4月28日，诺华制药（中国）宣布，可善挺^®（司库奇尤单抗）获得国家药品监督管理局批准，用于常规治疗疗效欠佳的强直性脊柱炎的成年患者。这是可善挺^®继2019年3月批准用于治疗中重度斑块状银屑病之后在中国获批的第二个适应症，也是目前国内首个且唯一被批准用于治疗强直性脊柱炎的白介素类抑制剂。

　　研究发现，白介素-17A（IL-17A）是促进炎症级联反应、新骨生成、最终导致骨融合和完全强直的重要介质。作为目前全球首个且唯一全人源IL-17A抑制剂，可善挺^®可特异性阻断任何来源的IL-17A，有效控制炎症并抑制新骨形成，多层调控病理进展。 

　　诺华制药（中国）总裁张颖女士表示：“我非常高兴可善挺^®能获批用于中国强直性脊柱炎患者的治疗，这也标志着诺华在中国进入风湿疾病领域。强直性脊柱炎多起病于中青年，疾病严重影响了患者的行动能力和生活质量。可善挺^®强直适应症的获批有望为数百万中国强直患者带来全新的治疗方案和健康希望，使诺华创新药物惠及更广泛的中国患者。”

　　强直性脊柱炎疾病负担沉重，“抑制骨结构进展”治疗需求亟待满足

　　强直性脊柱炎是一种慢性炎症性疾病，属于风湿免疫病。在我国，强直性脊柱炎患病率约为0.3%¹，患病人数约在300万左右²。发病年龄通常在13-31岁，且多见于男性¹。数据显示^3,4，约80%的强直性脊柱炎患者存在脊柱疼痛和疲劳症状，晨僵比例更是高达90%。但真正可怕的还是它可能带来的骨结构损伤。

　　正常情况下，人体脊柱椎体由柔韧的韧带连接，因此腰背部可以灵活运动。韧带与上下椎体骨的连接点被称为附着点，而强直性脊柱炎患者的附着点处会反复发生炎症，生出病理性新骨。健康的韧带逐渐开始骨化，产生骨赘、连成骨桥，最终导致脊柱融合强直和不同程度的残疾。一项中国研究显示⁵，超过65%的患者伴有至少一个韧带骨赘，说明相当比例的患者都存在骨结构损伤以及进一步加重的风险。 

　　301医院风湿科主任医师黄烽教授介绍：“强直性脊柱炎作为一种炎症性疾病，抑制炎症水平很重要，也是目前临床药物治疗的重点。但近些年有研究发现，即使炎症水平得到控制，依然会存在骨结构损伤进一步恶化的情况。如何双管齐下，特别是‘抑制骨结构进展’成为了亟待满足的治疗需求。”

　　全新靶点IL-17A“瞄准”骨结构进展，推动中国强直性脊柱炎生物制剂治疗挺进全新时代

　　强直性脊柱炎从发病到最终骨融合，会经历几大阶段：骨炎-脂肪沉积-骨赘-骨桥-骨融合。“新骨形成”是整个病程进展的病理基础，而IL-17A是个重要的“助推器”。一方面，它是附着点炎发病过程中的关键细胞因子和炎症介质，可进一步促进炎症级联反应；另一方面，它是骨重塑的关键介质，参与新骨形成⁶。因此，抑制IL-17A可阻断炎症通路⁷、缓解疼痛^8,9,10，同时抑制新骨形成来阻止骨结构进一步损伤¹¹。

　　作为目前全球首个且唯一全人源IL-17A抑制剂，多项临床研究证实了可善挺^®的多重获益：

• 快速缓解背痛、晨僵和疲乏症状：MEASURE 2研究结果显示^12,13，患者接受150mg可善挺^®治疗4周，背痛较基线改善39%（安慰剂组：15%），晨僵较基线改善34.4%（安慰剂组：14.8%），疲劳较基线改善28%（安慰剂组：8%）。
• 抑制新骨形成，阻止结构损伤：持续接受可善挺^®治疗，97%基线无骨赘患者和73%基线有骨赘患者2年内无新生骨赘¹⁴，近80%患者脊柱损伤在4年内未出现恶化¹⁵。
• 良好整体安全性和耐受性：IL-17A处于整个炎症通路的下游，且全人源制备工艺降低了不良反应风险。研究显示，经可善挺^®治疗的患者尚无结核易感性增加的报告¹⁶，且目前尚未见经可善挺^®治疗出现乙肝再激活的相关报道¹⁷，5年抗药抗体发生率<1%¹⁸。

　　作为司库奇尤单抗中国III期临床研究负责人，黄烽教授介绍：“司库奇尤单抗的出现无疑为患者提供了一个全新的治疗选择和希望，也让我们对IL-17A这一新靶点在强直性脊柱炎领域的临床表现和潜力充满期待。希望看到更多中国患者能获益于新一代的创新药物！”

　　目前，可善挺^®已在包括欧盟国家和美国在内的多个国家和地区上市，批准用于治疗银屑病、银屑病关节炎及强直性脊柱炎^19,20,21,22，拥有5年持续性疗效和安全性数据支持^23,24,25，惠及全球超过30万患者²⁶。

　　* 银屑病关节炎适应症尚未在中国大陆获批。
** 欲了解更多有关可善挺^®（司库奇尤单抗）产品信息及安全性数据，请前往诺华中国官网（www.novartis.com.cn）搜索“可善挺”或“司库奇尤单抗”获取处方信息。

　　¹中华医学会风湿病学分会. 强直性脊柱炎诊断及治疗指南. 中国风湿病学杂志，2010，14(8):557-560.
²根据国家统计局官网公布的2010年第六次人口普查数据，我国成年人口数约10.5亿。以此数据为基础进行匡算。
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，《中山大学学报：医学科学版》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检索（201501-202002）结果截图
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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