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
- 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。”
此次研究数据是现有各项证据的又一有力补充,充分证明可善挺®能同时治疗多种银屑病相关疾病表现。数据将于6月12-15日在西班牙马德里举行的欧洲风湿病年会(EULAR)上公布。
* 银屑病关节炎、强直性脊柱炎适应症尚未在中国大陆获批
关于MAXIMISE研究
MAXIMISE是一项为期52周的双盲、随机、安慰剂对照的IIIb期研究,旨在评估可善挺®在治疗银屑病关节炎中轴表现方面的有效性和安全性。MAXIMISE共纳入498例银屑病关节炎患者,其临床诊断已累及中轴关节,其脊柱疼痛按视觉模拟评分法(VAS)>40/100,且在应用至少两种非甾体抗炎药后仍显示BASDAI >4。患者每周接受1次可善挺®300 mg或150 mg皮下注射,持续治疗4周,此后每4周给药一次。主要终点是接受可善挺®300 mg治疗的患者在第12周实现ASAS20缓解的比率。关键次要终点是在证明可善挺®300 mg的优势之后,接受可善挺®150 mg治疗的患者在第12周实现ASAS20缓解的比率。在第12周时,安慰剂组患者被重新随机分入皮下注射可善挺®300mg或150mg组2。
达到ASAS20需要在以下至少三个方面中实现至少20%的改善和百分制下至少10分的改进:患者总体评估、疼痛评估、功能(Bath 强直性脊柱炎功能指数(BASFI))和炎症11。
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。
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关于诺华
诺华正在通过创想医药未来以改善人们生活质量、延长人类寿命。作为全球知名的医药健康企业,我们运用创新科学和数字化技术,在医药健康需求增长的领域创造变革性的治疗方法。在探索新药物的过程中,我们不懈创新,对研发的投资一直处于行业全球先列。在全球,超过7.5亿患者受益于诺华产品,同时,我们持续探索更多创新方式使我们的创新疗法造福更多患者。诺华在全球拥有来自超过140个国家的约10.5万名员工。如需更多信息,敬请登录公司网站:www.novartis.com 。
关于诺华中国
“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务,致力于提高中国人民的健康水平和生活质量。诺华在中国的业务包括诺华肿瘤、诺华制药和山德士,全国建有三大生产基地,并在北京、上海和江苏设立了研发机构。从研发到生产销售,诺华以多元化的业务组合,全面服务中国老百姓的健康。目前,诺华在中国拥有9100多名员工。如需更多信息,敬请登录公司中文网站http://www.novartis.com.cn。
参考资料
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