贝纳利祖马布在患有严重酸性喘的儿童中:药理动力学和长期安全性 (TATE研究)
H James Wedner1, Takao Fujisawa2, Theresa W Guilbert3,4
1Division of Allergy and Immunology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
概括
在患有严重酸性喘的儿童中,本拉利祖马布治疗显示出有利的药理动力学,药理动力学和安全性. 这些发现支持其在年轻患者中的使用,类似于青少年和成年人.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 儿科喘管理 儿科喘管理
- 免疫学 免疫学 免疫学
背景情况:
- 贝纳利祖马布是经批准的用于治疗严重失控喘的补充治疗.
- 之前的研究集中在12岁及以上的患者身上.
- 在TATE研究中,对儿童的本拉利祖马布进行了研究.
研究的目的:
- 评估本拉利祖马布在儿童中的药理动力学 (PK),药理动力学 (PD) 和安全性.
- 为了评估本拉利祖马布在儿童群体中严重的酸性喘中的疗效.
主要方法:
- 在6至11岁的儿童 (以及来自日本的12至14岁) 中进行了开放式的第三期研究 (TATE).
- 贝纳利祖马布以10/30毫克的剂量根据体重 (<35/≥35公斤) 给予.
- 主要终点包括Cmax,清除率,t1/2和血中乙氨基酸细胞计数;安全性和耐受性被评估.
主要成果:
- 在所有剂量/体重组中观察到近乎完全的血中乙氨基细胞枯竭.
- 药物动力学参数 (清除率,t1/2) 与预期的个人资料一致.
- 探索性分析表明,肺功能和喘控制的数值改善.
结论:
- 药理动力学,药理动力学和安全性数据支持本拉利祖马布在患有严重酸性喘的儿童中长期使用.
- 这些发现与青少年和成年人群中的发现相似.
- 贝纳利祖马布在儿科重症酸性喘治疗中表现出有利的特征.
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