优化从升级静脉注射到皮下注射的Infliximab转换:一个人群的药理动力学研究
Zhigang Wang1, Marc Ferrante2,3, Séverine Vermeire2,3
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Journal of Crohn's & colitis
|August 28, 2025
概括
从静脉注射转换为皮下注射的患者可以保持治疗效果. 这项研究表明,在克罗恩病和性结肠炎患者中,切换为皮下注射的Infliximab是安全有效的.
科学领域:
- 胃肠病学
- 药理学
- 临床治疗方法
背景情况:
- 对于从升级型静脉注射 (IV) 转换为标准型皮下注射 (SC) 的CT- P13 (120毫克两周一次) 疗效存在不确定性.
- 本研究涉及克罗恩病 (CD) 和性结肠炎 (UC) 患者在IV-SC转换期间的剂量-暴露-反应关系.
研究的目的:
- 在从静脉注射到静脉下注射的过程中,研究因弗利克西马布的剂量-暴露-反应关系.
- 评估在CD和UC患者中切换治疗响应标志物的影响.
主要方法:
- 使用健康志愿者和CD和UC患者的I期研究数据进行了群体的药理动力学建模和模拟.
- 在从静脉输入到静脉输入因弗利西马布的转换过程中,测量了便中的calprotectin (FC),CD中的内镜缓解 (ER),UC中的内镜改善 (EI).
- 模拟包括1000名虚拟患者,以评估转换后的FC水平和ER/EI概率.
主要成果:
- 降低FC水平与整体暴露增加相关.
- 在第14周降低FC预测UC中EI的概率增加,但在CD中并非ER.
- 模拟表明,在第6周转换为SC因弗利西马布改善了FC并增加了EI的概率.
- 在升级 IV 维持疗程 (高达 10 mg/ kg Q6W/ Q8W) 的虚拟患者可以转换为 120 mg Q2W SC 输血剂,而不会增加 FC.
- 研发了一种临床软件工具,用于指导输入因弗利克西马布的转换.
结论:
- 接受 Q6W 和 Q8W IV 疗程的患者可以转换为标准的 SC 疗程,而不会出现 FC 的增加.
- 这项研究提供了一个指导临床决策的模型,以确保维持治疗效果.
相关概念视频
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