司库奇尤单抗治疗成人中重度斑块状银屑病临床疗效及安全性评价  

Evaluation on clinical efficacy and safety of secukinumab in treatment of moderate to severe plaque psoriasis in adults

作　　者：刘子毓 周明伟[1] 李香兰[1] 陈凤[1] 朱明姬[1] 姜日花[1] LIU Ziyu;ZHOU Mingwei;LI Xianglan;CHEN Feng;ZHU Mingji;JIANG Rihua(Department of Dermatology,China-Japan Union Hospital,Jilin University,Changchun 130033,China)

机构地区：[1]吉林大学中日联谊医院皮肤科,吉林长春130033

出　　处：《吉林大学学报（医学版）》2024年第6期1683-1690,共8页Journal of Jilin University：Medicine Edition

基　　金：吉林省科技厅自然科学基金项目(YDZJ202301ZYTS506)。

摘　　要：目的:评价司库奇尤单抗治疗成人中重度斑块状银屑病的临床疗效和安全性。方法:收集183例接受司库奇尤单抗治疗的成人中重度斑块状银屑病患者的临床资料,第0、1、2、3和4周每周皮下注射司库奇尤单抗1次,其后每4周注射1次,每次300 mg,随访52周。计算银屑病患者的银屑病面积及严重指数(PASI)、体表受累面积(BSA)、基线研究者整体评估(IGA)及平均皮肤病生活质量指数(DLQI)评分,以银屑病患者是否达到PASI 100,分为痊愈组和非痊愈组,评价司库奇尤单抗治疗中重度斑块状银屑病的临床疗效和安全性,并分析其影响因素。结果:与治疗0周时比较,司库奇尤单抗治疗第4、12、24和52周患者PASI、BAS、IGA及DLQI评分均明显降低(P<0.05)。司库奇尤单抗治疗后PASI 75、PASI 90和PASI 100患者百分率于第4周分别为95.6%、84.2%和47.5%,第12周分别为97.3%、95.6%和78.7%,第24周分别为97.8%、96.7%和84.2%,第52周分别为98.4%、97.8%和83.6%;BSA≤1%患者百分率于第4、12、24和52周分别为80.9%、94.5%、95.6%及94.0%;IGA 0/1患者百分率于第4、12、24和52周分别为86.3%、97.3%、96.7%及95.6%;DLQI 0/1患者百分率于第4、12、24和52周分别为76.6%、89.1%、92.9%及91.8%。司库奇尤单抗治疗第4周,2组患者年龄、体质量指数(BMI)、病程、基线PASI评分和既往生物制剂治疗史患者百分率比较差异均有统计学意义(P<0.05);司库奇尤单抗治疗第24周,2组患者年龄和BMI比较差异有统计学意义(P<0.05)。司库奇尤单抗治疗第4周,BMI≥25 kg·m^(-2)、病程≥10年、基线PASI评分≥10和有既往生物制剂治疗史是影响患者痊愈的危险因素(P<0.05);司库奇尤单抗治疗第24周,年龄≥40岁是影响患者痊愈的危险因素(P<0.05)。183例银屑病患者在治疗期间共44例患者报告49次不良反应,出现不良反应患者百分率为24.0%,无严重不良事件和致死性不良反应发生。不良反应包括上呼吸道�Objective:To evaluate the clinical efficacy and safety of secukinumab in the treatment of moderate to severe the adults with plaque psoriasis.Methods:The clinical data from 183 adult patients with moderate to severe plaque psoriasis treated with secukinumab were collected.The patients received subcutaneous injections of secukinumab once a week at weeks 0,1,2,3,and 4,followed by an injection every 4 weeks,with each dose of 300 mg.The follow-up period was 52 weeks.The psoriasis area and severity index(PASI),body surface area(BSA),investigator global assessment(IGA),and dermatology life quality index(DLQI)scores of the patients with psoriasis were caculated.The clinical efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis were evaluated,and the influencing factors were analyzed.Results:Compared with week 0,the PASI、BSA、IGA and DLQI scores of the patients were significantly decreased at weeks 4,12,24,and 52 of secukinumab treatment(P<0.05).After treated with secukinumab,the percentages of the patients achieving PASI 75,PASI 90,and PASI 100 at week 4 were 95.6%,84.2%,and 47.5%,respectively;at week 12,they were 97.3%,95.6%,and 78.7%,respectively;at week 24,they were 97.8%,96.7%,and 84.2%,respectively;and at week 52,they were 98.4%,97.8%,and 83.6%,respectively.The percentages of the patients with BSA≤1%at weeks 4,12,24,and 52 were 80.9%,94.5%,95.6%,and 94.0%,respectively.The percentages of the patients with IGA score of 0/1 at week 4,12,24,and 52 were 86.3%,97.3%,96.7%,and 95.6%,respectively.The percentages of the patients with DLQI score of 0/1 at weeks 4,12,24,and 52 were 76.6%,89.1%,92.9%,and 91.8%,respectively.At week 4 of secukinumab treatment,there were significant differences in age,body mass index(BMI),disease duration,baseline PASI score,and history of previous biologic treatment between the patients in two groups(P<0.05).At week 24 of secukinumab treatment,there were significant differences in age and BMI between the patients in two groups(P<0.05).At week 4,BMI≥25

关 键 词：银屑病 司库奇尤单抗 临床疗效 安全性评价 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]