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在患有GH缺乏症的儿科患者每周索马特龙治疗期间IGF-1评估

Satyaprakash Nayak¹, Michael P Wajnrajch^2,3, Joan Korth-Bradley⁴

¹Pfizer Inc, Cambridge, MA 02139, USA.

Journal of the Endocrine Society

|January 28, 2025

概括

现在,医生可以预测胰岛素样生长因子1 (IGF-1) 的平均水平,在儿童生长激素缺乏症 (GHD) 患者接受索马特龙治疗. 这种方法在每周剂量间隔的任何时间使用一次IGF-1测量,以更好地监测治疗.

科学领域:

内分泌学在内分泌学.
药理动力学药理动力学
儿童生长障碍儿童生长障碍

背景情况:

胰岛素类生长因子1 (IGF-1) 监测对于评估GH缺乏症患者GH治疗的安全性和有效性至关重要.
索马特罗贡是一种长期作用的GH疗法,用于儿科GHD,需要仔细评估IGF-1水平.
剂后96小时测量的IGF-1水平最好代表平均索马特龙暴露.

研究的目的:

开发一种简单的方法,用于预测 somatrogon 管理后 IGF-1 度的平均值.
为了使预测使用一个IGF-1测量,在7天的剂量间隔内在任何时间进行测量.

主要方法:

利用了2期和3期索马特龙研究的数据.
开发了一种具有延迟第一阶吸收的2个分部药理动力学模型.
应用了一个间接反应的药理动力学/药理动力学模型和模拟来预测IGF-1和IGF-1标准偏差得分 (SDS).

主要成果:

模拟涉及来自151名参与者的16213份剂量记录.
预测的IGF-1和IGF-1SDS值与96小时后的剂量测量进行了缩放.
创建了一个表格,以指导根据测量时间预测平均IGF-1和IGF-1SDS的调整.

结论:

已经开发了一种简化的方法来预测平均每周IGF-1值.
这种方法允许使用在剂量间隔期间在任何时间进行的IGF-1测量进行准确的预测.

关键词:

在IGF-1的基础上,IGF-1 生物标志物生物标志物生长激素缺乏,生长激素缺乏.长效生长激素长效生长激素的作用药理动力学是药理动力学的一个方面.索马特罗贡 (somatrogon) 是一种体内生长的物质.

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