Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
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DOI：
10.1371/journal.pone.0230846
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发表时间：
2020-04-02
期刊：
影响因子：
3.7
通讯作者：
Jose Moreno, Maria
中科院分区：
文献类型：
--
作者：
Barrero, Francisco;Mallada-Frechin, Javier;Jose Moreno, Maria
PurposeThe的目的，这项研究的目的是表征RRMS患者接受芬戈莫德在西班牙的人口和临床概况，并评估药物的有效性和安全性在临床practice.MethodsThis观察，回顾性，多中心，全国范围内的研究进行了56家西班牙医院，涉及804 RRMS患者谁接受口服芬戈莫德结果芬戈莫德治疗前一年的平均年复发率（ARR）为1.08，EDSS中位数为3，患者平均暴露于芬戈莫德2.2年;关于磁共振成像（MRI）活动，超过一半的患者在基线时具有> 20个病变。患者既往接受过一线注射DMT（60.3%）或那他珠单抗（31.3%）治疗，8.3%为初治患者。总体而言，在治疗12、24和36个月后，ARR显著降低至0.28、0.22和0.17（分别为相对降低的74.1%、79.7%和83.5%），P
PurposeThe objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice.MethodsThis observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months.ResultsThe mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had > 20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naive patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P