注册| 登录
关注顶部
您现在位置:亚洲城在线 >>药讯新闻 >>新药快讯 >> 浏览文章

诺华会员Cosentyx手机版斑块型银屑病中国网页版数据

会员日期:2019-03-05 来源:互联网 编辑:亚洲城在线浏览数:(0) 加入收藏

cosentyx.jpg

数据。

数据显示,在所有接受司库奇尤单抗300毫克手机版的中国网页版中,分别有97.7%和80.9%的网页版在第12周达到了PASI 75(即银屑病面积和严重性指数改善75%)和PASI 90,87%的网页版在第16周达到PASI 90[1]。

“这次中国4850ca88的数据非常喜人,在疗效和安全性方面甚至优于一些国际数据。”中华医学会皮肤性病学分会前任主任委员张建中教授作为此次III期研究项目负责人表示:“这一结果或将为中国银屑病手机版带来革命性变化,将推动中国银屑病手机版策略的整体转变。首先,它有助于整体手机版目标的提升,有望将银屑病手机版目标从PASI 75提高到PASI 90甚至PASI 100;其次,这次III期研究体现了司库奇尤单抗很好的安全性。过去生物制剂仅在光疗及系统性手机版无效后才被考虑使用,但未来这个顺序很可能被改写,生物制剂有可能成为系统手机版的一线亚洲城,这样可使更多中重度银屑病网页版及早获得更好更安全的手机版。”

“诺华始终致力于帮助银屑病网页版实现心中所愿 -- 创想医药,带来可实现皮损清除及全面获益的手机版方式,”诺华免疫学、肝病和皮肤病学全球开发部门负责人、中国地区开发负责人Eric Hughes先生表示,“我们很高兴能首次会员有关中国网页版的喜人数据,并看到这些数据为司库奇尤单抗在银屑病手机版的独特优势地位提供有力印证。”

全球100项4850研究中积累的大量数据证明了在每10位网页版中有8位可通过16周司库奇尤单抗手机版实现皮损清除或几乎清除[3]。网页版应答率可近100%维持长达5年[4]。它是一种中和IL-17A的全人源单克隆抗体,在中至重度银屑病、关节型银屑病以及其它部位银屑病(头皮、掌跖和指(趾)甲银屑病)的手机版中体现出快速、持久的疗效及安全性[5,6]。

关于司库奇尤单抗

司库奇尤单抗是目前首个也是唯一一个能特异性抑制白细胞介素17A(IL-17A)的全人源化生物制剂。IL-17A是参与银屑病(PsO)、关节病型银屑病(PsA)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[7-10]。IL-17A可以由IL-23依赖性和IL-23非依赖性两种途径产生,由先天免疫系统(可由机械应激触发)和适应性免疫系统的多种细胞产生[11]。通过直接作亚洲城不同来源的IL-17A,司库奇尤单抗可抑制这一起基石作用的细胞因子[8]。 

作为一个成熟产品,司库奇尤单抗拥有三大适应症(PsO、PsA、AS)以及超过200,000名网页版5年持续性疗效和安全性数据支持[2,6,12,13]。司库奇尤单抗拥有快速长期的疗效以及高度稳定的良好安全性,几乎无注射部位反应或疼痛[6,12,14-17]。目前已在包括欧盟国家和美国在内的80多个国家和地区ca88登陆,拥有100项真实世界和4850研究支持[2,18]。

参考数据

[1]     Jianzhong, J et al. Secukinumab 300 mg showed faster higher efficacy in Chinese moderate to severe plaque psoriasis patients. Presented as poster 10499 at the American Academy of Dermatology (AAD) Annual Meeting. March 2019.

[2]     Novartis, data on file. February 2019.

[3]     Blauvelt, A et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. JAAD 2017;76(1):60-69.

[4]     Bissonnette R et al. Secukinumab demonstrates high sustained efficacy a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th September 2017

[5]     Reich, K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, 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.

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

[7]     EU Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed September 2018.

[8]     Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 Beyond. Arthritis Rheumatol. 2014;66:231–41.

[9]     Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496–509.

[10]   Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717–24.

[11]   Schett G et al. Enthesitis: from pathophysiology to treatment. Nat Rev Rheumatol. 2017 Nov 21;3(12):731-741.

[12]   Bissonnette R et al. Secukinumab Demonstrates High Sustained Efficacy a Favorable Safety Profile Through 5 years of Treatment in Moderate to Severe Psoriasis. Presented as a Late Breaking Poster #7 at the 3rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 2018.

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

[14]   Braun J et al. Secukinumab demonstrates low radiographic progression sustained efficacy through 4 years in patients with active ankylosing spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual Meeting, San Diego, USA. 7th November 2017.

[15]   Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534–48.

[16]   McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386(9999):1137–1146.

[17]   Reich K et al. Secukinumab, a fully human anti‐interleukin‐17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate‐to‐severe plaque psoriasis. Br. J. Dermatol. 2017;176:752–58.

[18]   Clinicaltrials.gov. Active trials include all those that are listed as recruiting, active but not recruiting, enrolling by invitation not yet recruiting completed. This list excludes all trials listed as suspended, terminated withdrawn


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。作为全球领先的医药健康企业,我们运用创新科学和数字化技术手段,在医药健康需求增长的领域创造变革性的手机版方法。在探索新亚洲城的过程中,我们不懈创新,对研发的投资亦一直处于行业全球先列。在全球,有超过8亿网页版受益于诺华产品,同时,我们还在持续探索更多创新方式使我们的变革性手机版手段造福更多网页版。诺华在全球拥有超过来自150个国家的近13万名员工。

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、山德士和爱尔康,全国建有三大生产基地,并在上海和江苏设立了两大研发中心。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。

0
关键字:
上一篇: 会员潜在重磅产品Skyrizi获欧盟CHMP支持ca88,手机版斑块型银屑病
下一篇:FDA受理流感药Xofluza亚洲城流感并发症高危人群补充新药申请

网友评论

 
关于本站- 与我联系- 网站地图- 友情链接
奔驰宝马娱乐平台网站乐天堂Fun88国际官方网千赢国际app登录