基于模型的替代剂量策略用于皮下尼沃卢马布,以提高成本效益
Yang Wang1, Laura H Bukkems1, Rob Ter Heine2
1Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
新的皮下尼沃卢马布剂量方案降低了成本和患者负担. 基于体重的间隔和延长的剂量间隔显著降低了年度费用,同时保持了药物暴露.
科学领域:
- 药理学和瘤学 药理学和瘤学
- 药物开发和药物管理
背景情况:
- 皮下尼沃卢马布 (SC nivolumab) 的使用带来了财务,环境和能力方面的挑战.
- 当前的固定的SC剂量显示出比历史的静脉注射剂量更高的暴露和变化.
研究的目的:
- 为了开发替代的SC尼沃卢马布剂量方案.
- 旨在降低药品费用和患者治疗负担.
- 通过新的治疗方案,确保有效的药物暴露.
主要方法:
- 使用的人口药理动力学模拟.
- 通过药理动力学模型探索了替代的SC疗法.
- 患者按体重分层 (<60公斤,60-90公斤,90公斤以上).
- 开发了两种实验性渐进方案:SC配方的度驱动和IV输液.
主要成果:
- 基于体重的治疗方案 (1200毫克每5-7周) 每年节省35%.
- 延长间隔治疗方案 (每10周1200毫克) 每年节省60%,保持2.5毫克/升的最低度.
- 每7周一次输液注入SC配方,每年节省43%.
结论:
- 取决于体重的间隔剂量是具有成本效益的,患者友好的,并优化了SCnivolumab的使用.
- 拟议方案支持临床非劣势性研究,比较标准剂量的替代方案.
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