Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
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DOI：
10.1177/1352458512469695
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发表时间：
2013-07-01
影响因子：
5.8
通讯作者：
Filippi, Massimo
中科院分区：
文献类型：
--
作者：
Comi, Giancarlo;Martinelli, Vittorio;Filippi, Massimo
背景：精确研究的安慰剂对照阶段显示，在临床隔离综合征和脑病变患者中，临床明确的多发性硬化症(CDMS)的发病延迟了临床隔离综合征和脑部病变的磁共振成像。目的：比较临床隔离综合征早期和延迟治疗的效果。方法：临床隔离综合征提示MS单灶性表现和2个T2加权的脑部病变的患者随机分为两组，分别接受20 mg/d(早期治疗，n=198)或安慰剂(延迟治疗，n=211)治疗36个月或直到转为CDMS，结果：早期治疗使CDMS转换风险降低41%(危险比0.59，95%可信区间0.44-0.80；P=0.0005)与延迟治疗相比，这与转换为CDMS的延迟972天(185%)、较少的脑萎缩(-28%，P=0.0209)、较少的新T2病变/年(-42%)相关。
Background: The placebo-controlled phase of the PreCISe study showed that glatiramer acetate delayed onset of clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome and brain lesions on MRI.Objective: To compare the effects of early versus delayed glatiramer acetate treatment in the open-label phase of PreCISe.Methods: Patients with a clinically isolated syndrome suggestive of MS with unifocal manifestation and 2 T2-weighted brain lesions were randomized to receive glatiramer acetate 20 mg/d (early-treatment, n=198) or placebo (delayed-treatment, n=211) for 36 months or until conversion to CDMS, followed by open-label glatiramer acetate treatment for two years.Results: Early glatiramer acetate treatment reduced CDMS conversion risk by 41% (hazard ratio 0.59, 95% confidence interval 0.44-0.80; p=0.0005) versus delayed-treatment, and was associated with a 972-day delay (185%) in conversion to CDMS, less brain atrophy (-28%, p=0.0209), fewer new T2 lesions/year (-42%,