在中度至重度慢性斑块性牛皮患者中CT-P17阿达利穆马布生物相似剂:第三阶段可互换性研究的开放式扩展
David M Pariser1, Mark G Lebwohl2, Janusz Jaworski3
1Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, USA.
Dermatology and therapy
|March 28, 2025
概括
这项研究证实,阿达利穆马布生物类似剂CT-P17与参考阿达利穆马布可互换. 长期数据显示了一致的疗效,安全性和免疫性,支持其在牛皮治疗中的使用.
科学领域:
- 免疫学 免疫学 免疫学
- 皮肤病学 皮肤病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 之前的第三阶段研究表明,在27周时,阿达利穆马布生物类似物CT-P17和参考阿达利穆马布的可互换性.
- 此分析报告了从开放标签延长期 (OLE) 到52周的二次数据.
研究的目的:
- 在OLE期间评估CT-P17的长期疗效,安全性,药理动力学和免疫性.
- 评估继续治疗或切换对中度至重慢性斑块性牛皮患者结局的影响.
主要方法:
- 在患有牛皮的成年人中进行随机,双盲,主动控制的第三期研究.
- 患者接受了参考阿达利穆马布,然后随机分配到持续治疗或在参考阿达利穆马布和CT-P17之间切换.
- 一个开放的扩展包括从第27周到第49周接受CT-P17 EOW的所有患者.
主要成果:
- 在整个OLE期间,效率的提高一直保持,在连续和切换组之间是可比的.
- 总体而言,52周PASI得分从基线改善的平均值为90.34%.
- 安全性概况和免疫性保持一致,在OLE期间免疫性没有增加.
结论:
- 在整个OLE中,CT-P17的药理动力学,疗效,安全性和免疫性保持一致.
- 结果是可比的,无论之前的治疗或切换历史.
- 亚达利穆马布生物类似剂CT-P17显示了持续的治疗效益和有利的安全性.
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