中东和北非复发性缓解型多发性硬化症患者中 FINgOlimod 的有效性和安全性的真实世界回顾性研究（FINOMENA）。
Real-world retrospective study of effectiveness and safety of FINgOlimod in relapsing remitting multiple sclerosis in the Middle East and North Africa (FINOMENA).
机构信息
Ibn Sina Hospital, Kuwait.
Kingdom Hospital, Saudi Arabia.
出版信息
Clin Neurol Neurosurg. 2021 Apr;203:106576. doi: 10.1016/j.clineuro.2021.106576. Epub 2021 Feb 25.
OBJECTIVES
Evidence on the effectiveness and safety of fingolimod in real-world clinical practice in the Middle East and North African (MENA) region is limited. This study aimed to evaluate the effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) in real-world setting in the MENA region.
PATIENTS AND METHODS
RRMS patients who had been treated with fingolimod for at least 12 months were retrospectively identified from the databases of 34 centers across the MENA region. Study outcomes included the annualized relapse rate (ARR), relapse-free rate (RFR), time to first and second relapses, mean change in Expanded Disability Status Scale (EDSS), proportion of patients with Magnetic Resonance Imaging (MRI) activity and no evidence of disease activity (NEDA)-3, retention of patients on treatment, as well as all safety measures.
RESULTS
A total of 806 patients were included: 66.34 % female; mean age 32.97 ± 9.62 years; mean disease duration 4.92 ± 4.66 years; mean fingolimod use 37.2 ± 16.7 months. Most patients had received previous disease-modifying therapy (79.65 %). Compared to the year preceding fingolimod initiation, RFR improved (33.00%-86.35%; p < 0.001), ARR decreased (0.84 ± 0.73 to 0.16 ± 0.45; p = 0.005), EDSS decreased (2.69 ± 1.74-2.01 ± 1.66; p < 0.001), and the proportion of patients with Gadolinium-enhancing T1 lesions decreased (57.84 % to 12.93 %; p < 0.001), after 12 months of fingolimod treatment. NEDA-3 was achieved in 41.3 % of patients. Median time to first and second relapses was not reached since 86.35 % and 98.39 % of patients had not experienced relapses for the first time and second time, respectively. Eight-hundred one (99.38 %) patients continued fingolimod treatment beyond 12 months. One-hundred thirty patients (16.13 %) experienced adverse events, mainly lymphopenia (5.46 %) and leukopenia (2.11 %), while 13 patients (1.61 %) experienced serious adverse events.
CONCLUSION
This study confirms the effectiveness and safety profile of fingolimod in real-world setting in the Middle East and North African (MENA) region.
目的
在中东和北非（MENA）地区，有关芬戈莫德在真实临床实践中的疗效和安全性的证据有限。本研究旨在评估 MENA 地区真实环境中使用芬戈莫德治疗复发缓解型多发性硬化症（RRMS）患者的疗效和安全性。
方法
从 MENA 地区 34 个中心的数据库中回顾性确定至少接受了 12 个月芬戈莫德治疗的 RRMS 患者。研究结果包括年复发率（ARR）、无复发率（RFR）、首次和第二次复发的时间、扩展残疾状况量表（EDSS）的平均变化、磁共振成像（MRI）活动和无疾病活动证据（NEDA）-3 的患者比例、治疗保留率以及所有安全性措施。
结果
共纳入 806 例患者：66.34%为女性；平均年龄 32.97±9.62 岁；平均病程 4.92±4.66 年；平均使用芬戈莫德 37.2±16.7 个月。大多数患者接受过先前的疾病修正治疗（79.65%）。与开始使用芬戈莫德之前的一年相比，RFR 提高（33.00%-86.35%；p<0.001），ARR 降低（0.84±0.73 至 0.16±0.45；p=0.005），EDSS 降低（2.69±1.74 至 2.01±1.66；p<0.001），且钆增强 T1 病变的患者比例降低（57.84%至 12.93%；p<0.001），接受 12 个月的芬戈莫德治疗后。41.3%的患者达到了 NEDA-3。首次和第二次复发的中位时间尚未达到，因为 86.35%和 98.39%的患者首次和第二次均未复发。801 例（99.38%）患者在 12 个月后继续接受芬戈莫德治疗。130 例（16.13%）患者出现不良事件，主要为淋巴细胞减少症（5.46%）和白细胞减少症（2.11%），13 例（1.61%）患者出现严重不良事件。
结论
本研究证实了芬戈莫德在 MENA 地区真实环境中的疗效和安全性。
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