ARD:选择性TYK2抑制剂德卡伐替尼在银屑病关节炎II期试验中的疗效和安全性

2022-06-29 MedSci原创 MedSci原创

使用选择性口服选择性酪氨酸激酶2 (TYK2)抑制剂德卡伐替尼治疗具有良好的耐受性,在活动性银屑病关节炎(PsA)患者的 ACR-20、多重控制的次要终点和其他探索性疗效测量方面比安慰剂有更大的改善。

目的评估口服选择性酪氨酸激酶2 (TYK2)抑制剂德卡伐替尼在活动性银屑病关节炎(PsA)患者中的疗效和安全性。

方法在这项双盲II期试验中,203PsA患者以1:1:1的比例随机分配至安慰剂组、德卡伐替尼6 mg每天一次或12 mg每天一次组。主要终点是在第16周时美国风湿病学会20 (ACR-20)的反应,还评估次要终点和其他探索性终点指标。

结果在第16周,与安慰剂(31.8%)相比,德卡伐替尼6 mg每天一次 (52.9%, p=0.0134) 12 mg每天一次(62.7%, p=0.0004)ACR-20反应显著更高。两种德卡伐替尼剂量均在健康评估问卷-残疾指数、36物理成分总结评分简表以及银屑病面积和严重性指数-75反应的多重控制次要终点方面,与安慰剂相比有显著改善(p0.05)。德卡伐替尼治疗的多个探索性终点也有所改善。 德卡伐替尼治疗的患者最常见的不良事件(AE)(5%)是鼻咽炎、上呼吸道感染、鼻窦炎、支气管炎、皮疹、头痛和腹泻。没有严重的AE,也没有发生带状疱疹、机会性感染和主要不良心血管事件,德卡伐替尼治疗的实验室参数与安慰剂相比平均变化方面也不存在差异。

结论使用选择性TYK2抑制剂德卡伐替尼治疗具有良好的耐受性,并且在PsA患者的 ACR-20、多重控制的次要终点和其他探索性疗效测量方面比安慰剂有更大的改善。有必要在较长时间内使用德卡伐替尼进行更大规模的试验,以确认其在PsA中的安全性和益处。

出处:Mease PJ, Deodhar AA, van der Heijde D, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Annals of the Rheumatic Diseases 2022;81:815-822.

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    2022-09-21 liuquan
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    2023-05-05 jklm09
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    2022-06-29 lmm397

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