德乌克拉维西提尼:在第3期斑块牛皮试验中感兴趣的不良事件
Joseph F Merola1, Laura K Ferris2, Jeffrey M Sobell3
1Department of Dermatology, Medicine and Rheumatology, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390, USA. Joseph.Merola@UTSouthwestern.edu.
Dermatology and therapy
|February 7, 2025
概括
对斑块性牛皮治疗deucravacitinib的治疗显示,在三年内不良事件发生率稳定或下降. 安全性概况与其他抗皮病疗法相比仍然相当.
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:
- 德乌克拉维西提尼布是一种口服,选择性,全性氨酸激酶2抑制剂,已批准用于中度至重度的斑块性牛皮.
- 它在牛皮的安全性和有效性已经在3年的3期试验 (POETYK PSO-1,PSO-2和LTE) 中确立.
研究的目的:
- 通过在3年内分析感兴趣的不良事件 (AEI),评估deucravacitinib的长期安全性.
- 为了评估AEI的累积暴露调整发病率 (EAIRs) 在斑块性牛皮的患者中.
主要方法:
- 来自POETYK PSO-1,PSO-2和长期扩展试验的第三阶段AEI的分析.
- 计算累计曝光调整的发病率 (EAIRs) 对3年的各种不良事件的计算.
主要成果:
- 严重感染的三年EAIR为2.5/100人年 (PY),包括COVID-19 (1.6/100 PY) 和疹 (0.6/100 PY).
- 除了COVID-19外,严重感染人数为0.9/100 PY. 主要不良心血管事件 (MACE) 和静脉血栓栓塞率分别为0.3/100 PY和0.1/100 PY.
- 恶性病的EAIR总体为0.9/100 PY (0.5/100 PY不包括NMSC). 观察到皮肤事件,如 (1.3/100 PY) 和毛囊炎 (1.1/100 PY). 在3年内,利率保持稳定或下降.
结论:
- 在斑块性牛皮患者治疗deucravacitinib的患者在3年内表现出稳定或下降的不良事件累积发病率.
- 观察到的AEI率与其他抗 psoriatic疗法相似,支持其长期安全性.
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