在中度至重的斑块性牛皮症中SYSA1902的有效性和安全性与参考ustekinumab相比:一个多中心的,随机的,III期研究
Lixin Xia1, Guoying Miao2, Xiumin Yang3
1Department of Dermatology, The First Hospital of China Medical University, Shenyang, China.
Journal of the American Academy of Dermatology
|April 10, 2025
概括
SYSA1902在治疗中度至重度的斑块性牛皮时,证明了与乌斯特基努马布相当的疗效和安全性. 这种生物仿制药为患有这种慢性皮肤疾病的患者提供了可比的治疗选择.
科学领域:
- 皮肤病学 皮肤病学
- 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:
- SYSA1902是一种新开发的生物类似药,参考 ustekinumab.
- 乌斯特基努马布是治疗中度至重度斑块性牛皮的已知生物疗法.
研究的目的:
- 为了评估SYSA1902的疗效和安全性,与参考乌斯特基努马布相比.
- 在斑块性牛皮患者中确定SYSA1902和ustekinumab之间的治疗等价性.
主要方法:
- 一项随机对照试验,涉及446名中度至重度斑块性牛皮的患者.
- 患者按照定义的剂量计划接受SYSA1902或乌斯特基努马布 (45毫克皮下注射).
- 主要疗效终点是第12周牛皮区域和严重性指数 (PASI) 的百分比改善.
主要成果:
- 在第12周,SYSA1902的平均PASI改善率为86.4%,而乌斯特基努马布的平均改善率为84.7% (差异1.68%,95% CI:-1.45至4.81).
- 12周的PASI 75应答率为SYSA1902的83.3%和乌斯特基努马布的79.3%.
- 治疗出现的不良事件发生率相似 (SYSA1902的89.3%,乌斯特基努马布的85.6%),症状轻度至中度.
结论:
- 在治疗中度至重度的斑块性牛皮时,SYSA1902在治疗上相当于乌斯特基努马布.
- 这项研究仅限于中国患者,这表明在不同人群中进一步研究可能是有益的.
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