智通财经APP获悉,6月12日,百时美施贵宝(BMY.US)公布了POETYK PsA-1(IM011-054)这一关键3期试验的积极结果。该试验旨在评估氘可来昔替尼在治疗既往未接受过生物制剂类改善病情抗风湿药物(bDMARD)的活动性银屑病关节炎成人患者中的疗效和安全性。试验达到了主要终点,即治疗16周时,氘可来昔替尼治疗组患者的ACR20(疾病体征和症状至少改善20%)应答比例显著高于安慰剂组(分别为:54.2% vs. 34.1%)。
16周治疗期间,氘可来昔替尼的安全性特征与其此前的临床试验项目中观察到的结果一致,包括3期POETYK PsA-2试验以及针对中重度斑块状银屑病的3期临床试验。氘可来昔替尼是一种具有独特作用机制的口服、选择性酪氨酸激酶2(TYK2)抑制剂,也是一类新型小分子药物代表,正在进行多种免疫介导疾病临床试验。
百时美施贵宝的科学家们设计氘可来昔替尼来选择性地靶向TYK2,从而抑制IL-23、IL-12和 I型干扰素(IFN)的信号传导,而这些细胞因子都是参与多种免疫介导疾病发病机制的关键细胞因子。氘可来昔替尼通过与TYK2的调节结构域结合实现高度选择性,促成对TYK2及其下游功能的变构抑制。在生理浓度范围内,氘可来昔替尼可选择性地抑制 TYK2。在治疗剂量下,氘可来昔替尼不会抑制JAK1、JAK2或JAK3。氘可来昔替尼已在全球多个国家和地区获批,用于治疗成年中重度斑块状银屑病患者。
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