在中度至重度斑块性牛皮 (IMMvent) 患者中与阿达利木马布进行比较:随机,双盲,主动对比控制的第三期试验
Kristian Reich1, Melinda Gooderham2, Diamant Thaçi3
1Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation Center, Hamburg, Germany.
Lancet (London, England)
|July 9, 2019
概括
瑞桑基祖马布在中度至重度的斑块性牛皮症中表现出比阿达利穆马布更高的疗效,皮肤清除率更高. 没有出现新的安全问题,为牛皮患者提供了灵活的治疗选择.
科学领域:
- 皮肤病学
- 免疫学
- 临床试验
背景情况:
- 牛皮是一种普遍的自身免疫性疾病,
- 抗细胞因子治疗可以缓解牛皮的症状.
- 中度至重度的斑块性牛皮需要有效的治疗方案.
研究的目的:
- 在中度至重度斑块性牛皮患者中比较risankizumab与adalimumab的疗效和安全性.
- 在第16周和第44周评估皮肤清除和临床反应.
主要方法:
- 第三阶段,随机,双盲,主控IMMvent试验.
- 在16周内服用150毫克的瑞桑基祖马布和40毫克的阿达利穆马布 (A部分).
- 适合继续或转换为瑞桑基祖马布的患者重新随机化 (B部分).
主要成果:
- 在第16周,risankizumab获得了显著更高的PASI 90 (72%对47%) 和sPGA 0/1 (84%对60%).
- 在B部分,转换为risankizumab改善了PASI 90反应 (66%对21%).
- 在risankizumab和adalimumab组中观察到类似的不良事件发生率.
结论:
- 与阿达利穆马布相比,瑞桑基祖马布在斑块性牛皮的治疗中具有更高的皮肤清除能力.
- 从阿达利木马布转换为瑞桑基祖马布可以改善治疗效果.
- 瑞桑基祖马布是长期治疗牛皮的安全和灵活选择.
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