中国银屑病生物制剂及小分子药物治疗指南(2024版)

Guidelines for the treatment of psoriasis with biologics and small-molecule drugs in China(2024)

银屑病的治疗已经进入靶向治疗时代,生物制剂和小分子药物的应用显著改善了患者的生活质量,特别是在中重度、难治性及特殊类型银屑病治疗方面发挥了积极的作用。我国批准上市并已用于治疗银屑病的生物制剂包括肿瘤坏死因子α抑制剂、白细胞介素12/23抑制剂、白细胞介素23抑制剂、白细胞介素17A抑制剂及白细胞介素36抑制剂五大类9种制剂;小分子药物包括抑制炎症细胞因子通路中磷酸二酯酶4、Janus激酶(包括酪氨酸激酶2)等不同环节共两类4种药物。如何合理、有效、安全地使用生物制剂及小分子药物已经成为临床工作中备受关注的问题。为此,我国银屑病诊疗及相关领域专家依据国内外研究数据和临床经验,结合中国银屑病患者的特点,在深入讨论的基础上制订本指南,从生物制剂和小分子药物的应用原则与方法、疗效与安全性、患者的筛查与监测、常见问题与对策以及特殊人群应用的注意事项等方面,为临床医生提供具体的指导意见。

The treatment of psoriasis has entered an era of targeted therapy,and the application of biologics and small-molecule drugs has markedly improved the quality of life of patients,especially in the treatment of moderate to severe,refractory,and special types of psoriasis.In China,biologics that have been approved for marketing and used in the treatment of psoriasis include 9 agents belonging to 5 major categories,namely tumor necrosis factor-αinhibitors,interleukin-12/23 inhibitors,interleukin-23 inhibitors,interleukin-17A inhibitors,and interleukin-36 inhibitors;small-molecule drugs include 4 drugs belonging to 2 categories that inhibit different steps in the inflammatory cytokine pathways,namely phosphodiesterase 4 and Janus kinases(including tyrosine kinase 2).How to use biologics and small-molecule drugs in a rational,effective and safe way has become an issue of great concern in clinical practice.To this end,experts in the field of diagnosis and treatment of psoriasis and related fields in China developed this guideline based on Chinese and international research data,clinical experience,as well as characteristics of Chinese patients with psoriasis after in-depth discussions.This guideline provides specific guidance for clinicians in terms of application principles and methods of major biologics and small-molecule drugs,efficacy and safety profiles,patient screening and monitoring,common problems and solutions,as well as considerations for their application in special populations.