Gajofatto Alberto, Turatti Marco, Monaco Salvatore, Benedetti Maria Donata
Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy ; Division of Neurology B, Verona University Hospital, Verona, Italy.
Division of Neurology B, Verona University Hospital, Verona, Italy.
Drug Healthc Patient Saf. 2015 Dec 11;7:157-67. doi: 10.2147/DHPS.S69640. eCollection 2015.
Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS), a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-β1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management.
芬戈莫德是一种选择性免疫抑制剂，在全球范围内被批准用于治疗复发缓解型多发性硬化症（MS），这是一种慢性且可能导致残疾的神经系统疾病。随机双盲临床试验表明，与安慰剂和肌肉注射干扰素-β1a相比，芬戈莫德显著降低复发率，并改善了多项脑部MRI指标，包括脑萎缩。对残疾进展的影响仍存在争议，因为一项III期试验显示治疗有显著益处，而另外两项试验则未显示。尽管芬戈莫德每日口服给药非常方便，但严重心脏、眼部、感染及其他罕见不良事件的可能性，证明了欧洲药品管理局将该药物批准为对一线治疗无反应或病程快速进展的MS患者的二线治疗药物这一决定是合理的。在美国，芬戈莫德则被批准为一线治疗药物。本综述的目的是描述和讨论芬戈莫德在多发性硬化症管理临床背景下的疗效、安全性和耐受性特征。
