上海2020年4月28日 /美通社/ -- 今天，諾華制藥（中國）宣布，可善挺® （司庫奇尤單抗）獲得國家藥品監(jiān)督管理局批準(zhǔn)，用于常規(guī)治療療效欠佳的強直性脊柱炎的成年患者。這是可善挺®繼2019年3月批準(zhǔn)用于治療中重度斑塊狀銀屑病之后在中國獲批的第二個適應(yīng)癥，也是目前國內(nèi)首個且唯一被批準(zhǔn)用于治療強直性脊柱炎的白介素類抑制劑。
研究發(fā)現(xiàn)，白介素-17A（IL-17A）是促進炎癥級聯(lián)反應(yīng)、新骨生成、最終導(dǎo)致骨融合和完全強直的重要介質(zhì)。作為目前全球首個且唯一全人源IL-17A抑制劑，可善挺®可特異性阻斷任何來源的IL-17A，有效控制炎癥并抑制新骨形成，多層調(diào)控病理進展。
諾華制藥（中國）總裁張穎女士表示：“我非常高興可善挺®能獲批用于中國強直性脊柱炎患者的治療，這也標(biāo)志著諾華在中國進入風(fēng)濕疾病領(lǐng)域。強直性脊柱炎多起病于中青年，疾病嚴(yán)重影響了患者的行動能力和生活質(zhì)量。可善挺®強直適應(yīng)癥的獲批有望為數(shù)百萬中國強直患者帶來全新的治療方案和健康希望，使諾華創(chuàng)新藥物惠及更廣泛的中國患者?！?/p>
強直性脊柱炎疾病負(fù)擔(dān)沉重，“抑制骨結(jié)構(gòu)進展”治療需求亟待滿足
強直性脊柱炎是一種慢性炎癥性疾病，屬于風(fēng)濕免疫病。在我國，強直性脊柱炎患病率約為0.3%1，患病人數(shù)約在300萬左右2。發(fā)病年齡通常在13-31歲，且多見于男性1。數(shù)據(jù)顯示3,4，約80%的強直性脊柱炎患者存在脊柱疼痛和疲勞癥狀，晨僵比例更是高達90%。但真正可怕的還是它可能帶來的骨結(jié)構(gòu)損傷。
正常情況下，人體脊柱椎體由柔韌的韌帶連接，因此腰背部可以靈活運動。韌帶與上下椎體骨的連接點被稱為附著點，而強直性脊柱炎患者的附著點處會反復(fù)發(fā)生炎癥，生出病理性新骨。健康的韌帶逐漸開始骨化，產(chǎn)生骨贅、連成骨橋，最終導(dǎo)致脊柱融合強直和不同程度的殘疾。一項中國研究顯示5，超過65%的患者伴有至少一個韌帶骨贅，說明相當(dāng)比例的患者都存在骨結(jié)構(gòu)損傷以及進一步加重的風(fēng)險。
301醫(yī)院風(fēng)濕科主任醫(yī)師黃烽教授介紹：“強直性脊柱炎作為一種炎癥性疾病，抑制炎癥水平很重要，也是目前臨床藥物治療的重點。但近些年有研究發(fā)現(xiàn)，即使炎癥水平得到控制，依然會存在骨結(jié)構(gòu)損傷進一步惡化的情況。如何雙管齊下，特別是‘抑制骨結(jié)構(gòu)進展’成為了亟待滿足的治療需求。”
全新靶點IL-17A“瞄準(zhǔn)”骨結(jié)構(gòu)進展，推動中國強直性脊柱炎生物制劑治療挺進全新時代
強直性脊柱炎從發(fā)病到最終骨融合，會經(jīng)歷幾大階段：骨炎-脂肪沉積-骨贅-骨橋-骨融合?！靶鹿切纬伞笔钦麄€病程進展的病理基礎(chǔ)，而IL-17A是個重要的“助推器”。一方面，它是附著點炎發(fā)病過程中的關(guān)鍵細(xì)胞因子和炎癥介質(zhì)，可進一步促進炎癥級聯(lián)反應(yīng)；另一方面，它是骨重塑的關(guān)鍵介質(zhì)，參與新骨形成6。因此，抑制IL-17A可阻斷炎癥通路7、緩解疼痛8,9,10，同時抑制新骨形成來阻止骨結(jié)構(gòu)進一步損傷11。
作為目前全球首個且唯一全人源IL-17A抑制劑，多項臨床研究證實了可善挺®的多重獲益：
作為司庫奇尤單抗中國III期臨床研究負(fù)責(zé)人，黃烽教授介紹：“司庫奇尤單抗的出現(xiàn)無疑為患者提供了一個全新的治療選擇和希望，也讓我們對IL-17A這一新靶點在強直性脊柱炎領(lǐng)域的臨床表現(xiàn)和潛力充滿期待。希望看到更多中國患者能獲益于新一代的創(chuàng)新藥物！”
目前，可善挺®已在包括歐盟國家和美國在內(nèi)的多個國家和地區(qū)上市，批準(zhǔn)用于治療銀屑病、銀屑病關(guān)節(jié)炎及強直性脊柱炎19,20,21,22，擁有5年持續(xù)性療效和安全性數(shù)據(jù)支持23,24,25，惠及全球超過30萬患者26。
* 銀屑病關(guān)節(jié)炎適應(yīng)癥尚未在中國大陸獲批。
** 欲了解更多有關(guān)可善挺®（司庫奇尤單抗）產(chǎn)品信息及安全性數(shù)據(jù)，請前往諾華中國官網(wǎng)（www.novartis.com.cn）搜索“可善挺”或“司庫奇尤單抗”獲取處方信息。
1 中華醫(yī)學(xué)會風(fēng)濕病學(xué)分會. 強直性脊柱炎診斷及治療指南. 中國風(fēng)濕病學(xué)雜志，2010，14(8):557-560.
2 根據(jù)國家統(tǒng)計局官網(wǎng)公布的2010年第六次人口普查數(shù)據(jù)，我國成年人口數(shù)約10.5億。以此數(shù)據(jù)為基礎(chǔ)進行匡算。
3 Ward MM. Arthritis Care Res. 1999:12(4):247-255.
4 Druce KL et al. Arthritis Res Ther. 2018;20(l):96.
5 涂柳丹 等，《中山大學(xué)學(xué)報：醫(yī)學(xué)科學(xué)版》2015年 第1期
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7 Patel DD, et al. Ann Rheum Dis. 2013;72 (Suppl 2), ii116-23.
8 Moynes DM et al. Brain Behav Immun. 2014 Oct;41:1-9.
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10 Sun C et al. Mol Med Rep. 2017 Jan;15(1):89-96.
11 Koenders MI, et al. Drug Des Devel Ther. 2016 Jun 24;102069-80.
12 Deodhar A,et al. Clin Exp Rheumatol. 2019 Mar-Apr;37(2):260-269.
13 Marzo-Ortega et al. 2019 ACR Annual Meeting. Poster 1504
14 Braun J et al. Ann Rheum Dis. 2017;76(6):1070-1077 and Supplementary Tables
15 Braun J et al. Rheumatology (Oxford). 2019;58(5):859-868.
16 Hannah A. Blair. Drugs (2019) 79:433–443
17 PubMed檢索（201501-202002）結(jié)果截圖
18 Reich K et al. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.
19 Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124 [Last accessed: January 2020].
20 Girolomoni G, et al. Psoriasis: Rationale for targeting interleukin-17. Br J Dermatol 2012;167:717–724.
21 Sieper J, et al. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol 2019; 15:747–757.
22 Brembilla NC, Senra L, Boehncke W-H. The IL-17 Family of Cytokines in Psoriasis: IL-17A and Beyond. Front. Immunol. 9:1682. doi: 10.3389/fimmu.2018.01682.
23 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; October 19–24, 2018; Chicago, IL.
24 Bissonnette R, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. J Eur Acad Dermatol Venereol 2018;32:1507–1514.
25 Mease PJ, et al. Secukinumab provides sustained improvements in the signs and symptoms of psoriatic arthritis: Final 5-year results from the Phase 3 FUTURE 1 study. ACR Open Rheumatol 2019. doi: 10.1002/acr2.11097 [Epub ahead of print].
26 Novartis data on file.
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