瑞士巴塞爾2019年3月5日電 /美通社/ -- 2019年3月4日，諾華公布了一項有關中國患者使用司庫奇尤單抗（俗稱“蘇金單抗”）治療中至重度斑塊狀銀屑病有效性及安全性的最新III期研究數據。該III期研究是一項隨機、雙盲、安慰劑對照、國際多中心研究，為期52周，入組患者543名。此次公布的是該研究中針對441位中國患者的數據。
數據顯示，在所有接受司庫奇尤單抗300毫克治療的中國患者中，分別有97.7％和80.9％的患者在第12周達到了PASI 75（即銀屑病面積和嚴重性指數改善75%）和PASI 90，87％的患者在第16周達到PASI 90[1]。
“這次中國臨床試驗的數據非常喜人，在療效和安全性方面甚至優于一些國際數據。”中華醫學會皮膚性病學分會前任主任委員張建中教授作為此次III期研究項目負責人表示：“這一結果或將為中國銀屑病治療帶來革命性變化，將推動中國銀屑病治療策略的整體轉變。首先，它有助于整體治療目標的提升，有望將銀屑病治療目標從PASI 75提高到PASI 90甚至PASI 100；其次，這次III期研究體現了司庫奇尤單抗很好的安全性。過去生物制劑僅在光療及系統性治療無效后才被考慮使用，但未來這個順序很可能被改寫，生物制劑有可能成為系統治療的一線藥物，這樣可使更多中重度銀屑病患者及早獲得更好更安全的治療。”
“諾華始終致力于幫助銀屑病患者實現心中所愿 -- 創想醫藥，帶來可實現皮損清除及全面獲益的治療方式，”諾華免疫學、肝病和皮膚病學全球開發部門負責人、中國地區開發負責人Eric Hughes先生表示，“我們很高興能首次發布有關中國患者的喜人數據，并看到這些數據為司庫奇尤單抗在銀屑病治療的獨特優勢地位提供有力印證。”
全球100項臨床研究中積累的大量數據證明了在每10位患者中有8位可通過16周司庫奇尤單抗治療實現皮損清除或幾乎清除[3]。患者應答率可近100%維持長達5年[4]。它是一種中和IL-17A的全人源單克隆抗體，在中至重度銀屑病、關節型銀屑病以及其它部位銀屑病（頭皮、掌跖和指（趾）甲銀屑病）的治療中體現出快速、持久的療效及安全性[5,6]。
* 司庫奇尤單抗（俗稱“蘇金單抗”）尚未在中國獲批上市。 |
關于司庫奇尤單抗
司庫奇尤單抗是目前首個也是唯一一個能特異性抑制白細胞介素17A（IL-17A）的全人源化生物制劑。IL-17A是參與銀屑病（PsO）、關節病型銀屑病（PsA）和強直性脊柱炎（AS）炎癥產生及疾病進展的核心致病因子，在發病機制中起基石作用[7-10]。IL-17A可以由IL-23依賴性和IL-23非依賴性兩種途徑產生，由先天免疫系統（可由機械應激觸發）和適應性免疫系統的多種細胞產生[11]。通過直接作用于不同來源的IL-17A，司庫奇尤單抗可抑制這一起基石作用的細胞因子[8]。
作為一個成熟產品，司庫奇尤單抗擁有三大適應癥（PsO、PsA、AS）以及超過200,000名患者5年持續性療效和安全性數據支持[2,6,12,13]。司庫奇尤單抗擁有快速長期的療效以及高度穩定的良好安全性，幾乎無注射部位反應或疼痛[6,12,14-17]。目前已在包括歐盟國家和美國在內的80多個國家和地區批準上市，擁有100項真實世界和臨床研究支持[2,18]。
參考數據 |
[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 |
