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与类风湿性关节炎患者的原始 этанерцепт参考配方相比,生物类似剂埃坦塞普特的疗效,安全性和免疫性:一项开放标签,随机,比较,多中心研究

Valentyna Pekhenko¹, Vlad Udovitskiy², Olena Barbukho³

¹Department of General Practice (Family Medicine) at Bogomolets National Medical University, Medical Center "PreventClinic" LLC., Kyiv, Ukraine.

|July 26, 2024

概括

这一III期试验发现,生物类似乙素 (生物乙素) 在类风湿性关节炎患者中与原始乙素 (O-乙素) 治疗上相当. 这两种治疗方法在24周内表现出可比的疗效和安全性.

科学领域:

类风湿病学类风湿病学
免疫学免疫学免疫学
药理学药理学是指药理学的学科.

背景情况:

类风湿性关节炎 (RA) 是一种慢性自身免疫性疾病,其特征是关节炎症.
乙坦塞普特是一种用于管理RA的生物疗法.
生物相似的乙坦塞普特为原始生物提供了潜在的替代品.

研究的目的:

为了确定与原始etanercept (O-etanercept) 相比,生物类似的etanercept (生物etanercept) 的治疗等价性.
评估风湿性关节炎患者的疗效,安全性和免疫性.

主要方法:

第三阶段,随机 1:1 临床试验 (NCT04079374).
156名中度至高RA疾病活性患者接受了生物乙素或O乙素 (25毫克每周两次) 24周.
主要终点:24周ACR20反应率. 二级终点包括安全性和免疫性评估.

主要成果:

生物乙素的ACR20反应率为82.3%,O乙素的ACR20反应率为90.9% (P=0.16),表明没有显著差异.
两组之间没有观察到副作用/事件 (轻度,中度,严重) 的显著差异.
生物乙和O-乙组之间的抗体发育率是可比的,并且在统计学上没有差异.

结论:

生物类似的乙坦塞普特证明了与参考乙坦塞普特配方的治疗等价性.
这些发现支持使用生物类似剂埃坦塞普特作为类风湿性关节炎的可比治疗选择.

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