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在患有青少年异常性关节炎的患者中使用巴里西提尼布全米缩放的种群药动力学模型
Rodney L Decker1, C Steven Ernest2, David B Radtke1
1Eli Lilly and Company, Indianapolis, Indiana, USA.
在患有青少年异常性关节炎 (JIA) 的儿科患者中,使用人口药动力学建模确定了巴里西提尼布的新的基于体重的剂量方案. 这确保了JIA儿童对巴里西提尼布的适当暴露.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科风湿病学 儿科风湿病学
背景情况:
- 巴里西丁尼布已被批准用于类风湿性关节炎 (RA) 和青少年异常性关节炎 (JIA).
- 优化儿科剂量对于有效和安全的JIA治疗至关重要.
研究的目的:
- 在患有JIA的儿科患者中描述巴里西提尼布的群体药理动力学 (PK).
- 为儿童JIA患者建立巴里西提尼布的基于体重的剂量方案.
主要方法:
- 一项3期试验 (JUVE-BASIS) 招募了患有多关节性JIA的儿科患者 (2至<18岁).
- 用217名儿科患者的巴里西提尼布度数据开发了人群PK模型.
- 全尺度缩放和功能 (GFR) 被纳入了PK模型.
主要成果:
- 在儿科JIA患者中巴里西提尼布的PK被描述为具有全米缩放的2个隔间模型.
- 推基于体重的剂量:2mg QD 10至<30公斤,4mg QD ≥30公斤.
- 该模型成功预测了与成人4毫克QD水平相匹配的暴露量.
结论:
- 具有全米缩放的人口PK建模对于确定儿科剂量是有效的.
- 确定的基于体重的疗法为儿科JIA患者提供了适当的巴里西提尼布暴露.
- 这种方法支持优化JIA儿童的巴里西提尼布治疗.
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