Switch to Natalizumab versus Fingolimod in Active Relapsing-Remitting Multiple Sclerosis
Switch to Natalizumab versus Fingolimod in Active Relapsing-Remitting Multiple Sclerosis
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DOI：
10.1002/ana.24339
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发表时间：
2015-03-01
影响因子：
11.2
通讯作者：
Butzkueven, Helmut
中科院分区：
文献类型：
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作者：
Kalincik, Tomas;Horakova, Dana;Butzkueven, Helmut
在患有多发性硬化症活动的患者中，尽管使用干扰素或醋酸格拉替雷治疗，临床医生通常将治疗转换为那他珠单抗或芬戈莫德。然而，没有研究直接比较切换到这些agentsMethodsUsing MSBase，一个大型的国际，观察，前瞻性获得队列研究的结果，我们确定了复发缓解型多发性硬化症患者在6个月内经历复发或残疾进展之前立即切换到那他珠单抗或芬戈莫德。采用基于倾向评分匹配的准随机化选择具有可比基线特征的亚群。复发和残疾的结果进行了比较配对，配对删失analysis.ResultsOf纳入792例患者，578例患者匹配（那他珠单抗，n=407;芬戈莫德，n=171）。平均研究期间随访时间为12个月。那他珠单抗组的年复发率从1.5降至0.2，芬戈莫德组从1.3降至0.4，复发风险的相对转换后差异为50%（p=0.002）。与芬戈莫德相比，转换为那他珠单抗后观察到的持续残疾消退率高2.8倍（p
ObjectiveIn patients suffering multiple sclerosis activity despite treatment with interferon or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents.MethodsUsing MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses.ResultsOf the 792 included patients, 578 patients were matched (natalizumab, n=407; fingolimod, n=171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p=0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p