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在多发性硬化症药物开发中,哪些实验因素决定了动物向人类的成功转换? 一个系统的审查和元分析

Ingrid Berg¹, Pia Härvelid¹, Wolfgang Emanuel Zürrer¹

¹Center for Reproducible Science, University of Zurich, Zurich, Switzerland; Clinical Neuroscience Center, University of Zurich, Zurich, Switzerland.

|November 8, 2024

概括

对多发性硬化症 (MS) 药物的动物研究在预测人类结果方面取得了有限的成功. 研究必须改进实验方法和临床前临床调整,以改善药物开发.

科学领域:

神经科学是一个神经科学.
药理学药理学是指药理学的学科.
翻译医学是一种翻译医学.

背景情况:

多发性硬化症 (MS) 药物开发取得了成功,但动物研究对人类翻译的预测价值仍然不清楚.
评估成功的MS药物转换的动物研究预测因素对于改善临床试验结果至关重要.

研究的目的:

系统地比较已批准的MS疾病修饰疗法 (DMT) 的动物研究与在临床试验中失败的动物研究.
确定MS疗法成功从动物转化到人类的预测因素.

主要方法:

使用元分析对MS DMTs的497项动物研究进行了系统审查.
经批准的DMT与未经批准的DMT的结局效应大小进行比较.
评估效果大小和各种实验条件作为翻译成功的预测指标.

主要成果:

动物研究结果或各种测试条件与成功批准药物之间没有发现任何关联.
大多数研究 (86%) 使用实验性自身免疫脑膜炎 (EAE) 在小鼠 (80%),主要是女性 (76%).
大多数研究是在临床试验或监管部门批准后发表的.

结论:

将药物从动物模型转化为MS的临床实践是复杂的.
有限的实验方法和临床前和临床研究之间的断开带来了挑战.
建议简化多发性硬化症药物开发,提高动物研究对患者的相关性.

关键词:

药物开发药物开发实验性自身免疫性脑膜炎进行元分析分析.多发性硬化症是多发性硬化症.系统性审查系统性审查翻译翻译翻译翻译

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