通过暴露-反应建模,优化中度至重度斑块性牛皮患者sequukinumab剂量方案
Yixiao Liu1, Ling Xu1, Xinrui Wang1
1Center for Drug Clinical Research, Institute of Interdisciplinary Integrative Medicine Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Expert review of clinical pharmacology
|September 14, 2023
概括
优化secukinumab对斑块性牛皮的剂量至关重要. 这项研究开发了一种暴露-反应模型,根据患者的体重来定制维持剂量,以提高疗效.
科学领域:
- 皮肤病学 皮肤病学
- 制药指标 (Pharmacometrics) 是一个指标.
- 临床药理学 临床药理学
背景情况:
- 中度至重度的斑块性牛皮需要优化secukinumab的剂量.
- 目前批准的治疗方案可能对所有患者都不有效.
研究的目的:
- 为secukinumab开发一个暴露-反应模型.
- 根据患者的体重,建议量身定制的secukinumab剂量方案.
主要方法:
- 随机对照试验的基于模型的元分析.
- 包括16项试验,涉及6,197名受试者.
- 分析了52周的PASI 75和PASI 90应答率.
主要成果:
- 模型准确地描述了PASI 75和PASI 90随时间推移的反应.
- 建议在体重为50-60公斤的患者服用较低剂量 (150毫克每4至3周) .
- 对于体重为120公斤的患者,建议使用更高的剂量 (300毫克每3周一次).
- 体重70-110公斤的患者维持了批准的剂量 (300毫克每4周).
结论:
- 暴露-反应模型可以指导secokinumab的剂量.
- 基于体重的剂量建议提高了疗效和经济性.
- 优化的治疗方案可以改善斑块性牛皮的治疗.
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