在中度至重度慢性斑块性牛皮患者中,CT-P17和欧盟基准阿达利木马布之间的重复切换:随机,双盲,主动控制,第三阶段,可互换性研究
Mark G Lebwohl1, John Y Koo2, Janusz Jaworski3
1Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Advances in therapy
|February 11, 2025
概括
这项研究表明,生物类似CT-P17在斑块性牛皮患者中可与EU-adalimumab互换. 在这些阿达利穆马布治疗之间重复切换,证明了生物等价性和类似的安全性.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 皮肤病学 皮肤病学
背景情况:
- 阿达利穆马布是一种适度至严重斑块性牛皮的生物疗法.
- 生物类药物为原始生物制品提供了潜在的替代品.
- 在重复切换场景中评估可互换性对于临床实践至关重要.
研究的目的:
- 评估生物类似物CT-P17和欧盟参考阿达利穆马布 (EU-adalimumab) 的可互换性.
- 在重复开关模型中评估药理动力学 (PK) 等效.
- 为了比较生物类似药和参考产品之间的疗效,安全性和免疫性.
主要方法:
- 随机,双盲,主动控制的3期研究,在成年人的斑块性牛皮.
- 患者接受了EU-adalimumab,然后随机分配到持续的EU-adalimumab或CT-P17和EU-adalimumab之间的重复切换.
- 主要终点:AUCtau,W25-27和Cmax,W25-27;次要终点:PK,疗效,安全性和免疫性.
主要成果:
- 对初级PK终点 (AUCtau,W25-27和Cmax,W25-27) 证明了生物等价性,90%的CI在80-125%的等价率范围内.
- 最小平方平均值的比率为AUCtau,W25-27的99.45%和Cmax,W25-27.5的100.45%
- 连续和切换组之间的有效性,安全性和免疫性是相似的.
结论:
- 该研究满足了其主要的PK终点,证明了CT-P17和EU-adalimumab之间的生物等价性.
- 结果支持CT-P17和EU-adalimumab在中度至重度斑块性牛皮患者中的可互换性.
- CT-P17的安全概况与欧盟的adalimumab相一致.
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