Goadsby Peter J, Barbanti Piero, Lambru Giorgio, Ettrup Anders, Christoffersen Cecilie Laurberg, Josiassen Mette Krog, Phul Ravinder, Sperling Bjørn
NIHR SLaM Clinical Research Facility, and Headache Group Wolfson CARD, King's College London, London, UK.
Department of Neurology, University of California, Los Angeles, CA, USA.
Eur J Neurol. 2023 Apr;30(4):1089-1098. doi: 10.1111/ene.15670. Epub 2023 Jan 21.
In the phase 3b, randomized, double-blind, placebo-controlled DELIVER clinical trial, eptinezumab reduced migraine frequency and headache in adults with two to four prior preventive treatment failures. Here, the effect of eptinezumab on coinciding patient-reported outcomes is reported.
Adults were randomized to receive eptinezumab 100, 300 mg or placebo intravenously at weeks 12 and 24. The EQ-5D-5L, measuring overall patient health, and the six-item Headache Impact Test were completed every 4 weeks. The Patient Global Impression of Change was completed at weeks 4, 12 and 24. Patient-identified most bothersome symptom and the Migraine-Specific Quality of Life Questionnaire were administered at weeks 12 and 24.
Eptinezumab improved patient-reported outcomes more than placebo, starting at week 4 and at all subsequent time points. By week 12, patients' overall health (EQ-5D-5L visual analog scale score) improved with eptinezumab treatment (difference from placebo in change from baseline: 100 mg, 5.1, 95% confidence interval [CI] 2.2, 8.1, p < 0.001; 300 mg, 7.5, 95% CI 4.5, 10.4, p < 0.0001). At week 12, eptinezumab improved headache-related quality of life (difference from placebo in change from baseline in Headache Impact Test total score: 100 mg, -3.8, 95% CI -5.0, -2.5, p < 0.0001; 300 mg, -5.4, 95% CI -6.7, -4.2, p < 0.0001), including each Migraine-Specific Quality of Life Questionnaire domain (p ≤ 0.0001, all comparisons). Over twice as many patients receiving eptinezumab than placebo reported much or very much improvement on the Patient Global Impression of Change and patient-identified most bothersome symptom.
Patients with two to four prior preventive treatment failures receiving eptinezumab versus placebo reported greater improvements in well-being, quality of life and most bothersome symptoms compared to placebo.
ClinicalTrials.gov identifier: NCT04418765; EudraCT identifier: 2019-004497-25.
在3b期随机、双盲、安慰剂对照的DELIVER临床试验中，eptinezumab可降低既往有两至四次预防性治疗失败的成年患者的偏头痛发作频率和头痛程度。在此，报告eptinezumab对同时出现的患者报告结局的影响。
成年患者在第12周和第24周被随机分组，分别静脉注射100 mg、300 mg的eptinezumab或安慰剂。每4周完成一次用于评估患者总体健康状况的EQ-5D-5L量表以及六项头痛影响测试。在第4周、第12周和第24周完成患者总体印象变化评估。在第12周和第24周进行患者确定的最困扰症状评估以及偏头痛特异性生活质量问卷评估。
从第4周及之后的所有时间点来看，eptinezumab在改善患者报告结局方面均优于安慰剂。到第12周时，eptinezumab治疗使患者的总体健康状况（EQ-5D-5L视觉模拟量表评分）得到改善（与安慰剂相比，自基线的变化差异：100 mg组为5.1，95%置信区间[CI]为2.2, 8.1，p < 0.001；300 mg组为7.5，95% CI为4.5, 10.4，p < 0.0001）。在第12周时，eptinezumab改善了与头痛相关的生活质量（与安慰剂相比，头痛影响测试总分自基线的变化差异：100 mg组为 -3.8，95% CI为 -5.0, -2.5，p < 0.0001；300 mg组为 -5.4，95% CI为 -6.7, -4.2，p < 0.0001），包括偏头痛特异性生活质量问卷的各个领域（所有比较，p≤0.0001）。与安慰剂组相比，接受eptinezumab治疗的患者在患者总体印象变化评估和患者确定的最困扰症状方面报告有很大或非常大改善的人数是安慰剂组的两倍多。
与安慰剂相比，既往有两至四次预防性治疗失败的患者接受eptinezumab治疗后，在幸福感、生活质量和最困扰症状方面的改善程度更大。
ClinicalTrials.gov标识符：NCT04418765；EudraCT标识符：2019-004497-25。
