行业动态|诺华首次发布，可善挺®在银屑病关节炎所有关键表现中发挥疗效

来源：药学进展

此次公布的数据首次显示出生物制剂在治疗银屑病关节炎（PsA）中轴表现方面的疗效和安全性。目前该疾病症影响着全世界约3500万名患者1。

在第12周，有66.3%接受司库奇尤单抗150 mg治疗的患者其“中轴型银屑病关节炎”的体征和症状取得了迅速、显著的改善。

可善挺®首次兼顾了银屑病、银屑病关节炎和中轴关节表现的治疗。

研究结果进一步证实了可善挺®可以快速、综合治疗脊柱关节炎和银屑病相关疾病，迄今已惠及全球逾20万患者。

2019年6月12日，巴塞尔 —今日，诺华公布了MAXIMISE 研究的最新数据。该研究旨在评估可善挺®在治疗银屑病关节炎（PsA）中轴表现方面的有效性和安全性。

这项持续进行中的、为期52周的IIIb期研究已达到其主要终点和关键次要终点，分别有63.1%接受可善挺®300 mg治疗和66.3%接受可善挺®150 mg治疗的患者在第12周时达到ASAS20（安慰剂组为31.3%）。起效迅速，症状缓解早在第4周便已显现。且试验证明该药物具有良好安全性，与之前的临床试验结果一致2。

 “多达三分之二的银屑病关节炎患者会经历炎症性背痛，活动能力受到限制，”NIHR临床科学家兼英国牛津大学纳菲尔德骨科、风湿病学和肌肉骨骼科学研究所高级临床研究员Laura Coates博士表示，“此次研究可以为临床医生提供证据，帮助他们选择一种银屑病关节炎综合疗法，以解决不同的患者表型。”

银屑病关节炎是一种复杂疾病，多种表现导致患者出现不同症状3,4。据估计，全世界约有多达5000万人正受此疾病困扰5-8。银屑病关节炎是累及关节的长期炎症性疾病家族（脊柱关节炎）中的一种，与银屑病密切相关；多达40%的银屑病患者同时患有银屑病关节炎6。

 “这是我们第一次见到生物制剂在第12周时对银屑病关节炎中轴表现显示出疗效，”西班牙圣地亚哥-德孔波斯代拉大学临床医院风湿科主任Antonio Mera Varela博士表示 ，“作为一名医生，有药物能帮助患者全方位控制银屑病关节炎，包括脊柱炎症、关节炎症、附着点炎、指趾炎以及皮肤和甲银屑病，这对我来说非常重要。”

关于可善挺®（司库奇尤单抗）

可善挺®是目前首个也是唯一一个可直接抑制白介素-17A (IL-17A) 的全人源化生物制剂。白介素-17A是参与银屑病关节炎（PsA）、银屑病（PsO）和强直性脊柱炎（AS）炎症产生及疾病进展的核心致病因子，在发病机制中起基石作用12 。

可善挺®拥有强大的临床证据支持，其中包括针对头皮、手掌、脚跟和指甲等银屑病顽固表现以及PsA和AS的专门研究13-15。可善挺®在治疗银屑病相关疾病方面显示出持久的疗效和良好的安全性，从而提供了综合治疗方案13。该疗法在3项针对PsO、PsA和AS进行的五年III期扩展研究中12-16表现出持续安全性和长期疗效。自上市以来，可善挺®已惠及全球超过20万名患者17。

免责声明

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参考资料

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[12] Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici... [Last accessed: May 2019].

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[17] Novartis, data on file. May 2019