Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data
Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data
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DOI：
10.1111/j.1600-0404.2004.00351.x
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发表时间：
2005-01-01
影响因子：
3.5
通讯作者：
Wolinsky, JS
中科院分区：
文献类型：
--
作者：
Johnson, KP;Ford, CC;Wolinsky, JS
评估醋酸格拉替雷（GA）连续治疗复发缓解型多发性硬化（RRMS）的长期疗效。方法：这项开放标签的扩展研究是在一项为期约30个月的随机、安慰剂对照、双盲GA研究之后进行的。最初随机分配至GA组的患者继续使用GA（A组），随机分配至安慰剂组的患者转为GA（B组）。结果-在251名原始患者中，142名（56.6%）在8年后仍留在研究中。两组的年复发率下降至约0.2（约每5年复发1次）。然而，与B组相比，A组中扩展残疾状态量表评分稳定或改善的患者比例显著更高（分别为65.3%和50.4%; P = 0.0263），这可能归因于B组中GA治疗延迟约30个月。GA耐受性良好，未观察到药物相关的实验室变化。结论：这些数据支持早期开始GA治疗作为RRMS患者的有效和耐受性良好的长期治疗。
Objective-To assess the long-term effectiveness of continuous glatiramer acetate (GA) therapy in relapsing-remitting multiple sclerosis (RRMS). Methods-This open-label extension followed a randomized, placebo-controlled, double-blind study of GA of approximately 30 months duration. Patients originally randomized to GA continued on it (group A) and those randomized to placebo switched to GA (group B). Results-Of 251 original patients, 142 (56.6%) remained in the study after 8 years. Annual relapse rate for both groups declined to approximately 0.2 (approximately one relapse every 5 years). However, a significantly larger proportion of patients in group A had stable or improved Expanded Disability Status Scale scores compared with group B (65.3% vs 50.4%, respectively; P = 0.0263), possibly attributable to the delay of GA treatment for approximately 30 months in group B. GA was well tolerated and no drug-related laboratory changes were observed. Conclusions-These data support early initiation of GA therapy as an efficacious and well-tolerated long-term treatment for RRMS patients.