适度至重症牛皮的因弗利西马布诱导和维持疗法:一个III期,多中心,双盲试验
Kristian Reich1, Frank O Nestle, Kim Papp
1Department of Dermatology, Georg-August University, Göttingen, Germany.
Lancet (London, England)
|October 18, 2005
概括
恩弗利西马布有效治疗中度至重度的牛皮,80%的患者在10周内获得显著的皮肤改善. 使用这种TNFαα抑制剂的持续治疗表明持续有效性和良好的耐受性超过一年.
科学领域:
- 免疫皮肤学 免疫皮肤学
- 临床免疫学 临床免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 瘤亡因子α (TNFalpha) 涉及到牛皮病的发生.
- 一种TNFalpha中和单克隆抗体Infliximab被研究用于牛皮的治疗.
研究的目的:
- 评估在中度至重度的斑块性牛皮患者中持续治疗infliximab的疗效和安全性.
- 评估INFLIXIMAB在1年内诱导和维持治疗中的有效性.
主要方法:
- 第三阶段,多中心,双盲试验,涉及378名中度至重度斑块性牛皮的患者.
- 患者在规定的时间间隔内接受了infliximab (5 mg/kg) 或安慰剂输液,而安慰剂患者在第24周进行了交叉输液.
- 牛皮的严重程度使用牛皮区域和严重性指数 (PASI) 和指甲牛皮严重性指数 (NAPSI) 来评估.
主要成果:
- 在第10周,80%的因弗力西马布治疗患者实现了>=75%的PASI改善 (PASI 75),而安慰剂患者的改善率为3% (p<0.0001).
- 在第50周观察到持续的疗效,其中61%的患者达到PASI 75和45%的患者达到PASI 90.
- 整体而言,infliximab的耐受性很好,这表明了良好的安全性.
结论:
- 因弗利西马布是一种有效的诱导和维持疗法,用于中度至重度的牛皮.
- 经过1年的治疗,持续PASI 75和PASI 90改善的高率得到了实现.
- 这项研究支持infliximab在管理中度至重度牛皮的作用.
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