Karadeniz Technical University, Department of Neurology, 61080, Trabzon, Turkey.
Ondokuz Mayis University, Department of Neurology, Samsun, Turkey.
Mult Scler Relat Disord. 2019 Nov;36:101376. doi: 10.1016/j.msard.2019.101376. Epub 2019 Aug 26.
Fingolimod and teriflunomide are commonly used in the treatment of relapsing-remitting multiple sclerosis (RRMS). These have not been compared in controlled trials, but only in observational studies, with inconclusive results. Comparison of their effect on relapse and disability in a real-world setting is therefore needed.
The objective of this study was to compare the efficacy of fingolimod and teriflunomide in reducing disease activity in RRMS.
This multicenter, retrospective observational study was carried out with prospectively collected data from 15 centers. All consecutive RRMS patients treated with teriflunomide or fingolimod were included. Data for relapses, Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging (MRI) scans were collected. Patients were matched using propensity scores. Annualized relapse rates (ARR), disability accumulation, percentage of patients with active MRI and treatment discontinuation over a median 2.5-year follow-up period were compared.
Propensity score matching retained 349 out of 1388 patients in the fingolimod group and 349 out 678 in the teriflunomide group for final analyses. Mean ARR decreased markedly from baseline after 1 and 2 years of treatment in both the fingolimod (0.58-0.17 after 1 year and 0.11 after 2 years, p < 0.001) and teriflunomide (0.56-0.29 after 1 year and 0.31 after 2 years, p < 0.001) groups. Mean ARR was lower in fingolimod-treated patients than in those treated with teriflunomide at years 1 (p = 0.02) and 2 (p = 0.004). Compared to teriflunomide, the fingolimod group exhibited a higher percentage of relapse-free patients and a lower percentage of MRI-active patients after 2.5-year follow-up. Disability worsening was similar between the two groups. Patients were less likely to discontinue fingolimod than teriflunomide (p < 0.001).
Fingolimod was associated with a better relapse control and lower discontinuation rate than teriflunomide. The two oral therapies exhibited similar effects on disability outcomes.
芬戈莫德和特立氟胺常用于治疗复发缓解型多发性硬化症（RRMS）。这两种药物尚未在对照试验中进行比较，仅在观察性研究中进行了比较，结果尚无定论。因此，需要在真实环境中比较它们对复发和残疾的影响。
本研究旨在比较芬戈莫德和特立氟胺在降低 RRMS 疾病活动度方面的疗效。
这是一项多中心、回顾性观察性研究，对 15 个中心前瞻性收集的数据进行了研究。所有接受特立氟胺或芬戈莫德治疗的连续 RRMS 患者均纳入研究。收集了复发、扩展残疾状态量表（EDSS）评分和脑磁共振成像（MRI）扫描的数据。采用倾向评分进行匹配。比较了中位随访 2.5 年后的年化复发率（ARR）、残疾累积、有活动 MRI 的患者比例和治疗中断率。
倾向评分匹配保留了芬戈莫德组 1388 例患者中的 349 例和特立氟胺组 678 例患者中的 349 例进行最终分析。在芬戈莫德（治疗 1 年后 0.58-0.17，治疗 2 年后 0.11，p<0.001）和特立氟胺（治疗 1 年后 0.56-0.29，治疗 2 年后 0.31，p<0.001）组，治疗 1 年和 2 年后 ARR 均明显低于基线。在治疗 1 年（p=0.02）和 2 年（p=0.004）时，接受芬戈莫德治疗的患者的 ARR 均低于接受特立氟胺治疗的患者。与特立氟胺相比，在 2.5 年随访后，芬戈莫德组无复发患者的比例更高，MRI 阳性患者的比例更低。两组残疾恶化情况相似。芬戈莫德组患者停药率低于特立氟胺组（p<0.001）。
与特立氟胺相比，芬戈莫德治疗 RRMS 患者时的复发控制效果更好，停药率更低。两种口服药物在残疾结局方面的效果相似。
