Department of Neurology, Faculty of General Medicine, Albert Szent-Györgyi Clinical Centre, University of Szeged, Szeged, Hungary.
Department of Neurology, Faculty of General Medicine, University of Pécs, Pécs, Hungary.
PLoS One. 2022 Apr 22;17(4):e0267346. doi: 10.1371/journal.pone.0267346. eCollection 2022.
Fingolimod was approved and reimbursed by the healthcare provider in Hungary for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS) in 2012. The present study aimed to assess the effectiveness, safety profile, and persistence to fingolimod in a real-life setting in Hungary in RRMS patients who were either therapy naïve before enrollment or have changed to fingolimod from another disease-modifying therapy (DMT) for any reason.
This cross-sectional, observational study with prospective data collection was performed nationwide at 21 sites across Hungary. To avoid selection bias, sites were asked to document eligible patients in consecutive chronological order. Demographic, clinical, safety and efficacy data were analysed for up to 5 years from 570 consenting adult patients with RRMS who had received treatment with fingolimod for at least one year.
69.6% of patients remained free from relapses for the whole study duration; in the first year, 85.1% of patients did not experience a relapse, which rose to 94.6% seen in the 5th year. Compared to baseline at study end, 28.2% had higher, and 9.1% had lower, meanwhile, 62.7% of the patients had stable EDSS scores. Overall, the annualized relapse rate decreased from 0.804 observed at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (77.0%, 82.1%, 85.2%, 89.7%, and 89.0% relative reduction, respectively) after 1, 2, 3, 4, and 5 years of treatment. The greatest reduction rate was seen in the group of therapy naïve patients. Treatment persistence on fingolimod after 60 months was 73.4%.
In this nationwide Hungarian cohort, most patients under fingolimod treatment were free from relapses and disability progression. In addition, fingolimod has proven to be a well-tolerated DMT that has sustained its manageable safety profile, high efficacy, and positive benefit/risk ratio for up to 5 years in a real-life setting.
2012 年，匈牙利的医疗保健提供者批准并报销了芬戈莫德用于治疗活跃的复发缓解型多发性硬化症（RRMS）。本研究旨在评估在匈牙利真实环境中，RRMS 患者使用芬戈莫德治疗的有效性、安全性概况和持续性，这些患者在入组前要么未经治疗，要么因任何原因从另一种疾病修正治疗（DMT）转为芬戈莫德。
这是一项全国性的、观察性的、前瞻性数据收集的横截面研究，在匈牙利的 21 个地点进行。为了避免选择偏倚，要求各地点按连续时间顺序记录合格患者。对 570 名连续同意接受至少一年芬戈莫德治疗的 RRMS 成年患者的人口统计学、临床、安全性和疗效数据进行了长达 5 年的分析。
69.6%的患者在整个研究期间无复发；第一年，85.1%的患者无复发，第 5 年时上升至 94.6%。与研究结束时的基线相比，28.2%的患者 EDSS 评分更高，9.1%的患者 EDSS 评分更低，同时，62.7%的患者 EDSS 评分稳定。总体而言，年复发率从基线时的 0.804 降至 0.185、0.149、0.122、0.091 和 0.097（分别为 77.0%、82.1%、85.2%、89.7%和 89.0%的相对减少），治疗 1、2、3、4 和 5 年后。在未经治疗的患者中，治疗效果的降幅最大。60 个月后，继续使用芬戈莫德治疗的比例为 73.4%。
在这项全国性的匈牙利队列研究中，大多数接受芬戈莫德治疗的患者无复发且残疾进展。此外，芬戈莫德已被证明是一种耐受性良好的 DMT，在真实环境中，5 年内疗效持续，安全性可控，疗效高，具有良好的获益/风险比。
