中国中重度银屑病疾病负担和未满足治疗需求的系统综述

Disease burden and unmet medical needs in Chinese patients with moderate-to-severe psoriasis: a systematic review

目的评价中国中重度银屑病疾病负担(患者数量和疾病特征)和未满足治疗需求(药物治疗现状及不足)。方法对2012年1月1日至2022年8月31日MEDLINE、EMBASE、Web of Science、万方、维普和中国知网数据库中中国中重度银屑病患者高质量真实世界研究证据进行梳理和综述,分析中重度银屑病患者的疾病负担和治疗药物存在的挑战和不足。结果中国中重度银屑病患者占患者的67.0%,经估算约为500万,具有疾病程度重(银屑病面积与严重指数评分为16.3)、皮损面积大(22.1%)、头部皮损患者占比高(63.1%)以及合并代谢综合征患病率高(21.2%)等特点。传统口服治疗药物存在疗效有限和不良反应风险高的挑战;生物制剂治疗12周患者银屑病皮损面积和严重程度指数改善达75%(PASI75)应答率较高(58.7%~91.2%),但治疗52周后中断情况较普遍(15.0%~54.2%),缺乏疗效是主要原因(8.3%~31.4%),其次是经济压力(5.6%~19.0%)和不良反应(2.3%~4.8%)。结论中国中重度银屑病患者数量较为庞大,亟须新的有效、持久、安全且使用方便的药物以满足疾病长期治疗管理的需求。

Objective To evaluate the disease burden(number of patients and characteristics of disease)and unmet medical needs(current status and inadequacy of medical treatment)in Chinese patients with moderate-to-severe psoriasis(msPsO).Methods High-quality real-world evidence on Chinese msPsO patients was sorted and reviewed in the MEDLINE,EMBASE,Web of Science,Wanfang,VIP,and CNKI databases from January 1st,2012 to August 31st,2022.The disease burden as well as challenges and shortcomings of systemic therapeutic drugs were analyzed in Chinese msPsO patients.Results In China,msPsO patients made up a high proportion(67.0%)of psoriasis patients,and the number was estimated to be about 5 million.They were characterized by high severity of disease(the mean psoriasis area and severity index score of 16.3 points),large affected body surface area(22.1%),a high proportion of scalp psoriasis(63.1%),and high prevalence of comorbid metabolic syndrome(21.2%).Current evidence suggested that traditional oral therapeutic drugs were still challenged by limited efficacy and a high risk of adverse reactions,whereas patients showed relatively high rates(58.7%-91.2%)of 75%improvement in psoriasis area and severity index(PASI75)response after 12-week treatment with biological agents;however,discontinuation of biological therapies was common after 52 weeks(15.0%-54.2%),and the main reason was the lack of efficacy(8.3%-31.4%),followed by economic pressures(5.6%-19.0%)and adverse reactions(2.3%-4.8%).Conclusion The number of Chinese msPsO patients is relatively large,and there is an urgent need for new effective,durable,safe,and easily usable drugs to meet the demand for long-term therapeutic management of msPsO.