Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis
复制标题
DOI：
10.1056/nejmoa1206328
复制
发表时间：
2012-09-20
影响因子：
158.5
通讯作者：
Dawson, Katherine T.
中科院分区：
文献类型：
--
作者：
Fox, Robert J.;Miller, David H.;Dawson, Katherine T.
研究背景BG-12（富马酸二甲酯）正在开发作为复发缓解型多发性硬化症的口服治疗，复发缓解型多发性硬化症通常用胃肠外药物（干扰素或醋酸格拉替雷）治疗。METHODS在这项3期随机研究中，我们研究了口服BG-12的有效性和安全性，剂量为240 mg，每日两次或三次，与安慰剂相比，复发缓解型多发性硬化症患者。还包括活性剂醋酸格拉替雷作为参比对照品。主要终点是2年内的年复发率。该研究的目的不是检验BG-12与醋酸格拉替雷相比的优效性或非劣效性。在2年时，BG-12每日两次（0.22）、BG-12每日三次（0.20）和醋酸格拉替雷（0.29）的年复发率显著低于安慰剂（0.40）（相对降低：BG-12每日两次，44%，P
BACKGROUNDBG-12 (dimethyl fumarate) is in development as an oral treatment for relapsing-remitting multiple sclerosis, which is commonly treated with parenteral agents (interferon or glatiramer acetate).METHODSIn this phase 3, randomized study, we investigated the efficacy and safety of oral BG-12, at a dose of 240 mg two or three times daily, as compared with placebo in patients with relapsing-remitting multiple sclerosis. An active agent, glatiramer acetate, was also included as a reference comparator. The primary end point was the annualized relapse rate over a period of 2 years. The study was not designed to test the superiority or noninferiority of BG-12 versus glatiramer acetate.RESULTSAt 2 years, the annualized relapse rate was significantly lower with twice-daily BG-12 (0.22), thrice-daily BG-12 (0.20), and glatiramer acetate (0.29) than with placebo (0.40) (relative reductions: twice-daily BG-12, 44%, P