Fingolimod in relapsing multiple sclerosis: An integrated analysis of safety findings
Fingolimod in relapsing multiple sclerosis: An integrated analysis of safety findings
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DOI：
10.1016/j.msard.2014.03.002
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发表时间：
2014-07-01
影响因子：
4
通讯作者：
Francis, Gordon
中科院分区：
文献类型：
--
作者：
Kappos, Ludwig;Cohen, Jeffrey;Francis, Gordon
背景：芬戈莫德0.5 mg每日一次是第一个被批准用于复发性多发性硬化症（MS）的口服治疗药物。目的：报告2/3期芬戈莫德研究的综合长期安全性数据。方法：描述性安全性数据来自FTY720研究评估多发性硬化症每日口服治疗的效果（freedom）研究，这是一项为期24个月的随机双盲研究，比较了0.5 mg和1.25 mg fingolimod与安慰剂，以及一个All研究组（在2/3期研究和相关扩展中接受fingolimod 0.5 mg （n=1640）或1.25-0.5 mg （n=1776）的患者）。包括截至2011年12月的相关上市后经验。结果：不良事件（ae）和严重ae （sae）的发生率与芬戈莫德和安慰剂相似。在All研究组中，fingolimod us mg与一过性、罕见症状（0.5%）、治疗开始时心动过缓和二度房室传导阻滞、轻微血压升高、频繁（9%）但通常无症状的肝酶升高和黄斑水肿（0.4%）相关。感染（包括严重感染和疱疹感染）、恶性肿瘤、急性呼吸道感染和因急性呼吸道感染而中断治疗的发生率与0.5 mg芬戈莫德和安慰剂相似。结论：在这个大型联合试验人群中，芬戈莫德的安全性得到了很好的描述。虽然可能发生罕见的SAEs，但与安慰剂相比，感染、恶性肿瘤或严重心血管事件的风险没有增加。(C) 2014年Elsevier B.V.出版
Background: Fingolimod 0.5 mg once daily is the first approved oral therapy for relapsing multiple sclerosis (MS).Objective: To report integrated long-term safety data from phase 2/3 fingolimod studies.Methods: Descriptive safety data are reported from the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study, a 24-month, randomized, double-blind study comparing fingolimod 0.5 mg and 1.25 mg with placebo, and an All Studies group (patients who received fingolimod 0.5 mg (n=1640) or 1.25-0.5 mg (n=1776) in phase 2/3 studies and associated extensions). Relevant post-marketing experience, up to December 2011, is included.Results: The incidence of adverse events (AEs) and serious AEs (SAEs) was similar with fingolimod and placebo in FREEDOMS. In the All Studies group, fingolimod U.S mg was associated with transient, rarely symptomatic (0.5%), bradycardia and second-degree atrioventricular block on treatment initiation, minor blood pressure increases, frequent (9%) but generally asymptomatic liver enzyme elevations, and macular oedema (0.4%). The incidences of infections (including serious and herpes infections), malignancies, SAEs and treatment discontinuations due to AEs were similar with fingolimod 0.5 mg and placebo.Conclusion: The safety profile of fingolimod has been well characterized in this large combined trial population. Although infrequent SAEs can occur, there is no increased risk of infections, malignancies or serious cardiovascular events versus placebo. (C) 2014 Published by Elsevier B.V.