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

星期一, 2019, 6月 17 - 08:47
  • 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。

   

  

免责声明

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,”  “can,”  “will,”  “plan,”  “expect,”  “anticipate,”  “look forward,”  “believe,”  “committed,”  “investigational,”  “pipeline,”  “launch,”  or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

   

  

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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[8] Scotti L et al. Prevalence and incidence of psoriatic arthritis: A systematic review and meta-analysis. Science Direct. 2018;48:28-34.

[9] Mease PJ et al. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs 2014;74:423-41.

[10] Liu J.T et al. Psoriatic arthritis: Epidemiology, diagnosis, and treatment. World JOrthop. 2014; 5(4): 537-543. 

[11] Landewe R and Van Tubergen A. Clinical tools to assess and monitor spondyloarthritis. Curr Rhen Rep 2015;17(7):47

[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].

[13] Reich, K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled Randomized Trials. Presented as a Late Breaking Poster #6 at the 3rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 2018.

[14] Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.

[15] Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.

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