中国麻风皮肤病杂志 ›› 2024, Vol. 40 ›› Issue (1): 21-25.doi: 10.12144/zgmfskin202401021

• 论著 • 上一篇    下一篇

度普利尤单抗治疗大疱性类天疱疮16周疗效和安全性分析

周昱希1,李佶姝1,王金秋2,李晓红2,冯尘尘2,周兴丽1,李薇1   

  1. 1四川大学华西医院皮肤科，四川成都，610041；2四川大学华西医院门诊部，四川成都，610041
  • 出版日期:2024-01-15 发布日期:2023-12-25

Efficacy and safety of dupilumab in the treatment of bullous pemphigoid for 16 weeks: a retrospective study

ZHOU Yuxi1, LI Jishu1, WANG Jinqiu2, LI Xiaohong2, FENG Chenchen2, ZHOU Xingli1, LI Wei1   

  1. 1 Department of Dermatology & Venerology, Rare Diseases Center, West China Hospital, Sichuan University, Chengdu 610041, China; 2 Outpatient Department, West China Hospital, Sichuan University, Chengdu 610041, China
  • Online:2024-01-15 Published:2023-12-25

PDF (PC)

41

摘要： 目的：评价度普利尤单抗治疗大疱性类天疱疮(BP)的疗效与安全性。方法：回顾性分析2021年2月至2023年2月四川大学华西医院皮肤科应用度普利尤单抗治疗的BP患者临床、实验室资料及新冠感染情况，选择大疱性类天疱疮疾病面积指数评分(BPDAI)和瘙痒数字评分量表(NRS)评价BP患者的皮损严重程度和瘙痒情况，Karnofsky 评分评价患者功能状态，常见不良事件评价标准(CTCAE)5.0 版评估发生的不良反应。结果：共纳入16例患者，随访16周后，8例(50%)达到疾病控制，6例(37.5%)达到疾病完全缓解，2例(12.5%)因疗效不佳或严重不良反应停用。 BPDAI评分(8.37±9.45)和NRS评分(3.2±1.05)较治疗前(38.38±21.90；8.8±0.65)均明显下降，Karnofsky评分由基线(44.67±23.01)升高至(79.33±19.82)，差异均有统计学意义(均P<0.05)。16例患者中3例（18.7%）感染新冠，对症或局部治疗后好转；其余病情稳定。1例(6.25%)出现呼吸衰竭、粒细胞下降，1例(6.25%)出现全身大汗，2例(12.5%)出现局部不良反应，未报道其他不良事件。结论：新冠感染疫情对于本次纳入的BP患者疾病管理未造成明显影响，度普利尤单抗治疗BP疗效好且安全性较高。

关键词: 度普利尤单抗, 大疱性类天疱疮, 临床疗效, 安全性

Abstract: Objective: To evaluate efficacy and safety of dupilumab in the treatment of bullous pemphigoid (BP). Methods: A retrospective study was conducted among 16 patients with BP treated by dupilumab from February, 2021 to February, 2023. The clinical, laboratory and COVID-19 infection date were analyzed. The severity of skin lesions and itching were evaluated by bullous pemphigoid disease area index (BPDAI) and numerical rating scale (NRS) respectively. Karnofsky score was used to evaluate the functional status of BP patients. Common Terminology Criteria for Adverse Events (CTCAE) was used for adverse events evaluation. Results: A total of 16 BP patients were included in this study. At week 16, 8 (50%) cases achieved disease control, 6 (37.5%) cases achieved complete remission, 2 (12.5%) cases were discontinued due to poor efficacy or adverse reactions. The average score of BPDAI and NRS decreased from 38.38±21.90 and 8.8±0.65 to 8.37±9.45 and 3.2±1.05, with significant differences (Ps＜0.05). Karnofsky score increased from 44.67±23.01 to 79.33±19.82 (P＜0.05). Among the 16 patients, 3 (18.7%) tested positive for COVID-19 and improved after symptomatic or topical treatment, while the rest remained stable. Respiratory failure and granulocytopenia occurred in 1 case (6.25%), systemic sweating in 1 case (6.25%), and local adverse reactions in 2 cases (12.5%). No other adverse events were found. Conclusion: The COVID-19 epidemic has no significant impact on the disease management of BP patients enrolled in this study. Dupilumab is an effective and safe treatment for bullous pemphigoid patients.

Key words: upilumab, bullous pemphigoid, clinical efficacy, safety