Comparative analysis of natalizumab versus fingolimod as second-line treatment in relapsing-remitting multiple sclerosis
Comparative analysis of natalizumab versus fingolimod as second-line treatment in relapsing-remitting multiple sclerosis
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DOI：
10.1177/1352458518768433
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发表时间：
2018-05-01
影响因子：
5.8
通讯作者：
Yaldizli, Ozgur
中科院分区：
文献类型：
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作者：
Lorscheider, Johannes;Benkert, Pascal;Yaldizli, Ozgur
背景资料：没有随机对照试验比较芬戈莫德或那他珠单抗作为复发缓解型多发性硬化症（RRMS）患者二线治疗的疗效。目的：比较芬戈莫德与那他珠单抗在临床活动性RRMS患者中递增后的临床结局。利用瑞士联邦卫生机构共同任务登记册，我们确定了在从干扰素β或醋酸格拉替雷转换为芬戈莫德或那他珠单抗前一年内复发1次的RRMS患者。倾向评分匹配用于选择具有可比基线特征的患者。复发和扩展残疾状态量表（EDSS）的结果进行了比较，配对，配对删失analysis.Results：纳入的547例患者中，358例匹配（芬戈莫德，n=179;那他珠单抗，n=179）。中位随访时间为1.8年（四分位数间距为0.9-2.9）。与芬戈莫德相比，换用那他珠单抗的患者复发风险较低（发生率比0.5，95%置信区间（CI）0.3-0.8，p=0.001），更有可能出现EDSS改善（风险比（HR）1.8，95% CI 1.1-2.7，p=0.01）。我们没有发现EDSS进展的患者比例存在差异（HR 0.9，95%CI 0.5-1.5，p=0.62）。结论：与芬戈莫德相比，那他珠单抗在降低复发率和改善残疾方面似乎更有效。
Background: No randomized controlled trials have compared the efficacy of fingolimod or natalizumab as second-line treatment in patients with relapsing-remitting multiple sclerosis (RRMS).Objective: To compare clinical outcomes after escalation to fingolimod versus natalizumab in patients with clinically active RRMS.Methods: Using the registry of the Swiss Federation for Common Tasks of Health Insurances, we identified patients with RRMS and 1 relapse in the year before switching from interferon beta or glatiramer acetate to fingolimod or natalizumab. Propensity score matching was used to select patients with comparable baseline characteristics. Relapse and Expanded Disability Status Scale (EDSS) outcomes were compared in paired, pairwise-censored analyses.Results: Of the 547 included patients, 358 were matched (fingolimod, n=179; natalizumab, n=179). Median follow-up time was 1.8years (interquartile range 0.9-2.9). Patients switching to natalizumab had a lower risk of relapses (incidence rate ratio 0.5, 95% confidence interval (CI) 0.3-0.8, p=0.001) and were more likely to experience EDSS improvement (hazard ratio (HR) 1.8, 95% CI 1.1-2.7, p=0.01) compared to fingolimod. We found no differences in the proportion of patients free from EDSS progression (HR 0.9, 95% CI 0.5-1.5, p=0.62).Conclusion: Natalizumab seems to be more effective in reducing relapse rate and improving disability compared with fingolimod.