Neurology Department, Hospital Uniersitario San Cecilio de Granada, Granada, Spain.
Neurology Department, Hospital General Universitario de Elda, Alicante, Spain.
PLoS One. 2020 Apr 2;15(4):e0230846. doi: 10.1371/journal.pone.0230846. eCollection 2020.
The 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.
This 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.
The 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 naïve 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<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%.
The subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting.
本研究旨在描述在西班牙接受芬戈莫德治疗的 RRMS 患者的人口统计学和临床特征，并评估药物在临床实践中的有效性和安全性。
这是一项在西班牙 56 家医院进行的观察性、回顾性、多中心、全国性研究，共纳入 804 例自 2011 年 11 月起接受口服芬戈莫德（0.5mg）治疗的 RRMS 患者，其最低随访时间为 12 个月。
在接受芬戈莫德治疗前的 1 年中，平均年复发率（ARR）为 1.08，中位数扩展残疾状况量表（EDSS）为 3；患者平均接受芬戈莫德治疗 2.2 年；基线时超过一半的患者 MRI 显示病灶数>20。患者之前接受过一线注射型 DMT（60.3%）、那他珠单抗（31.3%）治疗，8.3%为初治患者。总体而言，治疗后 12、24 和 36 个月时，ARR 分别显著降低至 0.28、0.22 和 0.17（相对减少 74.1%、79.7%和 83.5%），P<0.001。从那他珠单抗转为芬戈莫德治疗的患者的 ARR 在研究期间保持稳定。24 个月后，大多数患者（88.7%）未出现确诊残疾和 MRI 活动（67.3%）。芬戈莫德治疗 12 个月后的持续率为 93.9%。
分析的患者亚组显示出不同的基线人口统计学和临床特征。对接受常规临床实践中芬戈莫德治疗的患者的分析证实了该药具有足够的疗效和安全性，即使是长期治疗也是如此。本研究数据还证实了在真实世界临床实践环境中，芬戈莫德具有良好的获益/风险平衡。
