最新数据显示诺华Cosentyx使近80%银屑病患者的皮损接近完全消除

北京2015年3月25日电 /美通社/ -- 诺华日前宣布了来自 CLEAR 研究的结果。该研究表明，Cosentyx™（secukinumab）在消除银屑病患者皮损方面显著优于优特克单抗这一广泛应用的生物制剂¹。详细研究结果在美国旧金山举行的第73届美国皮肤病学会（American Academy of Dermatology，AAD）年会的最新研究会议上进行了披露。Cosentyx（300 mg）是首个也是唯一获准用于治疗中至重度寻常型银屑病成人患者的白细胞介素-17A抑制剂。

在这项 IIIb 期研究中，Cosentyx 达到主要终点优效于优特克单抗，即 Cosentyx 组第16周时银屑病面积与严重性指数（Psoriasis Area Severity Index，PASI）改善90%或者说皮损完全消除或接近完全消除²的患者比例高于优特克单抗组（79.0% vs. 57.6%，P<0.0001）¹。PASI 90被欧洲药品管理局认为是重要的治疗成功指标²，并且对患者而言是最佳的治疗目标³。此外，Cosentyx 组第16周时皮损完全消除（PASI 100）的患者比例也显著高于优特克单抗组（44.3% vs. 28.4%，P<0.0001）¹。

诺华制药全球研发负责人 Vasant Narasimhan 表示：“来自 CLEAR 研究的结果进一步表明 Cosentyx 是如何改变银屑病治疗方式和帮助患者完全消除皮损的。随着 Cosentyx 目前在全球许多国家获得批准，我们将尽最大努力帮助银屑病患者大幅提高整体生活质量。”

此外，Cosentyx 在截至第16周的所有研究时间点均显示出起效快和疗效更佳的特点，早在第4周时 Cosentyx 组就有50%的患者达到PASI 75，而优特克单抗组仅有20.6%的患者达到 PASI 75（P<0.0001）¹。Cosentyx 的安全性与优特克单抗相当，并且与既往 III 期 Cosentyx 临床试验报告的安全性结果一致^1,4-6。

Cosentyx 尚未在中国获得批准。

参考资料

1. Thaci D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 16 week results from the CLEAR study. American Academy of Dermatology 73^rd Annual Meeitng. San Francisco, California. 20^th March.

2. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Guidelines on clinical investigation of medicinal products indicated for the treatment of psoriasis. 2004. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf Accessed February 9, 2015.

3. Mrowietz, U. Implementing treatment goals for successful long-term management of psoriasis. Journal of the European Academy of Dermatology and Venereology, 26: 12–20. doi: 10.1111/j.1468-3083.2011.04411.x

4. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.

5. Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Administration by Pre-filled Syringe: Efficacy, Safety, and Usability Results from a Randomized Controlled Trial in Psoriasis (FEATURE). Br J Dermatol. 2014. Dec 11; 172(2): 484–493. doi: 10.1111/bjd.13348

6. Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014. Sep 22; doi: 10.1111/jdv.12751

7. Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.

8. Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.

9. Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.

10. Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.

11.Krueger J, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130(1):145-154.

12.Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J Dermatol. 2009;160(2):319-24.

13. Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.

14. Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.

15. Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.

16. International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. “About Psoriasis.”http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed February 2014 .

17. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003–2011. JAMA Dermatol. 2013;149(10):1180-1185.