阿达利穆马布生物类似药的有效性和牛皮的原始剂
Duc Binh Phan1, Anthony P Bewley2, Philip Laws3
1Dermatology Centre, Northern Care Alliance NHS Foundation Trust, National Institute for Health and Care Research, Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom.
JAMA dermatology
|March 5, 2025
概括
阿达利穆马布生物类似剂Amjevita和Imraldi在新使用者和从Humira转换者中,在治疗牛皮方面表现出与Humira相似的有效性. 这一发现支持这些生物类似药的采用增加.
科学领域:
- 皮肤病学 皮肤病学
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
背景情况:
- 治疗牛皮的阿达利穆马布生物类似药在现实世界中的有效性仍然不确定,这阻碍了其广泛采用.
- 阿达利穆马布是适度至重症牛皮的关键生物疗法.
研究的目的:
- 在患有牛皮的患者中,比较阿达利穆马布生物类似药Amjevita和Imraldi与原始阿达利穆马布 (Humira) 的实际有效性.
- 为了评估新用户开始阿达利穆马布治疗和从Humira转换为生物类似药的患者的有效性.
主要方法:
- 模拟了2项实用临床试验,使用来自英国皮肤病学家协会生物和免疫调节剂注册表 (BADBIR) 的数据.
- 包括先前没有服用阿达利木马布的患者开始使用Amjevita或Imraldi而不是Humira,以及从Humira转换为Amjevita或Imraldi而不是继续使用Humira的患者.
- 有效性是通过皮病区域和严重性指数 (PASI) 12个月≤2和≤4的得分来衡量,使用逆倾向治疗权重和后勤回归来分析.
主要成果:
- 与Humira相比,在Amjevita或Imraldi的新用户中没有观察到12个月后实现PASI ≤2或PASI ≤4的显著差异.
- 与继续服用Humira的患者相比,切换为Amjevita或Imraldi的患者在实现PASI ≤2或PASI ≤4方面也没有统计学上显著的差异.
- 这项研究包括11,400名患者,其中6,133人在新用户分析中,5,267人在交换器分析中.
结论:
- 在真实世界治疗牛皮的环境中,Adalimumab生物类似药Amjevita和Imraldi与Humira一样有效.
- 这些发现支持使用Amjevita和Imraldi用于启动治疗和从原始治疗者Adalimumab切换.
- 这种可比的有效性可以帮助解决不确定性,并促进更广泛地采用阿达利姆巴生物类似药.
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