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）獲得國家藥品監督管理局批準，用于常規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癥，也是目前國內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。
研究發現，白介素-17A（IL-17A）是促進炎癥級聯反應、新骨生成、最終導致骨融合和完全強直的重要介質。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量。可善挺®強直適應癥的獲批有望為數百萬中國強直患者帶來全新的治療方案和健康希望，使諾華創新藥物惠及更廣泛的中國患者。”
強直性脊柱炎疾病負擔沉重，“抑制骨結構進展”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，患病人數約在300萬左右2。發病年齡通常在13-31歲，且多見于男性1。數據顯示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構損傷。
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發生炎癥，生出病理性新骨。健康的韌帶逐漸開始骨化，產生骨贅、連成骨橋，最終導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構損傷以及進一步加重的風險。
301醫院風濕科主任醫師黃烽教授介紹：“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。但近些年有研究發現，即使炎癥水平得到控制，依然會存在骨結構損傷進一步惡化的情況。如何雙管齊下，特別是‘抑制骨結構進展’成為了亟待滿足的治療需求。”
全新靶點IL-17A“瞄準”骨結構進展，推動中國強直性脊柱炎生物制劑治療挺進全新時代
強直性脊柱炎從發病到最終骨融合，會經歷幾大階段：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，而IL-17A是個重要的“助推器”。一方面，它是附著點炎發病過程中的關鍵細胞因子和炎癥介質，可進一步促進炎癥級聯反應；另一方面，它是骨重塑的關鍵介質，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構進一步損傷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期臨床研究負責人，黃烽教授介紹：“司庫奇尤單抗的出現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域的臨床表現和潛力充滿期待。希望看到更多中國患者能獲益于新一代的創新藥物！”
目前，可善挺®已在包括歐盟國家和美國在內的多個國家和地區上市，批準用于治療銀屑病、銀屑病關節炎及強直性脊柱炎19,20,21,22，擁有5年持續性療效和安全性數據支持23,24,25，惠及全球超過30萬患者26。
* 銀屑病關節炎適應癥尚未在中國大陸獲批。
** 欲了解更多有關可善挺®（司庫奇尤單抗）產品信息及安全性數據，請前往諾華中國官網（www.novartis.com.cn）搜索“可善挺”或“司庫奇尤單抗”獲取處方信息。
1 中華醫學會風濕病學分會. 強直性脊柱炎診斷及治療指南. 中國風濕病學雜志，2010，14(8):557-560.
2 根據國家統計局官網公布的2010年第六次人口普查數據，我國成年人口數約10.5億。以此數據為基礎進行匡算。
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，《中山大學學報：醫學科學版》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.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
