针对性口服Icotrokinra对于涉及高影响部位的牛皮
Melinda Gooderham1, Edward Lain2, Robert Bissonnette3
1SKiN Centre for Dermatology, Department of Medicine at Queen's University and Probity Medical Research, Peterborough, ON, Canada.
NEJM evidence
|November 5, 2025
概括
在第三阶段试验中,Icotrokinra显著改善了高影响部位的斑块性牛皮,包括头皮和生殖器部位. 与安慰剂相比,这种向性口服在16周内显示出更高的清除率.
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:
- 影响高冲击部位的斑块牛皮会带来重大治疗挑战.
- Icotrokinra是一种口服胺,向互白素-23受体,正在对这种情况进行研究.
研究的目的:
- 为了评估icotrokinra在患有斑块性牛皮的患者的疗效和安全性,涉及高冲击部位.
主要方法:
- 一个第三阶段的双盲,安慰剂对照试验随机选择了311名患有斑块性牛皮的参与者 (≥12年) 接受icotrokinra (每天200毫克) 或安慰剂 (2:1比率).
- 主要终点是参与者在16周内获得0或1的调查员全球评估 (IGA) 评分的比例.
- 二级终点包括头皮,生殖器,手和脚上的牛皮的清除.
主要成果:
- 56.7%的Icotrokinra接受者达到IGA0或1与5.8%的安慰剂相比 (P<0.001).
- 在头皮 (65.9% vs 10.6%) 和生殖器 (76.5% vs 21.4%) 牛皮的显著改善被观察到.
- 对于手足牛皮 (41.7%与26.1%) 没有发现显著差异.
- 在50%的icotrokinra使用者和42%的安慰剂使用者中报告了不良事件.
结论:
- 伊科特罗金拉在16周治疗整体皮肤,头皮和生殖器区域的斑块牛皮疹方面表现出显著的疗效.
- 该疗法对影响手脚的牛皮没有显著的疗效.
- 在研究期间,没有发现安全问题.
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