Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital, London, UK.
Headache. 2022 Jun;62(6):690-699. doi: 10.1111/head.14295. Epub 2022 Apr 25.
To assess the utility of the novel patient-identified (PI) most bothersome symptom (MBS) measure from PROMISE-2, a phase 3 trial of eptinezumab for the preventive treatment of chronic migraine.
Relief of bothersome migraine symptoms can influence satisfaction with treatment and therapeutic persistence. Understanding the impact of preventive treatment on a PI-MBS could improve clinical decision-making.
In PROMISE-2, patients with chronic migraine received eptinezumab 100, 300 mg, or placebo administered intravenously every 12 weeks for up to 2 doses (n = 1072). PI-MBS was an exploratory outcome requiring each patient to self-report their MBS in response to an open-ended question. At baseline and week 12, patients rated overall improvement in PI-MBS. The relationships among PI-MBS at week 12 and change in monthly migraine days (MMDs) from baseline to month 3 (weeks 9-12), Patient Global Impression of Change at week 12, and changes from baseline to week 12 in the 6-item Headache Impact Test total, EuroQol 5-dimensions 5-levels visual analog scale, and 36-item Short-Form Health Survey component scores were assessed.
Treatment groups had similar baseline characteristics and reported a total of 23 unique PI-MBS, most commonly light sensitivity (200/1072, 18.7%), nausea/vomiting (162/1072, 15.1%), and pain with activity (147/1072, 13.7%). Improvements in PI-MBS at week 12 correlated with changes in MMDs (ρ = -0.49; p < 0.0001) and other patient-reported outcomes. Controlling for changes in MMDs, PI-MBS improvement predicted other patient-reported outcomes in expected directions. The magnitude of the standardized mean differences between placebo and active treatment for PI-MBS were 0.31 (p < 0.0001 vs. placebo) and 0.54 (p < 0.0001 vs. placebo) for eptinezumab 100 and 300 mg, respectively.
Improvement in PI-MBS at week 12 was associated with improvement in other patient-reported outcome measures, and PI-MBS may be an important patient-centered measure of treatment benefits in patients with chronic migraine.
评估 PROMISE-2 中新型患者识别（PI）最困扰症状（MBS）测量的效用，这是一项针对依替扎尼布预防治疗慢性偏头痛的 3 期试验。
缓解困扰性偏头痛症状可能会影响对治疗的满意度和治疗持久性。了解预防性治疗对 PI-MBS 的影响可以改善临床决策。
在 PROMISE-2 中，慢性偏头痛患者接受依替扎尼布 100、300mg 或安慰剂静脉注射，每 12 周一次，最多 2 剂（n=1072）。PI-MBS 是一个探索性结局，需要每位患者对开放式问题自行报告其 MBS。在基线和第 12 周，患者评估 PI-MBS 的整体改善情况。第 12 周 PI-MBS 与从基线到第 3 个月（第 9-12 周）每月偏头痛天数（MMD）的变化、第 12 周患者整体变化印象和从基线到第 12 周 6 项头痛影响测试总分、欧洲五维健康量表 5 级视觉模拟量表和 36 项简明健康调查成分评分的变化之间的关系进行了评估。
治疗组具有相似的基线特征，共报告了 23 种独特的 PI-MBS，最常见的是光敏感（200/1072，18.7%）、恶心/呕吐（162/1072，15.1%）和活动时疼痛（147/1072，13.7%）。第 12 周 PI-MBS 的改善与 MMD 的变化（ρ=-0.49；p<0.0001）和其他患者报告的结局相关。在控制 MMD 变化的情况下，PI-MBS 的改善按预期方向预测了其他患者报告的结局。PI-MBS 改善的标准化均数差值与安慰剂相比，依替扎尼布 100mg 和 300mg 分别为 0.31（p<0.0001）和 0.54（p<0.0001）。
第 12 周 PI-MBS 的改善与其他患者报告结局测量指标的改善相关，PI-MBS 可能是慢性偏头痛患者治疗获益的重要以患者为中心的测量指标。
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