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　　4月28日，諾華制藥（中國(guó)）宣布，可善挺^®（司庫奇尤單抗）獲得國(guó)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(qiáng)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(guó)獲批的第二個(gè)適應(yīng)癥，也是目前國(guó)內(nèi)首個(gè)且唯一被批準(zhǔn)用于治療強(qiáng)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(jìn)炎癥級(jí)聯(lián)反應(yīng)、新骨生成、最終導(dǎo)致骨融合和完全強(qiáng)直的重要介質(zhì)。作為目前全球首個(gè)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(jìn)展。 

　　諾華制藥（中國(guó)）總裁張穎女士表示：“我非常高興可善挺^®能獲批用于中國(guó)強(qiáng)直性脊柱炎患者的治療，這也標(biāo)志著諾華在中國(guó)進(jìn)入風(fēng)濕疾病領(lǐng)域。強(qiáng)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(dòng)能力和生活質(zhì)量�？缮仆�^®強(qiáng)直適應(yīng)癥的獲批有望為數(shù)百萬中國(guó)強(qiáng)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(guó)患者�！�

　　強(qiáng)直性脊柱炎疾病負(fù)擔(dān)沉重，“抑制骨結(jié)構(gòu)進(jìn)展”治療需求亟待滿足

　　強(qiáng)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(guó)，強(qiáng)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(qiáng)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(dá)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(yùn)動(dòng)。韌帶與上下椎體骨的連接點(diǎn)被稱為附著點(diǎn)，而強(qiáng)直性脊柱炎患者的附著點(diǎn)處會(huì)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(qiáng)直和不同程度的殘疾。一項(xiàng)中國(guó)研究顯示⁵，超過65%的患者伴有至少一個(gè)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(jìn)一步加重的風(fēng)險(xiǎn)。 

　　301醫(yī)院風(fēng)濕科主任醫(yī)師黃烽教授介紹：“強(qiáng)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(diǎn)。但近些年有研究發(fā)現(xiàn)，即使炎癥水平得到控制，依然會(huì)存在骨結(jié)構(gòu)損傷進(jìn)一步惡化的情況。如何雙管齊下，特別是‘抑制骨結(jié)構(gòu)進(jìn)展’成為了亟待滿足的治療需求。”

　　全新靶點(diǎn)IL-17A“瞄準(zhǔn)”骨結(jié)構(gòu)進(jìn)展，推動(dòng)中國(guó)強(qiáng)直性脊柱炎生物制劑治療挺進(jìn)全新時(shí)代

　　強(qiáng)直性脊柱炎從發(fā)病到最終骨融合，會(huì)經(jīng)歷幾大階段：骨炎-脂肪沉積-骨贅-骨橋-骨融合。“新骨形成”是整個(gè)病程進(jìn)展的病理基礎(chǔ)，而IL-17A是個(gè)重要的“助推器”。一方面，它是附著點(diǎn)炎發(fā)病過程中的關(guān)鍵細(xì)胞因子和炎癥介質(zhì)，可進(jìn)一步促進(jìn)炎癥級(jí)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(shí)抑制新骨形成來阻止骨結(jié)構(gòu)進(jìn)一步損傷¹¹。

　　作為目前全球首個(gè)且唯一全人源IL-17A抑制劑，多項(xiàng)臨床研究證實(shí)了可善挺^®的多重獲益：

• 快速緩解背痛、晨僵和疲乏癥狀：MEASURE 2研究結(jié)果顯示^12,13，患者接受150mg可善挺^®治療4周，背痛較基線改善39%（安慰劑組：15%），晨僵較基線改善34.4%（安慰劑組：14.8%），疲勞較基線改善28%（安慰劑組：8%）。
• 抑制新骨形成，阻止結(jié)構(gòu)損傷：持續(xù)接受可善挺^®治療，97%基線無骨贅患者和73%基線有骨贅患者2年內(nèi)無新生骨贅¹⁴，近80%患者脊柱損傷在4年內(nèi)未出現(xiàn)惡化¹⁵。
• 良好整體安全性和耐受性：IL-17A處于整個(gè)炎癥通路的下游，且全人源制備工藝降低了不良反應(yīng)風(fēng)險(xiǎn)。研究顯示，經(jīng)可善挺^®治療的患者尚無結(jié)核易感性增加的報(bào)告¹⁶，且目前尚未見經(jīng)可善挺^®治療出現(xiàn)乙肝再激活的相關(guān)報(bào)道¹⁷，5年抗藥抗體發(fā)生率<1%¹⁸。

　　作為司庫奇尤單抗中國(guó)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(gè)全新的治療選擇和希望，也讓我們對(duì)IL-17A這一新靶點(diǎn)在強(qiáng)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(guó)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(guó)家和美國(guó)在內(nèi)的多個(gè)國(guó)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(qiáng)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(guó)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(qǐng)前往諾華中國(guó)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(huì)風(fēng)濕病學(xué)分會(huì). 強(qiáng)直性脊柱炎診斷及治療指南. 中國(guó)風(fēng)濕病學(xué)雜志，2010，14(8):557-560.
²根據(jù)國(guó)家統(tǒng)計(jì)局官網(wǎng)公布的2010年第六次人口普查數(shù)據(jù)，我國(guó)成年人口數(shù)約10.5億。以此數(shù)據(jù)為基礎(chǔ)進(jìn)行匡算。
³Ward MM. Arthritis Care Res. 1999:12(4):247-255.
⁴Druce KL et al. Arthritis Res Ther. 2018;20(l):96.
⁵涂柳丹 等，《中山大學(xué)學(xué)報(bào)：醫(yī)學(xué)科學(xué)版》2015年 第1期
⁶Lories R, Melones 1B. Nature Medicine 2012-18:1018-19
⁷Patel DD, et al. Ann Rheum Dis. 2013;72 (Suppl 2), ii116-23.
⁸Moynes DM et al. Brain Behav Immun. 2014 Oct;41:1-9.
⁹Bidad K et al. Nat Rev Rheumatol. 2017 Jul;13(7):410-420.
¹⁰Sun C et al. Mol Med Rep. 2017 Jan;15(1):89-96.
¹¹Koenders MI, et al. Drug Des Devel Ther. 2016 Jun 24;102069-80.
¹²Deodhar A,et al. Clin Exp Rheumatol. 2019 Mar-Apr;37(2):260-269.
¹³Marzo-Ortega et al. 2019 ACR Annual Meeting. Poster 1504
¹⁴Braun J et al. Ann Rheum Dis. 2017;76(6):1070-1077 and Supplementary Tables
¹⁵Braun J et al. Rheumatology (Oxford). 2019;58(5):859-868.
¹⁶Hannah A. Blair. Drugs (2019) 79:433–443
¹⁷PubMed檢索（201501-202002）結(jié)果截圖
¹⁸Reich K et al. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.
¹⁹Novartis 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].       
²⁰Girolomoni G, et al. Psoriasis: Rationale for targeting interleukin-17. Br J Dermatol 2012;167:717–724.
²¹Sieper J, et al. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol 2019; 15:747–757.
²²Brembilla 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.
²³Baraliakos 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.
²⁴Bissonnette 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.
²⁵Mease 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].
²⁶Novartis data on file.

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