Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study.

IF 5
Corey C Ford, Jeffrey A Cohen, Andrew D Goodman, John W Lindsey, Robert P Lisak, Christopher Luzzio, Amy Pruitt, John Rose, Horea Rus, Jerry S Wolinsky, Shaul E Kadosh, Emily Bernstein-Hanlon, Yafit Stark, Jessica K Alexander
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引用次数: 1

Abstract

Background: Glatiramer acetate (GA) is US-approved for relapsing multiple sclerosis.

Objectives: To describe GA long-term clinical profile. To compare effectiveness of early start (ES) versus delayed start (DS; up to 3 years) with GA.

Methods: Phase 3 trial participants entered a randomized placebo-controlled period then an open-label extension (OLE) with GA.

Results: Overall, 208 out of 251 (82.9%) randomized participants entered the OLE; 24 out of 101 (23.8%, ES) and 28 out of 107 (26.2%, DS) participants completed the OLE. Median GA treatment was 9.8 (0.1-26.3) years. Annualized change in Expanded Disability Status Scale (EDSS) score was lower with ES versus DS (p = 0.0858: full study; p = 0.002; Year 5). Participants with improved/stable EDSS was consistently higher with ES versus DS: 40.3% versus 31.6% (p = 0.1590; full study); 70.8% versus 55.6% (p = 0.015; Year 5). ES prolonged time-to-6-month confirmed disease worsening (CDW) versus DS (9.8 vs 6.7 years), time-to-12-month CDW (18.9 vs 11.6 years), and significantly reduced time-to-second-6-month CDW (p = 0.0441). No new safety concerns arose.

Conclusion: GA long-term treatment maintained clinical benefit with a similar safety profile to phase 3 results; a key limitation was that only 25% of participants completed the OLE. Early initiation of GA had sustained benefits versus delayed treatment.

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醋酸格拉替默早期与延迟治疗:美国一项开放标签扩展研究中长达27年的连续随访分析
背景:醋酸格拉替默(GA)是美国批准用于复发性多发性硬化症的药物。目的:描述GA的长期临床特征。比较早开始(ES)和延迟开始(DS)的有效性;3年以上)。方法:3期试验参与者进入随机安慰剂对照期,然后是GA的开放标签扩展(OLE)。结果:总体而言,251名随机受试者中有208名(82.9%)进入OLE;101名参与者中有24名(23.8%,ES)和107名参与者中有28名(26.2%,DS)完成了OLE。GA治疗的中位数为9.8(0.1-26.3)年。扩展残疾状态量表(EDSS)评分的年化变化在ES组比DS组更低(p = 0.0858:完整研究;p = 0.002;改善/稳定EDSS的参与者与DS相比,ES始终更高:40.3%对31.6% (p = 0.1590;完整的研究);70.8%对55.6% (p = 0.015;与DS相比,ES延长了至6个月的确诊疾病恶化时间(CDW)(9.8年vs 6.7年),延长了至12个月的CDW时间(18.9年vs 11.6年),并显著缩短了至第二至6个月的CDW时间(p = 0.0441)。没有出现新的安全问题。结论:GA长期治疗保持临床获益,安全性与3期结果相似;一个关键的限制是只有25%的参与者完成了OLE。与延迟治疗相比,早期GA治疗有持续的益处。
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