王云;王明悦;夏杨;涂平;李若瑜;李航;

• 1:北京大学第一医院皮肤性病科国家皮肤与免疫疾病临床医学研究中心皮肤病分子诊断北京市重点实验室国家药品监督管理局化妆品质量控制与评价重点实验室
• 2:中国科学院上海生命科学研究院神经科学研究所

摘要(Abstract)：

银屑病是一种慢性炎症性疾病,系统治疗银屑病的传统药物如甲氨蝶呤、维A酸、环孢素等均存在起效慢、疗效有限及不良反应多等缺点。近年来伴随着生物制剂的问世,银屑病治疗效果和安全性得到了显著提升,特别是进入2019年,随着白介素-17抑制剂和白介素-23抑制剂相继在我国应用于银屑病的临床治疗,以其优异的疗效和较高的安全性为银屑病患者带来了前所未有的体验。本文对目前在国内上市并应用于临床治疗银屑病的主要生物制剂作一综述,以期为临床医生提供帮助。

关键词(KeyWords)： 银屑病;生物制剂;治疗

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 王云;王明悦;夏杨;涂平;李若瑜;李航;

参考文献(References)：

• [1]中华医学会皮肤性病学分会银屑病专业委员会.中国银屑病诊疗指南(2018完整版)[J].中华皮肤科杂志，2019，52(10)：667-710.
• [2]SMITH C H,YIU Z Z N,BALE T,et al.British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020:a rapid update[J].Br J Dermatol,2020,183(4):628-637.
• [3]CHIMA M,LEBWOHL M.TNF inhibitors for psoriasis[J].Semin Cutan Med Surg,2018,37(3):134-142.
• [4]VIGUIER M,AUBIN F,DELAPORTE E,et al.Efficacy and safety of tumor necrosis factor inhibitors in acute generalized pustular psoriasis[J].Arch Dermatol,2012,148(12):1423-1425.
• [5]MOCANU M,TOADER M P,REZUS E,et,al.Aspects concerning patient adherence to anti-TNFα therapy in psoriasis:a decade of clinical experience[J].Exp Ther Med,2019,18(6):4987-4992.
• [6]BRODMERKEL C,LI K,GARCET S,et al.Modulation of inflammatory gene transcripts in psoriasis vulgaris:Differences between ustekinumab and etanercept[J].J Allergy Clin Immunol,2019,143(5):1965-1969.
• [7]LEONARDI C L,POWERS J L,MATHESON R T,et al.Etanercept as monotherapy in patients with psoriasis[J].N Engl J Med,2003,349(21):2014-2022.
• [8]PAPP K A,TYRING S,LAHFA M,et al.A global phase Ⅲ randomized controlled trial of etanercept in psoriasis:safety,efficacy,and effect of dose reduction[J].Br J Dermatol,2005,152(6):1304-1312.
• [9]YANG H Z,WANG K,JIN H Z,et al.Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis:a randomized，double-blind,placebo-controlled multicenter trial[J].Chin Med J (Engl),2012,125(11):1845-1851.
• [10]SAURAT J H,STINGL G,DUBERTRET L,et al.Efficacy and Safety Results from the Randomized Controlled Comparative Study of Adalimumab vs.Methotrexate vs.Placebo in Patients with Psoriasis (CHAMPION)[J].Br J Dermatol,2008,158(3):558-566.
• [11]CAI L,GU J,ZHENG J,et al.Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis:results from a phase 3,randomized,placebo-contr-o-lled,double-blind study[J].J Eur Acad Dermatol Vene-reol,2017,31(1):89-95.
• [12]ELEWSKI B E,BAKER C S,CROWLEY J J,et al.Adali-m-umab for nail psoriasis:efficacy and safety over 52 weeks from a phase-3,randomized,placebo-controlled trial[J].J Eur Acad Dermatol Venereol,2019,33(11):2168-2178.
• [13]ELEWSKI B E,OKUN M M,PAPP K,et al.Adalimumab for nail psoriasis:Efficacy and safety from the first 26 weeks of a phase 3,randomized,placebo-controlled trial[J].J Am Acad Dermatol,2018,78(1):90-99.
• [14]DOGRA S,KHULLAR G.Tumor necrosis factor-α antag-onists:Side effects and their management[J].Indian J Dermatol Venereol Leprol,2013,79 Suppl 7:S35-S46.
• [15]BATYCKA-BARAN A,FLAIG M,MOLIN S,et al.Etaner-cept-induced injection site reactions:potential patho-mech-anisms and clinical assessment[J].Expert Opin Drug Saf,2012,11(6):911-921.
• [16]REICH K,NESTLE F O,PAPP K,et al.Infliximab induction and maintenance therapy for moderate-to-severe psoriasis:a phaseⅢ,multicentre,double-blind trial[J].Lancet,2005,366(9494):1367-1374.
• [17]CHARLES P J,SMEENK R J,DE JONG J,et al.Assessment of antibodies to double-stranded DNA induced in rheumatoid arthritis patients following treatment with infliximab,a monoclonal antibody to tumor necrosis factor alpha:findings in open-label and randomized placebo-controlled trials[J].Arthritis Rheum,2000,43(11):2383-2390.
• [18]ERICHSEN C Y,JENSEN P,KOFOED K.Biologic therapies targeting the interleukin (IL)-23/IL-17 immune axis for the treatment of moderate-to-severe plaque psoriasis:a systematic review and meta-analysis[J].J Eur Acad Dermatol Venereol,2019,34(1):30-38.
• [19]THA?I D,BLAUVELT A,REICH K,et al.Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis:CLEAR,a randomized controlled trial[J].J Am Acad Dermatol,2015,73(3):400-409.
• [20]IGARASHI A,KATO T,KATO M,et al.Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis:Long-term results from a phase 2/3 clinical trial[J].J Dermatol,2012,39(3):242-252.
• [21]RESZKE R,SZEPIETOWSKI J C.Secukinumab in the treatment of psoriasis:an update[J].Immunotherapy,2017,9(3):229-238.
• [22]BLAUVELT A,REICH K,TSAI T F,et al.Secukinumab is superior to ustekinumab in clearing skin of subjects with mod-erate-to-severe plaque psoriasis up to 1 year:Results from the CLEAR study[J].J Am Acad Dermatol,2017,76(1):60-69.
• [23]CAI L,ZHANG J Z,YAO X,et al.Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis[J].Chin Med J (Engl),2020,133(22):2665-2673.
• [24]CARRASCOSA J M,DEL-ALCAZAR E.New therapies versus first-generation biologic drugs in psoriasis:a review of adverse events and their management[J].Expert Rev Clin Immunol,2018,14(4):259-273.
• [25]PERANTEAU A J,TURKELTAUB A E,TONG Y,et al.A Review of Ixekizumab,an Anti-Interleukin-17A Monoclonal Antibody,for Moderate-to-Severe Plaque Psoriasis[J].Skin Therapy Lett,2016,21(6):1-6.
• [26]FELDMAN S R,GOMEZ B,MENG X,et al.Secukinumab rapidly improves EQ-5D health status in patients with psoriasis:Pooled analysis from four phase 3 trials[J].J Dermatolog Treat,2021,32(7):709-715.
• [27]WU J J,MEROLA J F,FELDMAN S R,et al.Treatment of Psoriasis with Secukinumab in Challenging Patient Scenarios:A Review of the Available Evidence[J].Dermatol Ther (Heidelb),2020,10(3):351-364.
• [28]SAUNTE D M,MROWIETZ U,PUIG L,et al.Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management[J].Br J Dermatol,2017,177(1):47-62.
• [29]BLAUVELT A,PAPP K A,GRIFFITHS C E,et al.Efficacy and safety of guselkumab,an anti-interleukin-23 monoclonal antibody,compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis:Results from the phase Ⅲ,double-blinded,placebo-and active comparator-controlled VOYAGE 1 trial[J].J Am Acad Derm-atol,2017,76(3):405-417.
• [30]REICH K,PAPP K A,BLAUVELT A,et al.Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2):results from two randomised controlled,phase 3 trials[J].Lancet,2017,390(10091):276-288.
• [31]GORDON K B,STROBER B,LEBWOHL M,et al.Efficacy and Safety of Risankizumab:Results from Two Double-Blind,Placebo-and Ustekinumab-Controlled,Phase 3 Trials in Moderate-to-Severe Plaque Psoriasis[C].San Diego,CA:The American Academy of Dermatology Annual Meeting,2018.
• [32]MENTER A,STROBER B E,KAPLAN D H,et al.Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics[J].J Am Acad Dermatol,2019,80(4):1029-1072.
• [33]MROWIETZ U,KRAGBALLE K,REICH K,et al.Definition of treatment goals for moderate to severe psoriasis:a European consensus[J].Arch Dermatol Res,2011,303(1):1-10.
• [34]NAST A,GISONDI P,ORMEROD A D,et al.European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC[J].J Eur Acad Dermatol Venereol,2015,29(12):2277-2294.
• [35]GISONDI P,ALTOMARE G,AYALA F,et al.Italian guide-lines on the systemic treatments of moderate-to-severe plaque psoriasis[J].J Eur Acad Dermatol Venereol,2017,31(5):774-790.
• [36]NAST A,AMELUNXEN L,AUGUSTIN M,et al.S3 Guideline for the treatment of psoriasis vulgaris,update-Short version part 1-Systemic treatment[J].J Dtsch Dermatol Ges,2018,16(5):645-669.
• [37]AMATORE F,VILLANI A P,TAUBER M,et al.French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults[J].J Eur Acad Dermatol Venereol,2019,33(3):464-483.
• [38]NAST A,SMITH C,SPULS P I,et al.EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris-Part 1:treatment and monitoring recommendations[J].J Eur Acad Dermatol Venereol,2020,34(11):2461-2498.