Real-World Use of Fingolimod in Patients with Relapsing Remitting Multiple Sclerosis: A Retrospective Study Using the National Multiple Sclerosis Registry in Kuwait
Real-World Use of Fingolimod in Patients with Relapsing Remitting Multiple Sclerosis: A Retrospective Study Using the National Multiple Sclerosis Registry in Kuwait
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DOI：
10.1007/s40263-014-0185-z
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发表时间：
2014-09-01
期刊：
影响因子：
6
通讯作者：
Alroughani, Raed
中科院分区：
文献类型：
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作者：
AL-Hashel, Jasem;Ahmed, Samar F.;Alroughani, Raed
芬戈莫德是一种口服鞘氨醇-1-磷酸受体调节剂，已在临床试验中证明有效，最近已在科威特获批用于多发性硬化症（MS）治疗。上市后研究对于证明真实生活中的疗效和安全性非常重要。本研究的目的是在临床环境中检查芬戈莫德治疗的疗效和安全性。使用国家科威特MS登记处，回顾性确定了已处方芬戈莫德的复发缓解型MS患者，剂量为每千日元1份6个月。进行了3个月的临床评价和6个月的磁共振成像（MRI）。使用卡方检验和Student t检验比较治疗前和治疗后的患者状态。共纳入175例患者：75.4%女性（n = 132）;平均年龄33.3 +/- A 9.2岁;平均病程7.2 +/- A 5.2年;平均芬戈莫德使用21.7 +/- A 9.1个月。大多数患者既往使用过疾病缓解治疗（78.9%; n = 138），主要是干扰素（66.9%; n = 117）。23例患者（11.4%）停用/停用芬戈莫德;其中8例复发。无复发患者的比例显著改善（86.3%对32.6%; p < 0.001），而MRI活动患者的比例下降（18.3.6%对77.7%; p < 0.001）。与治疗前相比，末次访视时的平均扩展残疾状态量表（EDSS）评分改善（2.26 +/- A 1.49 vs. 2.60 +/- A 1.44; p = 0.03）。43例（24.6%）患者出现不良事件;头痛和淋巴细胞减少是最常见的不良事件。芬戈莫德治疗与复发和MRI活动减少以及EDSS评分改善相关。停药/退出率和不良事件发生率较低。芬戈莫德在科威特为MS提供了一种有希望的治疗方法。
Fingolimod is an oral sphingosine-1-phosphate-receptor modulator, which has demonstrated efficacy in clinical trials and has recently been approved for multiple sclerosis (MS) treatment in Kuwait. Post-marketing studies are important to demonstrate real-life efficacy and safety.The objective of this study was to examine the efficacy and safety of fingolimod treatment in a clinical setting.Using the national Kuwait MS registry, relapsing remitting MS patients who had been prescribed fingolimod for a parts per thousand yen6 months were retrospectively identified. Three-monthly clinical evaluations and 6-monthly magnetic resonance imagings (MRIs) were performed. Patient status pre- and post-treatment was compared using chi-square and Student t-tests.A total of 175 patients were included: 75.4 % female (n = 132); mean age 33.3 +/- A 9.2 years; mean disease duration 7.2 +/- A 5.2 years; mean fingolimod use 21.7 +/- A 9.1 months. Most had used previous disease-modifying therapy (78.9 %; n = 138), mainly interferons (66.9 %; n = 117). Twenty-three patients (11.4 %) discontinued/withdrew fingolimod; of whom eight had relapses. The proportion of relapse-free patients improved significantly (86.3 % vs. 32.6 %; p < 0.001), while the proportion of patients with MRI activity decreased (18.3.6 % vs. 77.7 %; p < 0.001). Mean expanded disability status scale (EDSS) score at the last visit improved when compared with pre-treatment (2.26 +/- A 1.49 vs. 2.60 +/- A 1.44; p = 0.03). Forty-three (24.6 %) patients experienced adverse events; headaches and lymphopenia were the most commonly reported adverse events.Fingolimod treatment was associated with reduced relapse and MRI activity, and an improved EDSS score. Discontinuation/withdrawal rates and adverse events were low. Fingolimod presents a promising treatment for MS in Kuwait.