局部托法西提尼布治疗无氧性皮肤炎 - 随机第三期临床试验的结果:首次批准
Alok R Chaturvedi1, Hemant G Zaveri1, Dhaval V Patel1
1From the Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India.
Indian journal of dermatology
|January 26, 2026
概括
托法西提尼布膏 (Tof-O) 在治疗轻度至中度的亚托皮性皮肤炎 (AD) 方面显示出与皮梅克罗利木斯奶油相当的疗效. 这项研究发现,Tof-O在使用四周后对AD患者安全有效.
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:
- 简氏激酶 (JAK) 抑制剂越来越多地被批准用于亚托皮炎 (AD) 治疗.
- 美国FDA批准了Ruxolitinib,Abrocitinib和Upadacitinib用于AD.
- 一种新的局部托法西提尼布配方被开发用于轻度至中度的AD.
研究的目的:
- 为了评估局部托法西提尼布药膏 (Tof-O) 与皮梅克罗利慕斯奶油 (Pim-C) 的疗效和安全性.
- 评估Tof-O在患有轻度至中度亚托皮性皮肤炎的成年患者中.
主要方法:
- 一个前性的,开放的,多中心的第三阶段临床试验.
- 184名患有轻度至中度AD的成年患者被随机分配给Tof-O或Pim-C治疗4周.
- 有效性指标包括湿疹区域和严重性指数 (EASI),调查人员全球评估 (vIGA-AD),身体表面积 (BSA) 和.
主要成果:
- 托法西提尼布膏显著改善了EASI得分,与Pimecrolimus奶油相比.
- 这两组在EASI 50,75,90,vIGA-AD,BSA和方面都有显著改善.
- 在两组中都没有观察到实验室值或安全参数的显著变化.
结论:
- 局部托法西提尼布膏在轻度至中度的AD中表现出良好的安全性和有效性.
- 在4周后,治疗显示了关键疗效终点的显著改善.
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