·       在第16周，平均约75%接受Zasocitinib (中译：泽索昔替尼*，下称泽索昔替尼)治疗的头皮银屑病患者，以及约70%接受泽索昔替尼治疗的掌跖部位银屑病患者达到皮损清除或几乎清除。

·       与安慰剂相比，泽索昔替尼在甲银屑病严重程度指数（NAPSI）方面显示出具有统计学意义的改善。

·       结果进一步支持泽索昔替尼有望成为中度至重度斑块状银屑病患者的便捷的每日一次口服治疗选择，帮助患者实现快速、持久且有意义的全身皮损清除，包括最难治部位。

2026年7月16日 - 武田制药（TSE:4502/NYSE:TAK）今日公布了 泽索昔替尼（TAK-279）两项针对中重度斑块状银屑病（PsO）成人患者的关键性3期研究新数据。泽索昔替尼是一种新一代、高度选择性且强效的口服酪氨酸激酶 2（TYK2）抑制剂。¹ 在2026年美国皮肤病学会（AAD）Innovation Academy上公布的这些次要终点数据显示，与安慰剂相比，泽索昔替尼在难治和高影响部位，包括头皮、指/趾甲、手掌和足底显示出一致且高皮损清除率。^1-5

这些数据建立在3期随机、多中心、双盲、安慰剂和活性药物对照的Latitude PsO 3001和3002研究的顶线结果基础之上。在这两项研究中，约70%接受泽索昔替尼治疗的患者在第16周达到静态医师整体评估（sPGA）0/1（皮损清除或几乎清除），且银屑病面积和严重程度指数（PASI）75应答率早在第4周即显著高于安慰剂组，并持续提高至第24周。整体数据表明，即使在最难治的部位，泽索昔替尼也有望实现快速且持久的皮损清除。^2,6

“银屑病是一种复杂的异质性疾病，在不同患者之间以及疾病进程中可表现出不同的临床特征，尤其是在难治的高影响部位。”武田制药高级副总裁、消化及炎性疾病治疗领域负责人Chinwe Ukomadu博士（MD, PhD）表示，“TYK2 在调节驱动疾病的核心免疫通路中发挥关键作用，包括IL-23/IL-17轴和I型干扰素通路，这些通路会导致疾病表现和治疗应答存在差异。我们的3期研究结果进一步支持这款新一代TYK2抑制剂有望通过便捷的每日一次口服方案实现快速、持久且一致的皮损清除。”

3期银屑病研究中高影响部位的结果

3001和3002研究还评估了基线时患有甲银屑病，或至少患有中度头皮或掌跖银屑病的患者。² 研究结果在全身各部位保持一致，包括难治和高影响部位：^2-5

头皮：在第16周，接受泽索昔替尼治疗的头皮银屑病患者中，77%和74%达到头皮特异性医师整体评估（ssPGA）0/1应答；安慰剂组为7%和13%（p<0.001）；阿普米司特（apremilast）组为42%和30%（p<0.001）。²

手掌和足底（掌跖）：在第16周，约70%接受泽索昔替尼治疗的掌跖银屑病患者中达到手和/或足医师整体评估（hfPGA）0/1应答（71%和69%），在数值上高于安慰剂组（22%和10%）及阿普米司特组（44%和43%）。²

甲：与安慰剂相比，泽索昔替尼在第16周甲银屑病严重程度指数（NAPSI）方面也实现了具有统计学意义的改善（p<0.001）。²

·       两项研究中的应答均持续至第24周。²

·       截至第24周，最常见的不良事件为上呼吸道感染、鼻咽炎和痤疮，未发现新的安全性信号。²

“尽管银屑病治疗已取得进展，许多患者仍持续受到症状困扰，尤其是在头皮等高度暴露或敏感部位。头皮银屑病影响约一半的银屑病患者，并可能对日常生活造成更大程度的影响。”肯塔基州路易斯维尔Skin Sciences和Physicians Skin Care创始人兼医学总监、Latitude PsO研究主要研究者及报告作者Leon Kircik博士（MD）表示，“这些研究结果显示，泽索昔替尼在最难治疗的部位也能带来一致的皮损清除效果，包括头皮、甲、手掌和足底，进一步显示出其有望成为重要的口服治疗选择，帮助患者实现有意义的全身皮损清除。”

泽索昔替尼的下一步计划
武田制药计划自本财年起，向美国食品药品监督管理局及其他监管机构提交泽索昔替尼用于治疗斑块状银屑病的新药上市申请。泽索昔替尼也正在开展银屑病关节炎的3期研究，以及克罗恩病、溃疡性结肠炎、白癜风和化脓性汗腺炎（HS）的2期研究。^7-12

审批编号：C-ANPROM/CN/TAK-279/0030

获批日期：2026年7月

声明

1、本资料仅为介绍企业业务及经营活动等情况，并不以宣传任何公司产品和/或服务为目的，更不应被理解为就任何药物、医疗器械及治疗方案的选择提供任何意见或建议。

2、如欲了解任何公司产品、疾病和/或诊疗等相关信息，请务必咨询医疗卫生专业人士。

3、Zasocitinib (中译：泽索昔替尼) （TAK-279）尚未获得国家药品监督管理局的批准，其通用名称亦尚未获得国家药典委员会的批准。*“泽索昔替尼”系公司为便于称谓，参考世界卫生组织国际非专利药品名称（WHO INN）对 Zasocitinib 的中文译名而采用的译名。

参考资料：

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