Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis
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DOI：
10.1002/ana.23938
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发表时间：
2013-06-01
影响因子：
11.2
通讯作者：
Zivadinov, Robert
中科院分区：
文献类型：
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作者：
Khan, Omar;Rieckmann, Peter;Zivadinov, Robert
目的评价醋酸格拉替默（GA） 40mg治疗复发-缓解型多发性硬化症（RRMS）患者的疗效和安全性，与安慰剂相比，每周3次（tiw）。方法本研究在17个国家的142个地点进行随机、双盲研究。RRMS患者在筛查前12个月内至少有1次复发，或在筛查前24个月内至少有2次复发，且扩展残疾状态量表评分为5.5分，随机分为2:1，接受皮下（sc） GA 40mg tiw （1ml）或安慰剂治疗12个月。结果在1524例筛选的患者中，1404例随机接受GA 40mg sctiw （n = 943）或安慰剂（n = 461）。安慰剂组和GA组分别有93%和91%的患者完成了为期12个月的研究。与安慰剂相比，GA 40mg tiw与确诊复发风险降低34.0%相关（平均年复发率= 0.331 vs 0.505; p < 0.0001）。在第6个月和第12个月，接受GA 40mg tiw治疗的患者在钆增强T1（44.8%）和新发或新扩大T2病变（34.7%）的累积数量上显著减少（p < 0.0001）。GA每次40mg是安全且耐受性良好的。GA组最常见的不良事件是注射部位反应（GA组为35.5%，安慰剂组为5.0%）。解释：40mg sctiw是一种安全有效的RRMS治疗方案，提供了每周较少sctiw注射的便利。
ObjectiveTo assess the efficacy and safety of glatiramer acetate (GA) 40mg administered 3x weekly (tiw) compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).MethodsThis randomized, double-blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least 1 documented relapse in the 12 months before screening, or at least 2 documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg tiw (1ml) or placebo for 12 months.ResultsOf 1,524 patients screened, 1,404 were randomized to receive GA 40mg sc tiw (n = 943) or placebo (n = 461). Ninety-three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12-month study. GA 40mg tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium-enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo).InterpretationGA 40mg sc tiw is a safe and effective regimen for the treatment of RRMS, providing the convenience of fewer sc injections per week.