基于真实世界数据的司库奇尤单抗治疗寻常型银屑病的疗效与安全性分析
广东省佛山市顺德区慢性病防治中心
目的 依托本地临床真实诊疗数据,分析司库奇尤单抗用于中重度斑块状银屑病人群的实际临床获益与用药安全特征。方法 回顾性纳入71例于2021年12月至2024年7月就诊于顺德慢性病防治中心、符合中重度斑块状银屑病诊断标准的成年患者,全部予以300 mg规格司库奇尤单抗注射液皮下注射规范干预,完整随访周期不少于16周。以银屑病面积与严重程度指数(PASI)、皮肤病生活质量指数(DLQI)的动态变化作为疗效判定标准,同步统计随访期间各类不良事件发生情况以完成安全性评估。结果 全部受试者完成16周规范干预后,PASI、DLQI评分较基线水平均出现大幅降低(P<0.001);治疗至第16周时,患者PASI75、PASI90、PASI100达标比例依次为100.00%、88.73%、67.61%;16周时DLQI 0/1(皮损不影响日常生活)达标率达83.10%;本次随访队列无受试者因不耐受不良反应或治疗效果不足中断用药。结论 真实临床场景下,300 mg司库奇尤单抗对中重度斑块型银屑病具备突出治疗效果,皮损清除达标率整体可观,用药安全表现良好;患者体重指数(BMI)会对该药物临床应答水平产生明显影响。
Objective To explore the clinical efficacy and safety profile of secukinumab among patients with moderateto-severe plaque psoriasis based on local real-world clinical data. Methods A total of 71 adult patients diagnosed with moderate-to-severe plaque psoriasis and treated at the Shunde Chronic Disease Prevention and Treatment Center from December 2021 to July 2024 were retrospectively included. All participants received standardized subcutaneous injection of 300 mg of secukinumab with a follow-up period of no less than 16 weeks. Dynamic variations in PASI and DLQI scores were adopted to judge therapeutic effects, and all adverse events recorded during follow-up were summarized for safety assessment. Results Dramatic declines in PASI and DLQI scores were observed in all subjects after 16-week intervention(P<0.001). At week 16, the proportions of patients achieving PASI75, PASI90 and PASI100 were 100.00%, 88.73% and 67.61%, separately. The proportion of patients reaching DLQI 0/1(no interference of skin lesions on daily life) reached 83.10% at week 16. None of the participants suspended treatment owing to adverse reactions or unsatisfactory therapeutic effects. Conclusion Secukinumab 300 mg delivers remarkable clinical benefits for patients with moderate-severe plaque psoriasis under routine clinical conditions, with high rates of complete or partial lesion clearance and favorable safety profile. Body mass index(BMI) is an independent factor interfering with the therapeutic response of secukinumab.
引用本文
按标准格式复制,或导出到文献管理软件参考文献
共 14 条- [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]中华医学会皮肤性病学分会.中国银屑病生物治疗专家共识(2021)[J].中华皮肤科杂志,2021,54(12):1033-1046.
- [3]Cai L,Zhang JZ,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.
- [4]Huang H,Cai ML,Hong XJ,et al. Real-world data on the use of secukinumab as treatment for moderate-to-severe psoriasis in Chinese patients[J].Eur J Dermatol,2020,30(5):554-560.
- [5]Ger TY,Huang YH,Hui RC,et al. Effectiveness and safety of secukinumab for psoriasis in real-life practice:analysis of subgroups stratified by prior biologic failure or reimbursement[J]. Ther Adv Chronic Dis,2019,10:2040622319843756.
- [6]Bruin G,Loesche C,Nyirady J,et al. Population pharmacokinetic modeling of secukinumab in patients with moderate to severe psoriasis[J]. J Clin Pharmacol,2017,57(7):876-885.
- [7]Ortiz-Salvador JM,Saneleuterio-Temporal M,Magdaleno-Tapial J,et al. A prospective multicenter study assessing effectiveness and safety of secukinumab in a real-life setting in 158 patients[J]. J Am Acad Dermatol,2019,81(2):427-432.
- [8]Notario J,Deza G,Vilarrasa E,et al. Treatment of patients with plaque psoriasis with secukinumab in a real-life setting:A 52-week,multicenter,retrospective study in Spain[J]. J Dermatolog Treat,2019,30(5):424-429.
- [9]Szepietowski J,Rich P,Loeffler J,et al. Secukinumab300 mg shows superior efficacy across subject body weight groups:pooled analysis of phase 3 ERASURE and FIXTURE trials[J]. J Am Acad Dermatol,2015,72(5):AB248.
- [10]袁瑾,黄悦,周昆丽,等.司库奇尤单抗治疗中重度斑块状银屑病疗效及安全性的真实世界研究[J].中国皮肤性病学杂志,2023,37(10):1133-1137.
- [11]Rompoti N,Katsimbri P,Kokkalis G,et al. Real life data from the use of secukinumab in the treatment of moderate-to-severe psoriasis,including scalp and palmoplantar psoriasis:a 104-week clinical study[J].Dermatol Ther,2019,32:e13006.
- [12]Dogan S,Atakan N. Multiple lentigines confined to psoriatic plaques induced by biologic agents in psoriasis therapy:a case and review of the literature[J]. Cutan Ocul Toxicol,2015,34(3):262-264.
- [13]Maria PS,Valenzuela F,Morales C,et al. Lentiginous eruption in resolving psoriasis plaques during treatment with ixekizumab:a case report and review of the literature[J]. Dermatol Rep,2017,9(2):7079.
- [14]Lee B,Reynolds KA,Pithadia DJ,et al. Appearance of lentigines in psoriasis patient treated with guselkumab[J]. Dermatol Online J,2019,25(1):13.
| 文章编号 | 2026-06-037(期号内编号) |
|---|---|
| 栏目 | 临床药物与手术治疗 |
| 作者 | 赵伟峰;莫柳娟;戴县娇;钟彩梅;周洁仙 |
| 作者单位 | 广东省佛山市顺德区慢性病防治中心 |
| 基金项目 | 佛山市科学技术局(2220001005149) |
| 中图分类号 | R758.63 |
| 卷期页码 | 2026, 2(06): 145-148 |
| 发布时间 | 2026-09-15 |
| 出版时间 | 2026-09-15 |
| 引用信息 | [1]赵伟峰,莫柳娟,戴县娇,等.基于真实世界数据的司库奇尤单抗治疗寻常型银屑病的疗效与安全性分析[J].疾病预防与控制,2026,2(06):145-148. |
| 全文地址 | 在知网查看该文(kns.cnki.net) |
| 数据抓取时间 | 2026-10-15T03:31:19 |