Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Switzerland.
Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
Mult Scler. 2018 Feb;24(2):167-174. doi: 10.1177/1352458517694089. Epub 2017 Feb 1.
To investigate the efficacy and safety of fingolimod (FTY) 0.5 mg administered every other day (FTY-EOD) compared to every day (FTY-ED) in multiple sclerosis patients.
Multicentre retrospective observational study. Clinical, laboratory and neuroimaging data were consecutively collected from 60 FTY-EOD and 63 FTY-ED patients. Baseline characteristics were compared using logistic regression. Efficacy in preventing occurrence of relapses and demyelinating lesions was tested using propensity score-adjusted Cox and linear regressions.
Weight was inversely associated with risk of switch to FTY-EOD because of any reason (odds ratio (OR) = 0.94, 95% confidence interval (95% CI) = 0.89-0.99, p = 0.026), and female sex and lower baseline lymphocyte count were positively associated with switch because of lymphopenia. Compared to FTY-ED patients, FTY-EOD patients were at higher risk of developing relapses (hazard ratio (HR) = 2.98, 95% CI = 1.07-8.27, p = 0.036) and either relapses or new magnetic resonance imaging (MRI) demyelinating lesions (combined outcome, HR = 2.07, 95% CI = 1.06-4.08, p = 0.034). Within FTY-EOD, treatment with natalizumab before FTY and lower age were positively associated with risk of developing relapses and combined outcome, respectively (HR = 25.71, 95% CI = 3.03-217.57, p = 0.002 and HR = 0.85, 95% CI = 0.77-0.96, p = 0.005). FTY-EOD was overall well tolerated.
Disease reactivation was observed in a significant proportion of patients treated with FTY-EOD. Neurologists should be cautious when reducing FTY administration to every other day, especially in younger patients and those previously treated with natalizumab.
研究隔日给予芬戈莫德（FTY）0.5mg（FTY-EOD）与每日给予 FTY（FTY-ED）相比在多发性硬化症患者中的疗效和安全性。
多中心回顾性观察性研究。连续收集 60 例 FTY-EOD 和 63 例 FTY-ED 患者的临床、实验室和神经影像学数据。使用逻辑回归比较基线特征。使用倾向评分调整的 Cox 和线性回归测试预防复发和脱髓鞘病变发生的疗效。
体重与因任何原因转换为 FTY-EOD 的风险呈负相关（比值比（OR）=0.94，95%置信区间（95%CI）=0.89-0.99，p=0.026），女性和较低的基线淋巴细胞计数与因淋巴细胞减少而转换呈正相关。与 FTY-ED 患者相比，FTY-EOD 患者发生复发的风险更高（风险比（HR）=2.98，95%CI=1.07-8.27，p=0.036）和出现复发或新的磁共振成像（MRI）脱髓鞘病变（联合结局，HR=2.07，95%CI=1.06-4.08，p=0.034）。在 FTY-EOD 中，在开始 FTY 治疗之前接受那他珠单抗治疗和年龄较低与发生复发和联合结局的风险呈正相关（HR=25.71，95%CI=3.03-217.57，p=0.002 和 HR=0.85，95%CI=0.77-0.96，p=0.005）。FTY-EOD 总体耐受性良好。
在接受 FTY-EOD 治疗的患者中，观察到疾病再激活的比例较高。当将 FTY 给药减少至隔日一次时，神经科医生应谨慎，特别是在年轻患者和那些之前接受那他珠单抗治疗的患者中。
