青少年异常性关节炎儿童的阿巴塞普:一个随机,双盲,安慰剂控制的戒断试验
Nicolino Ruperto1, Daniel J Lovell, Pierre Quartier
1IRCCS G Gaslini, PRINTO, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
Lancet (London, England)
|July 18, 2008
概括
阿巴塞普显著减少了青少年异常性关节炎 (JIA) 的儿童的关节炎发作,这些儿童对其他治疗没有反应. 这种选择性T细胞成本刺激调节器为管理耐火性JIA提供了安全有效的替代方案.
科学领域:
- 儿科风湿病学 儿科风湿病学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 青春期异常性关节炎 (JIA) 带来了治疗挑战,一些儿童对常规修饰疾病的抗风湿药物 (DMARD) 没有反应或不耐受,包括抗瘤坏死因子 (TNF) 药物.
- 选择性T细胞共刺激调节剂阿巴cept为这些难以治疗的病例提供了潜在的治疗选择.
研究的目的:
- 为了评估阿巴塔塞普特在被诊断为JIA的儿科患者的安全性和疗效,这些患者之前已经失败了其他治疗.
- 为了确定阿巴切是否可以预防或延迟这种特定患者群体中关节炎的爆发.
主要方法:
- 一个双盲,随机控制的戒断试验,涉及190名儿童 (年龄在6-17岁) 患有活跃的JIA并且对以前的DMARDs反应不足.
- 患者接受了4个月的开放标签阿巴特塞普,然后随机选择继续接受阿巴特塞普或接受安慰剂6个月,以时间为主要终点.
主要成果:
- 在双盲阶段 (p = 0.0003) 发生的关节炎发作显著减少,与安慰剂 (53%) 相比,在阿巴cept组 (20%) 发生了较少的关节炎发作.
- 继续服用阿巴cept的患者中,发作风险降低了三分之二以上 (危险比率为0.31).
- 两组之间不良事件的发生频率相似,严重不良事件没有显著差异.
结论:
- 选择性T细胞共刺激调节与阿巴塔塞普是一个可行的和有效的替代治疗儿童与JIA.
- 阿巴塔塞普在患有耐火性JIA的儿科患者群体中显示出有利的安全性和疗效.
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