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Background <p>Migraine imposes a substantial global burden, with unmet patient-centered therapeutic needs. Rimegepant, a CGRP receptor antagonist, has trial-proven efficacy, but real-world evidence for its dual acute and preventive use in Chinese migraine populations is limited. This study evaluated its effectiveness in Chinese patients using patient-reported outcomes.</p> Methods <p>A multicenter, single-arm, prospective, non-interventional observational study was conducted across five hospitals in the Guangdong-Hong Kong-Macao Greater Bay Area, China. A total of 120 adult migraine patients who were prescribed rimegepant for either acute (AT) or preventive treatment (PT) were enrolled. Patient-reported outcomes were assessed at baseline and after 4 weeks using Headache Impact Test (HIT-6), Treatment Satisfaction Questionnaire for Medication (TSQM), the European Five-Dimension Five-Level Health Scale (EQ-5D-5L) and the Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH). We employed the Wilcoxon signed-rank test for within-group comparisons of pre- and post-treatment scale scores, with statistically significant defined as a two-tailed p-value &lt; 0.05.</p> Results <p>A total of 120 migraine patients meeting all inclusion criteria were enrolled but 12 potential participants (10.0%) did not initiate rimegepant therapy. The study was completed by 108 patients (median age 37.0 (31.5,46.0) years; 83% female), including 89 in the AT group and 19 in the PT group. After 4 weeks, both groups showed significant improvements. In the AT group, the HIT-6 score decreased by 4.8 (95% CI: -6.1, -3.0), while TSQM scores increased in Effectiveness (20.6; 95% CI: 14.3, 26.8), Side Effects (12.6; 95% CI: 6.8, 18.5), and Global Satisfaction (16.2, 95% CI: -10.8, 21.5); for all comparisons to baseline, <i>P</i> &lt; 0.0001. The PT group also showed an improvement in the HIT-6 (-5.8 [95% CI: -9.5, -2.2]) and improvements in TSQM (11.4 [95% CI: -0.8, 23.6] for Effectiveness, 13.2 [95% CI: -0.1, 26.4] for Side Effects,12.0 [95% CI: 0.2, 23.8] for Global Satisfaction). Both the AT and PT groups reported improvement in EQ-5D-5L VAS scores (3.6 [95% CI: 1.0, 6.2] and 7.6 [95% CI: 1.8, 13.5]) and improvement in WPAI-GH measures, including presenteeism (-10.6 and − 26.4) and overall work impairment (-11.3 and − 22.4); for all comparisons to baseline, <i>P</i> &lt; 0.05). A clinically relevant improvement (≥ 6-point reduction in HIT-6 scores) was achieved by 52.6% of PT group and 34.1% of AT group. The PT group was relatively small, and due to the limited duration of follow-up, it may have demonstrated preliminary preventive effects.</p> Conclusions <p>Rimegepant demonstrated improvements across multiple patient-centered outcomes, including headache-related impacts (HIT-6), treatment satisfaction (TSQM), quality of life (EQ-5D-5L), functional capacity and work productivity (WPAI). Therapeutic benefits were observed in both AT and PT, with the PT group showing preliminary evidence of preventive effects, further supporting rimegepant’s dual indications in migraine management.</p> Trial registration <p>The study is registered on ClinicalTrials.gov (NCT06221267).</p>

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Patient-reported outcomes of rimegepant for acute and preventive treatment of migraine in China: a prospective, multicenter, real-world study

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  • 发表日期：

    2025年11月7日

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  • Jinyuan Wang,
  • Jingru Jiang,
  • Sudan Peng,
  • Jie Jiang,
  • Zhonglin Liu,
  • Jifu Cai,
  • Jin Li,
  • Yi Li,
  • Ying Chen,
  • Honghong Li,
  • Xiaoming Rong,
  • Lei He,
  • Li Ren,
  • Yan Ji,
  • Sha Li,
  • Yingying Zhu,
  • Songhua Xiao,
  • Yamei Tang,
  • Yongteng Xu

摘要

Background

Migraine imposes a substantial global burden, with unmet patient-centered therapeutic needs. Rimegepant, a CGRP receptor antagonist, has trial-proven efficacy, but real-world evidence for its dual acute and preventive use in Chinese migraine populations is limited. This study evaluated its effectiveness in Chinese patients using patient-reported outcomes.

Methods

A multicenter, single-arm, prospective, non-interventional observational study was conducted across five hospitals in the Guangdong-Hong Kong-Macao Greater Bay Area, China. A total of 120 adult migraine patients who were prescribed rimegepant for either acute (AT) or preventive treatment (PT) were enrolled. Patient-reported outcomes were assessed at baseline and after 4 weeks using Headache Impact Test (HIT-6), Treatment Satisfaction Questionnaire for Medication (TSQM), the European Five-Dimension Five-Level Health Scale (EQ-5D-5L) and the Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH). We employed the Wilcoxon signed-rank test for within-group comparisons of pre- and post-treatment scale scores, with statistically significant defined as a two-tailed p-value < 0.05.

Results

A total of 120 migraine patients meeting all inclusion criteria were enrolled but 12 potential participants (10.0%) did not initiate rimegepant therapy. The study was completed by 108 patients (median age 37.0 (31.5,46.0) years; 83% female), including 89 in the AT group and 19 in the PT group. After 4 weeks, both groups showed significant improvements. In the AT group, the HIT-6 score decreased by 4.8 (95% CI: -6.1, -3.0), while TSQM scores increased in Effectiveness (20.6; 95% CI: 14.3, 26.8), Side Effects (12.6; 95% CI: 6.8, 18.5), and Global Satisfaction (16.2, 95% CI: -10.8, 21.5); for all comparisons to baseline, P < 0.0001. The PT group also showed an improvement in the HIT-6 (-5.8 [95% CI: -9.5, -2.2]) and improvements in TSQM (11.4 [95% CI: -0.8, 23.6] for Effectiveness, 13.2 [95% CI: -0.1, 26.4] for Side Effects,12.0 [95% CI: 0.2, 23.8] for Global Satisfaction). Both the AT and PT groups reported improvement in EQ-5D-5L VAS scores (3.6 [95% CI: 1.0, 6.2] and 7.6 [95% CI: 1.8, 13.5]) and improvement in WPAI-GH measures, including presenteeism (-10.6 and − 26.4) and overall work impairment (-11.3 and − 22.4); for all comparisons to baseline, P < 0.05). A clinically relevant improvement (≥ 6-point reduction in HIT-6 scores) was achieved by 52.6% of PT group and 34.1% of AT group. The PT group was relatively small, and due to the limited duration of follow-up, it may have demonstrated preliminary preventive effects.

Conclusions

Rimegepant demonstrated improvements across multiple patient-centered outcomes, including headache-related impacts (HIT-6), treatment satisfaction (TSQM), quality of life (EQ-5D-5L), functional capacity and work productivity (WPAI). Therapeutic benefits were observed in both AT and PT, with the PT group showing preliminary evidence of preventive effects, further supporting rimegepant’s dual indications in migraine management.

Trial registration

The study is registered on ClinicalTrials.gov (NCT06221267).