Efficacy and safety of eptinezumab in a predominantly Asian population with chronic migraine: Results of the randomized, double-blind, placebo-controlled SUNRISE trial

Aim We aimed to evaluate the efficacy and safety of eptinezumab for the preventive treatment of chronic migraine in a predominantly Asian population. Methods The multi-regional, randomized, double-blind, placebo-controlled, phase 3 SUNRISE trial randomly assigned adults with chronic migraine to receive eptinezumab 100 mg, 300 mg, or placebo. The primary endpoint was change from baseline in monthly migraine days (MMDs) during Weeks 1–12. Key secondary efficacy endpoints were 50% reduction in MMDs (Weeks 1–12) and 75% reduction in MMDs (Weeks 1–4, Weeks 1–12), and the percentage of participants experiencing migraine on Day 1. Results Overall, 978 participants received treatment, including 621 (63.5%) from Asia. Both eptinezumab doses met the primary and all key secondary efficacy endpoints. The mean change from baseline in MMDs (Weeks 1–12) was −7.2 for eptinezumab 100 mg, −7.5 for eptinezumab 300 mg, and −4.8 for placebo. Between-group differences were −2.4 for eptinezumab 100 mg versus placebo ( p < 0.0001) and −2.7 for eptinezumab 300 mg versus placebo ( p < 0.0001). Both eptinezumab doses also demonstrated an odds ratio of >2 versus placebo for all migraine responder rates ( p < 0.0001), and a lower percentage of participants experiencing migraine on Day 1 versus placebo ( p ≤ 0.01). Safety outcomes were similar across treatment groups. Conclusions Eptinezumab demonstrated statistically significant greater reductions in MMDs compared with placebo, beginning on Day 1 and sustained through Week 12, with a well-tolerated safety profile consistent with prior clinical trials. Trial registration ClinicalTrials.gov (Identifier: NCT04921384); EudraCT (Identifier: 2020-001657-42).