瑞士巴塞尔2019年3月5日电 /美通社/ -- 2019年3月4日，诺华公布了一项有关中国患者使用司库奇尤单抗（俗称“苏金单抗”）治疗中至重度斑块状银屑病有效性及安全性的最新III期研究数据。该III期研究是一项随机、双盲、安慰剂对照、国际多中心研究，为期52周，入组患者543名。此次公布的是该研究中针对441位中国患者的数据。
数据显示，在所有接受司库奇尤单抗300毫克治疗的中国患者中，分别有97.7％和80.9％的患者在第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％的患者在第16周达到PASI 90[1]。
“这次中国临床试验的数据非常喜人，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治疗带来革命性变化，将推动中国银屑病治疗策略的整体转变。首先，它有助于整体治疗目标的提升，有望将银屑病治疗目标从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治疗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治疗的一线药物，这样可使更多中重度银屑病患者及早获得更好更安全的治疗。”
“诺华始终致力于帮助银屑病患者实现心中所愿 -- 创想医药，带来可实现皮损清除及全面获益的治疗方式，”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，“我们很高兴能首次发布有关中国患者的喜人数据，并看到这些数据为司库奇尤单抗在银屑病治疗的独特优势地位提供有力印证。”
全球100项临床研究中积累的大量数据证明了在每10位患者中有8位可通过16周司库奇尤单抗治疗实现皮损清除或几乎清除[3]。患者应答率可近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）的治疗中体现出快速、持久的疗效及安全性[5,6]。
* 司库奇尤单抗（俗称“苏金单抗”）尚未在中国获批上市。 |
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]。通过直接作用于不同来源的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名患者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多个国家和地区批准上市，拥有100项真实世界和临床研究支持[2,18]。
参考数据 |
[1] Jianzhong, J et al. Secukinumab 300 mg showed faster and 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 and 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, 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. |
[6] 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. |
[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 and 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 and 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 and 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 and 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 and not yet recruiting and completed. This list excludes all trials listed as suspended, terminated and withdrawn |
