TURALIO®风险评估和缓解战略计划 (tREMS):3年后期的肝安全评估
Charles Dharmani1, Oluwatosin Fofah1, Maura Fallon2
1Global Epidemiology, Daiichi Sankyo, Inc., Basking Ridge, NJ 07920, USA.
Future oncology (London, England)
|July 18, 2024
概括
在风险管理计划中,Pexidartinib (TURALIO) 治疗在两个月内显示4.7%的肝脏不良事件发生率. 早期监测和干预有效地减轻了潜在的肝损伤风险.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 佩克西达丁尼布 (TURALIO) 是一种向治疗,需要仔细监测安全性.
- 为了确保安全使用,实施了TURALIO风险评估和缓解战略 (tREMS) 计划.
- 评估肝脏安全性至关重要,因为潜在的肝损伤风险与向治疗相关.
研究的目的:
- 评估来自TURALIO风险评估和缓解战略 (tREMS) 计划的肝安全数据.
- 鉴定和表征任何肝脏不良事件或在接受pexidartinib的患者实验室异常.
- 评估风险减轻策略在预防严重肝毒性方面的有效性.
主要方法:
- 在3年的时间里 (2019年8月至2022年6月) 进行了肝病事件的回顾性分析.
- 收集的数据来自tREMS计划中注册和认证的患者.
- 确定并分析了表明肝损伤的肝脏不良事件和实验室异常.
主要成果:
- 共有451名患者参加了tREMS计划.
- 21名患者 (4.7%) 经历了肝脏不良事件或实验室异常.
- 所有确定的肝病事件都发生在启动pexidartinib治疗后的两个月内,没有发现新的安全信号.
结论:
- 在tREMS计划中观察到的肝安全性概况与之前的临床试验数据 (例如ENLIVEN试验) 一致.
- 在接受pexidartinib治疗的患者中,主动监测肝酶是必不可少的.
- 早期干预,包括剂量调整和停止治疗,有效地减轻了pexidartinib诱导的肝毒性风险.
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