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Background <p>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.</p> Methods <p>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 &lt; 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.</p> Results <p>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 baseline MMDs. No new safety signals were identified, and few participants had a serious adverse event (3.1%), event leading to withdrawal (4.4%), or infusion interruption/termination (5.0%). MMD reductions from the lead-in placebo-controlled trial were maintained during SUNSET, and just over 35% of participants had ≥50% reduction in MMDs from Week 24 onwards. PGIC scores showed that ~50% of participants were very much or much improved from Week 24 onwards. From the lead-in placebo-controlled trial, PI-MBS scores and WPAI:M domain scores for presenteeism, work productivity loss, and activity impairment showed sustained improvement over 60 weeks.</p> Conclusions <p>Long-term (60 weeks) treatment with eptinezumab was found to maintain reductions in migraine frequency and severity from the placebo-controlled lead-in trial, with no new safety concerns. These results confirm the effectiveness of eptinezumab in Japanese participants with CM to reduce the burden of migraine and improve the ability to undertake daily life activities.</p> Trial Registration <p>ClinicalTrials.gov (Identifier: NCT05064371; date of registration: September 22, 2021)</p>

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Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial

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  • 发表日期：

    2025年11月22日

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  • Takao Takeshima,
  • Daisuke Danno,
  • Noboru Imai,
  • Keisuke Suzuki,
  • Anders Ettrup,
  • Sidsel Jensen,
  • Mette Krog Josiassen,
  • Aurélia Mittoux,
  • Yasuhiko Matsumori

摘要

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 baseline MMDs. No new safety signals were identified, and few participants had a serious adverse event (3.1%), event leading to withdrawal (4.4%), or infusion interruption/termination (5.0%). MMD reductions from the lead-in placebo-controlled trial were maintained during SUNSET, and just over 35% of participants had ≥50% reduction in MMDs from Week 24 onwards. PGIC scores showed that ~50% of participants were very much or much improved from Week 24 onwards. From the lead-in placebo-controlled trial, PI-MBS scores and WPAI:M domain scores for presenteeism, work productivity loss, and activity impairment showed sustained improvement over 60 weeks.

Conclusions

Long-term (60 weeks) treatment with eptinezumab was found to maintain reductions in migraine frequency and severity from the placebo-controlled lead-in trial, with no new safety concerns. These results confirm the effectiveness of eptinezumab in Japanese participants with CM to reduce the burden of migraine and improve the ability to undertake daily life activities.

Trial Registration

ClinicalTrials.gov (Identifier: NCT05064371; date of registration: September 22, 2021)