Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial
Abstract
BACKGROUND: In the phase 3 SUNRISE trial conducted in a predominantly Asian population with chronic migraine (CM), eptinezumab (100 or 300 mg) met the primary and all key secondary endpoints and was well-tolerated. The open-label SUNSET extension trial was conducted in Japanese participants from SUNRISE and evaluated long-term safety, tolerability, and effectiveness of eptinezumab. METHODS: After completing the 12-week double-blind period of SUNRISE, the first 160 Japanese participants enrolled in SUNSET and 159 received eptinezumab every 12 weeks for 60 weeks. At the SUNSET baseline visit (also SUNRISE Week 12), all participants received an infusion of eptinezumab 100 mg. For those with a < 50% reduction in monthly migraine days (MMDs) during SUNSET Weeks 1–12 relative to baseline values obtained in SUNRISE, the dose of eptinezumab was increased to 300 mg at SUNSET Week 12. The primary outcome was safety and tolerability (based on treatment-emergent adverse events); secondary outcomes were maintenance of migraine-preventive effect and impact on health-related quality of life (e.g, Patient Global Impression of Change [PGIC], patient-identified most bothersome symptom [PI-MBS], and Migraine-specific Work Productivity and Activity Impairment [WPAI:M]). Baseline values reported are from the SUNRISE trial. RESULTS: Among 159 treated participants, 141 (88.7%) completed SUNSET. Evaluable participants were mostly female (87.4%), with a mean age of 41.9 years and a mean of 17.1…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 160 participants or records.
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