中华皮肤科杂志 ›› 2022, Vol. 55 ›› Issue (4): 295-298.doi: 10.35541/cjd.20210736

• 论著 • 上一篇    下一篇

【开放获取】度普利尤单抗治疗特应性皮炎的疗效及安全性分析

刘擘    宋晓婷    李若瑜    赵作涛    

  1. 北京大学第一医院皮肤性病科  皮肤病分子诊断北京市重点实验室  国家皮肤与免疫疾病临床医学研究中心  国家药品监督管理局化妆品质量控制与评价重点实验室，北京  100034
  • 收稿日期:2021-10-09 修回日期:2022-02-13 发布日期:2022-04-01
  • 通讯作者: 赵作涛 E-mail:zhaozuotaotao@163.com

Clinical efficacy and safety of dupilumab in the treatment of atopic dermatitis

Liu Bo, Song Xiaoting, Li Ruoyu, Zhao Zuotao   

  1. Department of Dermatology and Venereology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Diseases, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing 100034, China
  • Received:2021-10-09 Revised:2022-02-13 Published:2022-04-01
  • Contact: Zhao Zuotao E-mail:zhaozuotaotao@163.com

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摘要： 【摘要】 目的 评价度普利尤单抗治疗特应性皮炎（AD）的有效性和安全性。方法 采用回顾性研究方法，纳入2020年6月1日至2021年9月1日在北京大学第一医院皮肤科门诊外用药物控制不佳、规范使用度普利尤单抗注射治疗满16周的AD患者。收集患者基本信息以及治疗开始前、治疗第2、4、8、12、16周研究者整体评估（IGA）评分、湿疹面积及严重程度指数（EASI）评分、瘙痒数字评价量表（NRS）评分、皮肤病生活质量指数（DLQI）评分以及源自患者的湿疹评价（POEM）评分。记录治疗过程中出现的不良反应。采用Wilcoxon秩和检验对全部患者结束随访时各项评分和治疗前进行比较。结果 共纳入57例AD患者，均完成16周的注射药物治疗和随访观察。第16周时 ，患者自身IGA评分由基线4.0（4.0，5.0）分降至1.0（1.0，1.0）分（Z = 6.65，P < 0.001），EASI评分由30.0（17.2，36.0）分降至4.0（1.6，7.3）分（Z = 6.57，P < 0.001），瘙痒NRS评分由9.0（7.0，10.0）分降至1.0（0.0，1.0）分（Z = 6.59，P < 0.001），DLQI评分由15.0（11.5，20.5）分降至3.0（1.0，4.0）分（Z = 6.57，P < 0.001），POEM评分由19.0（15.5，23.0）分降至4.0（2.0，4.0）分（Z = 6.57，P < 0.001），差异均有统计学意义。5种评分16周内均呈持续下降趋势。仅2例患者出现结膜炎，无明显严重不良反应。结论 度普利尤单抗治疗AD疗效明显，且具有较好的安全性。

关键词: 皮炎, 特应性, 白细胞介素4, 白细胞介素13, 生物制剂, 治疗, 药物毒性, 度普利尤单抗

Abstract: 【Abstract】 Objective To evaluate efficacy and safety of dupilumab in the treatment of atopic dermatitis （AD）. Methods A retrospective study was conducted among patients with AD who showed poor response to topical agents and then received standardized injections of dupilumab for 16 weeks in Department of Dermatology, Peking University First Hospital from June 1, 2020 to September 1, 2021. Basic information on the patients was collected, so were the Investigator′s Global Assessment （IGA） , Eczema Area and Severity Index （EASI） , Itch Numeric Rating Scale （NRS） , Dermatology Life Quality Index （DLQI） , and Patient-Oriented Eczema Measure （POEM） scores recorded before and at weeks 2, 4, 8, 12, and 16 during treatment. Adverse reactions were recorded during treatment. Wilcoxon rank sum test was used to compare the scores of all patients at the end of follow-up with those before treatment. Results A total of 57 patients were enrolled in the study, and all completed 16-week injections and follow-up. At week 16, the patients′ IGA, EASI, NRS, DLQI, and POEM scores significantly decreased from 4.0 （4.0, 5.0）, 30.0 （17.2, 36.0）, 9.0 （7.0, 10.0）, 15.0 （11.5, 20.5）, and 19.0 （15.5, 23.0） points respectively at baseline to 1.0 （1.0, 1.0）, 4.0 （1.6, 7.3）, 1.0 （0.0, 1.0）, 3.0 （1.0, 4.0）, and 4.0 （2.0, 4.0） points respectively （Z = 6.65, 6.57, 6.59, 6.57, and 6.57 respectively, all P < 0.001）. All the 5 scale scores showed a continuous downward trend within 16 weeks after the start of dupilumab treatment. During the follow-up period, no serious adverse reaction was observed, and only two patients developed conjunctivitis. Conclusion Dupilumab shows marked efficacy in the treatment of AD, with favorable safety.

Key words: Dermatitis, atopic, Interleukin-4, Interleukin-13, Biological agents, Therapy, Drug toxicity, Dupilumab