Randomized study combining interferon and glatiramer acetate in multiple sclerosis.
Randomized study combining interferon and glatiramer acetate in multiple sclerosis.
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DOI：
10.1002/ana.23863
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发表时间：
2013-03
影响因子：
11.2
通讯作者：
Wolinsky, Jerry S.
中科院分区：
文献类型：
--
作者：
Lublin, Fred D.;Cofield, Stacey S.;Cutter, Gary R.;Conwit, Robin;Narayana, Ponnada A.;Nelson, Flavia;Salter, Amber R.;Gustafson, Tarah;Wolinsky, Jerry S.
一项双盲、随机、对照研究，旨在确定联合使用干扰素β-1a(干扰素)每周30微克肌注和醋酸格拉替拉默(GA)每日20毫克是否比单独使用任何一种药物治疗复发-缓解型多发性硬化症(RRMS)更有效。1008名参与者被随机抽样并跟踪，直到最后一名参与者完成3年。主要终点是利用对复发的严格定义降低年化复发率。次要结果包括确认残疾的时间、多发性硬化症功能复合体(MSFC)评分和MRI指标。在复发风险方面，联合应用干扰素和GA并不优于单一用药(GA)。联合治疗和GA在降低复发风险方面均明显优于干扰素。联合用药在减少确诊的EDSS进展或36个月后MSFC的变化方面并不比单独使用任何一种药物更好。联合用药在减少新的病变活动性和总病变体积积累方面优于单独使用任何一种制剂。在一项事后分析中，在MRI结果的推动下，联合治疗导致参与者达到无疾病活动状态(DAFS)的比例比任何一组患者都高。结合两种最常用的治疗多发性硬化症的处方疗法，在三年的时间里没有产生显著的临床益处。在一些MRI指标上看到了影响。在比较疗效的测试中，GA在降低病情恶化风险方面优于干扰素。CombiRx的扩展阶段将解决在MRI和DAFS结果中观察到的差异是否可以预测以后的临床差异。
A double-blind, randomized, controlled study to determine if combined use of interferon beta-1a (IFN) 30ug IM weekly and glatiramer acetate (GA) 20mg daily is more efficacious than either agent alone in relapsing-remitting multiple sclerosis (RRMS). 1008 participants were randomized and followed until the last participant enrolled completed 3 yrs. The primary endpoint was reduction in annualized relapse rate utilizing a strict definition of relapse. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics. Combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The Combination was not better than either agent alone in lessening confirmed EDSS progression or change in MSFC over 36 months. The combination was superior to either agent alone in reducing new lesion activity and accumulation of total lesion volumes. In a post hoc analysis, combination therapy resulted in a higher proportion of participants attaining disease activity free status (DAFS) compared to either single arm; driven by the MRI results. Combining the two most commonly prescribed therapies for MS did not produce a significant clinical benefit over three years. An effect was seen on some MRI metrics. In a test of comparative efficacy, GA was superior to IFN in reducing the risk of exacerbation. The extension phase for CombiRx will address if the observed differences in MRI and DAFS findings predict later clinical differences.
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影响因子：
11.2
作者：
McDonald, WI;Compston, A;Wolinsky, JS
通讯作者：
Wolinsky, JS
影响因子：
1.9
作者：
Graber, J. J.;McGraw, C. A.;Dhib-Jalbut, S.
通讯作者：
Dhib-Jalbut, S.
影响因子：
9.9
作者：
Rudick, RA;Fisher, E;Jacobs, L
通讯作者：
Jacobs, L
影响因子：
4.4
作者：
Khan, Omar;Bao, Fen;Zak, Imad
通讯作者：
Zak, Imad
影响因子：
9.9
作者：
Rao, AB;Richert, N;Frank, JA
通讯作者：
Frank, JA