在糖尿病斑点中使用Aflibercept生物类似药MYL-1701P与参考Aflibercept:INSIGHT随机临床试验
Susan B Bressler1, Abhijit Barve2, Prasanna C Ganapathi3
1Wilmer Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
JAMA ophthalmology
|September 12, 2024
概括
作为aflibercept生物类似剂的MYL-1701P,在治疗糖尿病黄斑 (DME) 时,其疗效和安全性与参考aflibercept相当. 这表明MYL-1701P对于患有DME的患者来说是一个可行的替代品.
科学领域:
- 眼科医生 眼科 眼科
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 糖尿病黄斑 (DME) 是糖尿病患者视力丧失的主要原因.
- 生物仿制药提供了潜在的成本节约,并扩大了对生物治疗的获取.
- 阿弗利伯塞普特是对DME的标准治疗方法,但生物类似药的选择尚未在这个适应症中得到广泛研究.
研究的目的:
- 为了评估MYL-1701P的疗效和安全性,一个aflibercept生物类似剂,与DME患者的参考aflibercept相比.
- 为了确定MYL-1701P是否符合预定义的视力敏度和解剖学变化等效率.
主要方法:
- 一个双面罩的随机临床试验,涉及全球77个中心的355名参与者.
- 参与者接受了MYL-1701P或参考aflibercept通过静脉内注射,持续52周.
- 主要结局是第8周最佳校正视敏度 (BCVA) 的变化;次要结局包括中央子场厚度 (CST),安全性和免疫性.
主要成果:
- 在第8周,MYL-1701P的BCVA平均变化为6.60个字母,而aflibercept的6.56个字母,达到主要疗效终点 (调整后差异为0.04个字母).
- 这两种治疗都导致了可比的CST减少和类似的眼部和非眼部不良事件发生率.
- 通过抗药抗体 (ADA) 评估的免疫性在两组之间也是可比的.
结论:
- 在治疗DME的有效性方面,MYL-1701P在临床上相当于参考aflibercept.
- MYL-1701P的安全性和免疫性概况与参考aflibercept相似.
- 这些发现支持使用MYL-1701P作为DME管理的成本有效替代品.
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