加卡尼单抗治疗对日本发作性偏头痛患者偏头痛特异性生活质量问卷（MSQ）2.1版评分的改善：日本2期研究
Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study.
作者信息
Shibata Mamoru, Nakamura Tomomi, Ozeki Akichika, Ueda Kaname, Nichols Russell M
机构信息
Department of Neurology, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan.
Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
出版信息
J Pain Res. 2020 Dec 31;13:3531-3538. doi: 10.2147/JPR.S287781. eCollection 2020.
PURPOSE
Evaluate changes from baseline in health-related quality of life (QoL) in Japanese patients with episodic migraine receiving preventive treatment with galcanezumab (GMB).
PATIENTS AND METHODS
Preventive treatments for migraine have been shown to improve QoL, but few clinical trials have examined QoL outcomes in Japanese patients. This phase 2, randomized, double-blind, placebo-controlled study was conducted at 40 centers in Japan. Patients aged 18-65 years with episodic migraine (4-14 monthly migraine headache days) received GMB 120 mg (n=115), 240 mg (n=114), or placebo (PBO, n=230) as monthly subcutaneous injections for 6 months. QoL was measured monthly using the Migraine-Specific Quality-of-Life Questionnaire (MSQ) version 2.1. Prespecified analyses were differences between GMB and PBO for change from baseline in all 3 domains of the MSQ and MSQ-Total, for each month and the average over Months 4-6.
RESULTS
Treatment with GMB significantly increased MSQ scores from baseline vs PBO. Average change ± SE from baseline across Months 4-6 was 10.12±0.72 (PBO), 17.13±1.03 (GMB 120 mg; <0.001), and 15.91±1.03 (GMB 240 mg; <0.001) for MSQ Role Function-Restrictive; 4.80±0.65 (PBO), 9.64±0.93 (GMB 120 mg; <0.001), and 8.35±0.93 (GMB 240 mg; <0.05) for MSQ Role Function-Preventive (MSQ-RFP); 3.46±0.77 (PBO), 10.04±1.10 (GMB 120 mg; <0.001), and 7.73±1.10 (GMB 240 mg; <0.05) for MSQ Emotional Function, and 7.14±0.67 (PBO), 13.46±0.95 (GMB 120 mg; <0.001), and 11.98±0.95 (GMB 240 mg; <0.001) for MSQ-Total. Significantly greater improvement in scores in all MSQ domains and MSQ-Total was observed for both GMB doses vs PBO at Month 1 and was maintained for Months 1-6 (excluding Month 5 for MSQ-RFP).
CONCLUSION
Preventive treatment with GMB 120 mg/240 mg improves MSQ scores in Japanese patients with episodic migraine. Improvements were seen within the first month and maintained for 6 months and are similar to those seen in global studies enrolling primarily Caucasian patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02959177 (registered November 7, 2016).
目的
评估接受加卡尼单抗（GMB）预防性治疗的日本发作性偏头痛患者健康相关生活质量（QoL）相对于基线的变化。
患者与方法
偏头痛预防性治疗已被证明可改善生活质量，但很少有临床试验研究日本患者的生活质量结果。这项2期、随机、双盲、安慰剂对照研究在日本的40个中心进行。年龄在18 - 65岁、患有发作性偏头痛（每月偏头痛头痛天数为4 - 14天）的患者每月皮下注射GMB 120 mg（n = 115）、240 mg（n = 114）或安慰剂（PBO，n = 230），持续6个月。每月使用偏头痛特异性生活质量问卷（MSQ）2.1版测量生活质量。预先设定的分析是GMB与PBO在MSQ所有3个领域和MSQ总分相对于基线变化的差异，针对每个月以及第4 - 6个月的平均值。
结果
与PBO相比，GMB治疗使MSQ评分相对于基线显著增加。第4 - 6个月相对于基线的平均变化±标准误，MSQ角色功能 - 限制性方面，PBO为10.12±0.72，GMB 120 mg为17.13±1.03（P < 0.001），GMB 240 mg为15.91±1.03（P < 0.001）；MSQ角色功能 - 预防性（MSQ - RFP）方面，PBO为4.80±0.65，GMB 120 mg为9.64±0.93（P < 0.001），GMB 240 mg为8.35±0.93（P < 0.05）；MSQ情绪功能方面，PBO为3.46±0.77，GMB 120 mg为10.04±1.10（P < 0.001），GMB 240 mg为7.73±1.10（P < 0.05）；MSQ总分方面，PBO为7.14±0.67，GMB 120 mg为13.46±0.95（P < 0.001），GMB 240 mg为11.98±0.95（P < 0.001）。在第1个月，两种GMB剂量组在所有MSQ领域和MSQ总分的评分改善均显著大于PBO组，且在第1 - 6个月保持（MSQ - RFP的第5个月除外）。
结论
120 mg/240 mg的GMB预防性治疗可改善日本发作性偏头痛患者的MSQ评分。在第一个月内即可见到改善，并持续6个月，且与主要纳入白种人的全球研究中所见结果相似。
临床试验注册
ClinicalTrials.gov，NCT02959177（2016年11月7日注册）
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