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(xiàng)有關(guān)中國(guó)患者使用司庫(kù)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(shù)據(jù)。該III期研究是一項(xiàng)隨機(jī)、雙盲、安慰劑對(duì)照、國(guó)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(duì)441位中國(guó)患者的數(shù)據(jù)。
數(shù)據(jù)顯示，在所有接受司庫(kù)奇尤單抗300毫克治療的中國(guó)患者中，分別有97.7％和80.9％的患者在第12周達(dá)到了PASI 75（即銀屑病面積和嚴(yán)重性指數(shù)改善75%）和PASI 90，87％的患者在第16周達(dá)到PASI 90[1]。
“這次中國(guó)臨床試驗(yàn)的數(shù)據(jù)非常喜人，在療效和安全性方面甚至優(yōu)于一些國(guó)際數(shù)據(jù)。”中華醫(yī)學(xué)會(huì)皮膚性病學(xué)分會(huì)前任主任委員張建中教授作為此次III期研究項(xiàng)目負(fù)責(zé)人表示：“這一結(jié)果或?qū)橹袊?guó)銀屑病治療帶來(lái)革命性變化，將推動(dòng)中國(guó)銀屑病治療策略的整體轉(zhuǎn)變。首先，它有助于整體治療目標(biāo)的提升，有望將銀屑病治療目標(biāo)從PASI 75提高到PASI 90甚至PASI 100；其次，這次III期研究體現(xiàn)了司庫(kù)奇尤單抗很好的安全性。過去生物制劑僅在光療及系統(tǒng)性治療無(wú)效后才被考慮使用，但未來(lái)這個(gè)順序很可能被改寫，生物制劑有可能成為系統(tǒng)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?！?/p>
“諾華始終致力于幫助銀屑病患者實(shí)現(xiàn)心中所愿 -- 創(chuàng)想醫(yī)藥，帶來(lái)可實(shí)現(xiàn)皮損清除及全面獲益的治療方式，”諾華免疫學(xué)、肝病和皮膚病學(xué)全球開發(fā)部門負(fù)責(zé)人、中國(guó)地區(qū)開發(fā)負(fù)責(zé)人Eric Hughes先生表示，“我們很高興能首次發(fā)布有關(guān)中國(guó)患者的喜人數(shù)據(jù)，并看到這些數(shù)據(jù)為司庫(kù)奇尤單抗在銀屑病治療的獨(dú)特優(yōu)勢(shì)地位提供有力印證?！?/p>
全球100項(xiàng)臨床研究中積累的大量數(shù)據(jù)證明了在每10位患者中有8位可通過16周司庫(kù)奇尤單抗治療實(shí)現(xiàn)皮損清除或幾乎清除[3]。患者應(yīng)答率可近100%維持長(zhǎng)達(dá)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(guān)節(jié)型銀屑病以及其它部位銀屑?。^皮、掌跖和指（趾）甲銀屑?。┑闹委熤畜w現(xiàn)出快速、持久的療效及安全性[5,6]。
* 司庫(kù)奇尤單抗（俗稱“蘇金單抗”）尚未在中國(guó)獲批上市。 |
關(guān)于司庫(kù)奇尤單抗
司庫(kù)奇尤單抗是目前首個(gè)也是唯一一個(gè)能特異性抑制白細(xì)胞介素17A（IL-17A）的全人源化生物制劑。IL-17A是參與銀屑?。≒sO）、關(guān)節(jié)病型銀屑?。≒sA）和強(qiáng)直性脊柱炎（AS）炎癥產(chǎn)生及疾病進(jìn)展的核心致病因子，在發(fā)病機(jī)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(chǎn)生，由先天免疫系統(tǒng)（可由機(jī)械應(yīng)激觸發(fā)）和適應(yīng)性免疫系統(tǒng)的多種細(xì)胞產(chǎn)生[11]。通過直接作用于不同來(lái)源的IL-17A，司庫(kù)奇尤單抗可抑制這一起基石作用的細(xì)胞因子[8]。
作為一個(gè)成熟產(chǎn)品，司庫(kù)奇尤單抗擁有三大適應(yīng)癥（PsO、PsA、AS）以及超過200,000名患者5年持續(xù)性療效和安全性數(shù)據(jù)支持[2,6,12,13]。司庫(kù)奇尤單抗擁有快速長(zhǎng)期的療效以及高度穩(wěn)定的良好安全性，幾乎無(wú)注射部位反應(yīng)或疼痛[6,12,14-17]。目前已在包括歐盟國(guó)家和美國(guó)在內(nèi)的80多個(gè)國(guó)家和地區(qū)批準(zhǔn)上市，擁有100項(xiàng)真實(shí)世界和臨床研究支持[2,18]。
參考數(shù)據(jù) |
[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 |
