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諾華可善挺(司庫奇尤單抗)強直性脊柱炎適應(yīng)癥獲批

強直性脊柱炎生物制劑治療挺進全新“白介素時代”
為更多中國患者“骨”起治療新希望
諾華
2020-04-28 18:04 12549
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。

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,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,這也標志著諾華在中國進入風濕疾病領(lǐng)域。強直性脊柱炎多起病于中青年,疾病嚴重影響了患者的行動能力和生活質(zhì)量??缮仆?sup>®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擔沉重,“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,說明相當比例的患者都存在骨結(jié)構(gòu)損傷以及進一步加重的風險。 

301醫(yī)院風濕科主任醫(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?!?/p>

全新靶點IL-17A“瞄準”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。“新骨形成”是整個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:

  • 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處于整個炎癥通路的下游,且全人源制備工藝降低了不良反應(yīng)風險。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)報道17,5年抗藥抗體發(fā)生率<1%18

作為司庫奇尤單抗中國III期臨床研究負責人,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)搜索可善挺司庫奇尤單抗獲取處方信息。

1 中華醫(yī)學(xué)會風濕病學(xué)分會. 強直性脊柱炎診斷及治療指南. 中國風濕病學(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
6 Lories R, Melones 1B. Nature Medicine 2012-18:1018-19
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.
9 Bidad K et al. Nat Rev Rheumatol. 2017 Jul;13(7):410-420.
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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消息來源:諾華
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