Walczak Agata, Kurkowska-Jastrzebska Iwona, Zakrzewska-Pniewska Beata, Dorobek Malgorzata, Brola Waldemar, Zajdel Radoslaw, Bartosik-Psujek Halina, Stasiolek Mariusz, Kulakowska Alina, Rusek Stanislaw, Tutaj Andrzej, Glabinski Andrzej, Wlodek Agata, Kochanowski Jan, Ciach Agnieszka, Siger Malgorzata, Kurowska Katarzyna, Wicha Wojciech, Nojszewska Monika, Podlecka-Pietowska Aleksandra, Czajka Anna, Kapica-Topczewska Katarzyna, Bielecki Bartosz, Maciagowska-Terela Marzena, Stepien Adam
Department of Neurology, Medical University of Lodz, Lodz, Poland.
2nd Department of Neurology, Institute of Psychiatry and Neurology in Warsaw, Poland.
Clin Neurol Neurosurg. 2019 Sep;184:105453. doi: 10.1016/j.clineuro.2019.105453. Epub 2019 Jul 23.
Fingolimod is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients with highly aggressive disease characterized by frequent relapses and active magnetic resonance imaging. Its efficacy has been demonstrated in three large phase III trials, used in the regulatory submissions throughout the world. Fingolimod in licensed in Europe since 2011 but with a growing number of disease-modifying drugs (DMD) becoming available for RRMS, it is important to gather real-world evidence data regarding long-term effectiveness in treated patients with MS. The aim of this study was to assess fingolimod effectiveness in a real life Polish group of RRMS patients receiving fingolimod as second line treatment.
The observational study with retrospective data collection was performed at 13 sites that were asked to document eligible patients in consecutive chronological order to avoid selection bias. Demographic and clinical data from 253 adult patients with RRMS treated with fingolimod were analyzed.
Mean treatment time with fingolimod was 42 months. Relapses reduction during 3 years treatment period was observed (2.0 v 0.2) and majority of patients were free of relapses. Mean EDSS score was stable during the time of observation. The proportion of patients who were free from any clinical disease activity, i.e. without relapses and disability progression, was over 70%. During the first and second year of observation significant reduction of new MRI lesions was observed.
In the Polish group of patients with RRMS treated with fingolimod, the majority of them showed freedom from relapses, disability progression and reduction of new MRI lesions. Switching from injectable immunomodulatory drugs to fingolimod is associated with fewer relapses and lower disability progression.
芬戈莫德适用于治疗复发缓解型多发性硬化症（RRMS）患者，这些患者病情高度侵袭性，以频繁复发和磁共振成像活跃为特征。其疗效已在三项大型III期试验中得到证实，并用于全球的监管申报。自2011年起，芬戈莫德在欧洲获得许可，但随着越来越多的疾病修饰药物（DMD）可用于RRMS，收集有关MS治疗患者长期有效性的真实世界证据数据非常重要。本研究的目的是评估芬戈莫德在波兰一组接受芬戈莫德作为二线治疗的RRMS患者中的有效性。
在13个地点进行了回顾性数据收集的观察性研究，要求按时间顺序连续记录符合条件的患者，以避免选择偏倚。分析了253例接受芬戈莫德治疗的成年RRMS患者的人口统计学和临床数据。
芬戈莫德的平均治疗时间为42个月。在3年治疗期内观察到复发减少（2.0对0.2），大多数患者无复发。在观察期间，平均扩展残疾状态量表（EDSS）评分稳定。无任何临床疾病活动（即无复发和残疾进展）的患者比例超过70%。在观察的第一年和第二年，观察到新的MRI病变显著减少。
在波兰接受芬戈莫德治疗的RRMS患者组中，大多数患者无复发、无残疾进展且新的MRI病变减少。从注射用免疫调节药物改用芬戈莫德与较少的复发和较低的残疾进展相关。
