Freedman M S, Wolinsky J S, Truffinet P, Comi G, Kappos L, Miller A E, Olsson T P, Benamor M, Chambers S, O'Connor P W
University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada.
University of Texas Health Science Center at Houston, Houston, TX, USA.
Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec.
Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS.
To evaluate the safety and tolerability of teriflunomide as add-on therapy to a stable dose of glatiramer acetate (GA) in patients with relapsing forms of MS (RMS).
Phase II, randomized, double-blind, add-on, placebo-controlled study. The primary objective was to assess safety and tolerability; secondary objectives were to evaluate effects of treatment on disease activity assessed by MRI and relapse.
Patients with RMS on GA ( = 123) were randomized 1:1:1 to receive teriflunomide 14 mg ( = 40), 7 mg ( = 42), or placebo ( = 41) for 24 weeks; 96 patients entered the 24-week extension, remaining on original treatment allocation. Teriflunomide was well tolerated over 48 weeks. The frequency of adverse events (AEs) was low across all groups; 5 (12.2%), 3 (7.1%), and 2 (5.0%) patients in the 14 mg, 7 mg, and placebo groups, respectively, discontinued treatment due to AEs. Teriflunomide reduced the number of T1-Gd lesions vs placebo (14 mg: 46.6% relative reduction, = 0.1931; 7 mg: 64.0%: relative reduction, = 0.0306).
Teriflunomide added to stable-dose GA had acceptable safety and tolerability, and reduced some MRI markers of disease activity compared with GA alone. NCT00475865 (core study); NCT00811395 (extension).
特立氟胺是一种每日一次的口服免疫调节剂，用于治疗复发缓解型多发性硬化症。
评估特立氟胺作为复发型多发性硬化症（RMS）患者稳定剂量醋酸格拉替雷（GA）附加疗法的安全性和耐受性。
II期随机双盲附加安慰剂对照研究。主要目的是评估安全性和耐受性；次要目的是评估治疗对通过磁共振成像（MRI）和复发评估的疾病活动的影响。
接受GA治疗的RMS患者（n = 123）按1:1:1随机分组，接受特立氟胺14mg（n = 40）、7mg（n = 42）或安慰剂（n = 41）治疗24周；96名患者进入24周延长期，维持原治疗分配。特立氟胺在48周内耐受性良好。所有组不良事件（AE）的发生率都很低；14mg、7mg和安慰剂组分别有5名（12.2%）、3名（7.1%）和2名（5.0%）患者因AE停药。与安慰剂相比，特立氟胺减少了T1加权钆增强病灶的数量（14mg：相对减少46.6%，P = 0.1931；7mg：相对减少64.0%，P = 0.0306）。
在稳定剂量的GA基础上加用特立氟胺具有可接受的安全性和耐受性，与单独使用GA相比，减少了一些疾病活动的MRI标志物。NCT00475865（核心研究）；NCT00811395（延长期）。
