慢性斑块性牛皮患者的口服庞西莫德:一个随机,双盲,安慰剂控制的第二阶段试验
Andrea Vaclavkova1, Sergio Chimenti2, Petr Arenberger3
1Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Lancet (London, England)
|August 16, 2014
概括
西莫德在治疗中度至重度慢性斑块性牛皮方面表现出显著的疗效,随着持续的维持治疗,益处增加. 这种口服治疗在牛皮区域和严重性指数得分上显示出显著的改善.
科学领域:
- 皮肤病学 皮肤病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 尼西莫德是一种口服,选择性,可逆调节器的sphingosine 1-酸盐受体1.
- 慢性斑块牛皮是一种严重的皮肤病,需要有效的治疗.
研究的目的:
- 评估ponesimod在中度至重度慢性斑块牛皮患者的疗效,安全性和耐受性.
- 评估ponesimod.com的剂量依赖性影响和维持治疗结果.
主要方法:
- 这是一项多中心,双盲的第二阶段研究,涉及326名牛皮患者.
- 患者每天服用20毫克或40毫克ponesimod或安慰剂,持续16周.
- 一部分患者在PASI得分下降了50%,进入了28周的维持期.
主要成果:
- 西莫德在第16周在46.0% (20毫克) 和48.1% (40毫克) 的患者中实现了统计学上显著的牛皮区域和严重性指数75% (PASI75) 降低,而安慰剂组为13.4%.
- 在第28周,用ponesimod的维持疗法在71.4%和77.4%的患者中维持了PASI75.
- 副作用包括呼吸不良,肝酶升高和头.
结论:
- 西莫德对慢性斑块性牛皮有显著的临床益处,在第16周就显而易见.
- 使用ponesimod的维持疗法导致持续和提高疗效.
- 尼西莫德是牛皮的潜在治疗选择,具有可管理的安全性.
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