Neurologic Clinic and Policlinic, Department of Neurology, University Hospital Basel, Basel, Switzerland.
Clinical Trial Unit, University Hospital Basel, Basel, Switzerland.
Mult Scler. 2018 May;24(6):777-785. doi: 10.1177/1352458518768433. Epub 2018 Apr 24.
No randomized controlled trials have compared the efficacy of fingolimod or natalizumab as second-line treatment in patients with relapsing-remitting multiple sclerosis (RRMS).
To compare clinical outcomes after escalation to fingolimod versus natalizumab in patients with clinically active RRMS.
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.
Of the 547 included patients, 358 were matched (fingolimod, n = 179; natalizumab, n = 179). Median follow-up time was 1.8 years (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).
Natalizumab seems to be more effective in reducing relapse rate and improving disability compared with fingolimod.
尚无随机对照试验比较那他珠单抗或芬戈莫德作为复发缓解型多发性硬化（RRMS）二线治疗的疗效。
比较临床活动型 RRMS 患者升级为芬戈莫德或那他珠单抗后的临床结局。
利用瑞士联邦医疗保险共同任务登记处，我们鉴定了在从干扰素β或那他珠单抗转换为芬戈莫德或那他珠单抗前 1 年有≥1 次复发的 RRMS 患者。采用倾向评分匹配选择基线特征可比的患者。在配对、成对删失分析中比较了复发和扩展残疾状态量表（EDSS）结局。
547 例纳入患者中，358 例匹配（芬戈莫德组，n = 179；那他珠单抗组，n = 179）。中位随访时间为 1.8 年（四分位间距 0.9-2.9）。转换用那他珠单抗的患者复发风险较低（发病率比 0.5，95%置信区间 0.3-0.8，p = 0.001），且更可能出现 EDSS 改善（风险比 1.8，95%置信区间 1.1-2.7，p = 0.01）。我们未发现两组无 EDSS 进展患者的比例有差异（风险比 0.9，95%置信区间 0.5-1.5，p = 0.62）。
与芬戈莫德相比，那他珠单抗似乎能更有效地降低复发率和改善残疾。
