抗MAdCAM抗体 (PF-00547659) 治疗性结肠炎 (TURANDOT):一个2期随机,双盲,安慰剂对照试验
Séverine Vermeire1, William J Sandborn2, Silvio Danese3
1Leuven University Hospital and University of Leuven, Leuven, Belgium.
针对MAdCAM-1的单克隆抗体PF- 00547659在诱导中度至重度性结肠炎的缓解方面表现出有效性. 在这种患者群体中,22.5 mg和75 mg的剂量显示出最大的临床效果.
科学领域:
- 胃肠病学
- 免疫学
- 药理学
背景情况:
- 性结肠炎是一种慢性炎症性肠病.
- 粘膜地址细胞粘附分子-1 (MAdCAM-1) 在淋巴细胞向肠道导向中起作用.
- PF- 00547659是一种针对MAdCAM-1的单克隆抗体.
研究的目的:
- 评估 PF- 00547659 在中度至重度性结肠炎患者的疗效和安全性.
- 在性结肠炎诱导治疗中确定PF- 00547659的最佳剂量.
主要方法:
- 第二阶段,随机,双盲,安慰剂对照试验.
- 357名中度至重度性结肠炎患者每4周接受安慰剂或PF- 00547659 (7. 5 mg,22. 5 mg,75 mg或225 mg) 的皮下注射.
- 主要终点:在第12周缓解.
主要成果:
- 与安慰剂相比,7. 5 mg,22. 5 mg 和 75 mg PF- 00547659 组的缓解率在第 12 周显著更高.
- 22. 5毫克和75毫克的剂量显示出最大的临床效果.
- 对于PF- 00547659在所有剂量中没有发现任何显著的安全信号.
结论:
- 在中度至重度的性结肠炎中,PF- 00547659是安全的,耐受性良好.
- 在诱导性结肠炎方面,PF- 00547659比安慰剂更有效.
- 建议使用22. 5毫克和75毫克剂量进行进一步的研究.
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