拟议的丹诺苏马布生物类似物SB16与参考丹诺苏马布在绝经后骨质疏松症:第3期结果至12个月
Bente Langdahl1, Yoon-Sok Chung2,3, Rafal Plebanski4
1Department of Endocrinology, Aarhus University Hospital and Department of Clinical Medicine, Aarhus University, Aarhus, 8200, Denmark.
The Journal of clinical endocrinology and metabolism
|September 7, 2024
概括
在绝经后的骨质疏松症患者中,SB16与登诺苏马布表现出生物相似性. 疗效,安全性和免疫性是可比的,支持SB16作为denosumab的生物类似物.
科学领域:
- 风湿病学和内分泌学.
- 药理学和制药科学 药理学和制药科学
背景情况:
- SB16是denosumab (品牌名称:Prolia) 的一个拟议的生物类似药.
- 德诺苏马布是绝经后骨质疏松症的关键治疗方法.
研究的目的:
- 为了评估SB16与绝经后骨质疏松症妇女的denosumab的生物相似性.
- 评估疗效,药理动力学,药理动力学,安全性和免疫性.
主要方法:
- 第三阶段,随机,双盲,多中心研究.
- 457名绝经后骨质疏松症患者被随机分为SB16或denosumab.
- 治疗在0个月和6个月进行皮下注射;报告了12个月的结果.
主要成果:
- 主要终点:第12个月腰椎骨矿物质密度 (BMD) 的百分比变化显示了SB16和denosumab (0.33%的差异) 之间的等价性.
- 二级终点,包括部和大腿部骨质量,是可比的.
- 药理动力学,药理动力学,安全性和免疫性概况在各组之间也相似.
结论:
- 这项研究支持SB16与denosumab的生物相似性.
- 观察到可比的疗效,安全性和免疫性概况.
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