumab, an anti-calcitonin gene-related peptide (CGRP) drug, was approved for prevention of migraine in adults in 2020. In addition to the SUNRISE trial, researchers also presented data from the RESOLUTION trial (NCT05452239), a study testing eptinezumab in patients with CM and medication-overuse headache (MOH), at the 2025 EAN Congress.³

RESOLUTION was a large-scale study of 608 patients with CM and MOH who were randomly assigned to eptinezumab 100 mg or placebo, with change in MMDs over a 4-week period as the primary end point. Results showed that patients on the approved medication had a change of –6.9 MMDs whereas those on placebo had changes of –3.7, which were statistically significant (P <.0001). During treatment, 37.8% of patients on eptinezumab vs 18.1% on placebo no longer met criteria for chronic migraine or MOH by weeks 1–4 (P < .0001), a difference that persisted through weeks 1–12 (27.2% vs 12.7%; P < .0001).

REFERENCES
1. New data from phase III trial confirms efficacy of Vyepti® (eptinezumab) in Asian population with chronic migraine. News release. Lundbeck. June 21, 2025. Accessed July 8, 2025. https://www.prnewswire.com/news-releases/new-data-from-phase-iii-trial-confirms-efficacy-of-vyepti-eptinezumab-in-asian-population-with-chronic-migraine-302487648.html
2. Yu S, Matsumori Y, Gryglas-Dworak A, et al. Efficacy and safety of eptinezumab in chronic migraine: a randomized placebo-controlled trial in a predominantly Asian population. Presented at: 2025 AHS Annual Meeting; June 27-30; Minneapolis, MN. Abstract P-308.
3. Jensen R, Lundqvist C, Schytz HW, et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: results from the randomized, placebo-controlled RESOLUTION trial. Presented at: 2025 AHS Annual Meeting; June 19-22. Minneapolis, MN. P-297