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诺华Cosentyx(R)5年III期数据展现出持久疗效与安全性

2017-09-13 15:00

- 诺华Cosentyx®5年III期数据展现出持久疗效与安全性,树立银屑病治疗新标杆

- Cosentyx®(secukinumab)(苏金单抗)是第一种也是唯一一种在III期银屑病治疗中展现出5年持续斑块清除作用的人类IL-17A抑制剂1

 - 关键性数据显示,在中重度斑块型银屑病患者中,从Cosentyx治疗第1年到第5年,PASI 90和PASI 100缓解率几乎100%维持1

- III期研究5年数据进一步证实Cosentyx的长期斑块清除作用和安全性1

瑞士巴塞尔2017年9月13日电 /美通社/ -- 诺华今天宣布了III期临床试验的数据,显示出同类首个药品Cosentyx® (secukinumab)(苏金单抗)治疗中重度斑块型银屑病患者可达到较高斑块清除率,且在治疗5年时缓解效果仍可长期维持1。这些数据在瑞典日内瓦举行的第26届欧洲皮肤和性病学会(EADV)大会上首次公开亮相。

Cosentyx能够特异性靶向结合白细胞介素-17A(IL-17A),该因子是银屑病发生过程中非常关键的细胞因子2。IL-17A在斑块型银屑病、银屑病关节炎(PsA)和强直性脊柱炎(AS)的病理发生过程中起了重要作用3-5。由于高达30%的银屑病患者可能患有PsA,因此抑制IL-17A具有重要意义6,7

 “最终数据显示苏金单抗在5年治疗期内具有持久的高疗效和安全性,这对皮肤科医生而言具有重要意义。”加拿大蒙特利尔Innovaderm Research公司的Robert Bissonnette说道。

诺华全球药品开发负责人兼首席医学官Vas Narasimhan说:“5年数据再次证实Cosentyx是渴望达到长期斑块清除的银屑病患者可选的重要治疗药物。Cosentyx是首个、也是唯一一个已获批用于治疗银屑病、银屑病关节炎和强制性脊柱炎的IL-17A抑制剂,自上市以来已有超过10万名患者使用过本药。”

斑块清除是银屑病治疗的目的,银屑病面积与严重性指数(PASI)75、90或100缓解是治疗成功的重要指标8-11。在研究第1年(第52周)至第5年末(第260周)的延长治疗期中,PASI 75/90/100缓解率保持稳定1。在第1年分别有89%和69%的患者达到PASI 75和PASI 90缓解(“观察”分析),并且这样的高缓解率维持到第5年(分别为89%和66%)。此外,44%的银屑病患者在第1年达到斑块完全清除(PASI 100),该比例也维持至第5年(41%)。Cosentyx持续展现出较佳且一致的安全性和低免疫原性1,3

迄今为止,全球已有超过10万例患者使用过Cosentyx处方,涵盖所有适应证12。此外,2017年距离Cosentyx临床试验首例患者首次访视已有10年。

关于Cosentyx和白细胞介素-17A(IL-17A)

Cosentyx已于2015年上市,这是首个也是唯一一个获批用于治疗银屑病、PsA和AS的完全人源IL-17A 抑制剂3。Cosentyx是一种靶向药,能特异性地抑制IL-17A细胞因子。而IL-17A在斑块性银屑病、PsA和AS的病理发生中发挥了重要作用3-5

Cosentyx具有长期斑块清除效果,长达5年的研究数据证实了该药的持久疗效和安全性。Cosentyx给药方便,操作简单,患者只需使用自行给药注射器每月注射一次13。Cosentyx也已获批用于治疗最为难治的斑块型银屑病 -- 掌跖银屑病(手、足部位的银屑病)、头皮银屑病和指甲银屑病3

已有78个国家批准将Cosentyx用于治疗中重度斑块性银屑病,包括欧盟国家、日本、瑞士、澳大利亚、美国和加拿大等。在欧洲,Cosentyx是唯一一种获批作为中重度斑块状银屑病成年患者一线系统性治疗的生物制剂。在美国,Cosentyx也获批用于适合接受系统性治疗或光疗的中重度斑块状银屑病成年患者14

此外,Cosentyx是首个获批用于活动性AS和PsA的IL-17A抑制剂,已在70余个国家获得该适应证批准,包括欧盟国家和美国等。Cosentyx也已在日本获批用于治疗PsA和脓疱型银屑病12

关于Cosentyx 5延伸研究(A2304E11

A2304E1是关键III期SCULPTURE研究的多中心、双盲、开放标签5年延伸研究。该延伸研究的主要目的是评估Cosentyx治疗中重度银屑病患者的长期安全性与耐受性。疗效指标包括达到PASI 75、PASI 90和PASI 100的患者比例。这项长期延伸研究旨在证实Cosentyx的长期疗效与安全性。第1年的162名银屑病患者中,分别有89%和69%的患者达到PASI 75和PASI 90缓解,122名患者的高缓解率维持到第5年(分别为89%和66%)。在SCULPTURE研究中,第12周的PASI 75缓解者被随机分为两组,接受Cosentyx 300mg或150mg的双盲维持治疗,治疗方案为4周固定间隔方案或按需治疗方案。完成了52周SCULPTURE研究的患者可在延伸研究中继续相同剂量、相同方案治疗(N=642)。

关于银屑病

银屑病是一种常见的非传染性自身免疫病,全球银屑病患者数超过1.25亿15。斑块型银屑病是最常见的银屑病类型,表现为突出皮面的红色斑块,其上覆有死亡皮肤细胞堆积而成的银白色鳞屑。

银屑病不仅影响患者外观,而且是一种持续、慢性(长期)疾病,时常令患者感到困扰,即便是日常生活中的小事也有可能受到影响。近30%的银屑病患者可能发生银屑病关节炎(PsA)6。PsA的关节受累会引起疼痛、僵硬等不适症状,部分患者甚至可能出现不可逆的关节损伤6,16。银屑病也经常伴随其他疾病出现,例如糖尿病、心脏病和抑郁等。6

关于诺华免疫与皮科

诺华是全球免疫学与皮肤病领域的领导者。我们致力于改善免疫性疾病患者的生活,尤其关注具有较高未满足医学需求的皮肤病、风湿病、自身炎症性疾病、移植和肝病等专科领域。诺华的领导性品牌Cosentyx®(secukinumab)(苏金单抗)是一种创新性生物药,已在70余个国家获批用于治疗中重度银屑病(PsO)、强直性脊柱炎(AS)和银屑病关节炎(PsA)。其他主要品牌包括用于治疗慢性自发性荨麻疹(CSU)的Xolair®(omalizumab,奥马珠单抗)*、用于移植的Zortress®/Certican®、Myfortic®和用于治疗周期性发热综合征等罕见疾病的Ilaris®(canakinumab,康纳单抗)等。在研产品包括用于肝病的多种药品。

* 在美国,诺华与基因泰克共同推广Xolair并分享运营受益,但不包括美国销售额。

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关于诺华

诺华致力于为患者及社会提供创新医药健康解决方案,以满足其日益变化的健康需求。总部位于瑞士巴塞尔,诺华集团拥有多元化业务组合以最好地满足这些需求,包含创新药、成本节约型非专利药和生物类似药、以及眼科保健产品。诺华在上述各领域均处于全球领先地位。2016年,集团净销售额达485亿美元,集团研发投入约为90亿美元。诺华集团拥有近11.8万名全职员工。诺华的产品在全球155个国家和地区销售。如需更多信息,敬请登录公司网站http://www.novartis.com

关于诺华中国

“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务,致力于提高中国人民的健康水平和生活质量。诺华在中国的业务包括诺华肿瘤、诺华制药、山德士和爱尔康,全国建有三大生产基地,并在上海和江苏设立了两大研发中心。从研发到生产销售,诺华以多元化的业务组合,全面服务中国百姓健康。目前,诺华在中国全资或控股的公司共有六家。诺华在华雇员超过7800人。如需更多信息,敬请登录公司中文网站http://www.novartis.com.cn

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注: 这是最新发布的III期临床试验数据,该药品尚未在中国上市。

参考资料

1.     Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th September 2017.
2.     Zeichner JA and Armstrong A. The role of IL-17 in the pathogenesis and treatment of psoriasis. The Journal of Clinical and Aesthetic Dermatology. 2016;9:S3–S6.
3.     Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124.  Last accessed August 2017.
4.     Nestle et al. Mechanisms of disease psoriasis. New England Journal of Medicine. 2009;361:496-509
5.     Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. British Journal of Dermatology. 2012;167:717-24.
6.     National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed August 2017.
7.     Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. Journal of the American Academy of Dermatology. 2013 Nov 30;69(5):729-35.
8.     European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf.  Last accessed August 2017.
9.     ACTAS Dermo-Sifiliográficas. Spanish Evidence-Based Guidelines on the Treatment of Psoriasis With Biologic Agents. Available at: http://www.actasdermo.org/en/spanish-evidence-based-guidelines-on-treatment/articulo/S1578219013001789/.  Last accessed August 2017.
10.   Canadian Dermatology Association. Canadian Guidelines for the Management of Plaque Psoriasis. Available at: http://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf.  Last accessed August 2017.  
11.   Langley RG et al. The 5‐point Investigator’s Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. Journal of Dermatology Treatment. 2015;26(1):23‐31.
12.   Novartis. Data on file. August 2017.
13.   Lacour JP et al. Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial. Journal of the European Academy of Dermatology and Venereology. 2017;31(5):847-856
14.   Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
15.   International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed August 2017.
16.   Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-441.

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