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在活性牛皮关节炎中对托法西提尼布的暴露-反应分析:来自两个第三阶段研究的结果

Sujatha Menon¹, Satoshi Shoji², Shinichi Tsuchiwata²

¹Pfizer Inc., Groton, CT, USA.

Journal of clinical pharmacology

|October 25, 2024

概括

托法西替尼有效治疗牛皮性关节炎 (PsA) 通过证明一个明确的暴露-反应关系美国风湿病学会 (ACR) 标准. 血红蛋白变化是最小的,支持托法西提尼布.

科学领域:

类风湿病学类风湿病学
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

牛皮关节炎 (PsA) 是一种慢性炎症性疾病.
托法西提尼布是一种口服的Janus激酶抑制剂,用于PSA治疗.

研究的目的:

在PSA患者中分析托法西替尼与疗效 (ACR标准) 之间的暴露-反应 (E-R) 关系.
为了评估托法西提尼布暴露和血红蛋白 (Hgb) 变化在PsA患者之间的关系.

主要方法:

从两个第三阶段研究 (NCT01877668,NCT01882439) 的数据汇总后期分析.
使用四类顺序的分类E-R模型用于ACR响应,以及用于Hgb变化的间接响应模型.
基于美国风湿病学学院 (ACR) 响应标准 (ACR20,ACR50,ACR70) 在第3个月的模拟疗效.

主要成果:

一个最大药物效应 (Emax) 模型描述了托法西提尼布暴露与ACR反应的关系.
预测的ACR20反应率为51% (5 mg两次) 和58% (10 mg两次);ACR50为29%和36%;ACR70为15%和20%.
间接反应模型很好地预测了Hgb度-时间概况;Hgb>2 g/dL的下降在tofacitinib 5 mg两次和安慰剂之间是相似的.

结论:

托法西提尼布表现出剂量依赖的E-R关系,用于PSA的疗效.
血红蛋白变化的安全性表现与安慰剂相一致,每天两次服用5毫克剂量.
结果支持每天两次使用5毫克托法西提尼布治疗活跃的PSA.

关键词:

有效性有效性有效性.暴露响应反应血红蛋白血红蛋白是一个牛皮关节炎牛皮关节炎托法西提尼布 (tofacitinib) 是一种

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