度普利尤单抗在中国特应性皮炎患者中的疗效和安全性：一项真实世界研究。
Efficacy and Safety of Dupilumab in Chinese Patients With Atopic Dermatitis: A Real-World Study.
作者信息
Zhou Bingjing, Peng Cong, Li Liqiao, Liu Runqiu, Zhu Lei, Chen Xiang, Li Jie
机构信息
Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.
Hunan Key Laboratory of Skin Cancer and Psoriasis, Xiangya Hospital, Central South University, Changsha, China.
出版信息
Front Med (Lausanne). 2022 Mar 23;9:838030. doi: 10.3389/fmed.2022.838030. eCollection 2022.
BACKGROUND
Atopic dermatitis (AD) is a common skin disease, but treatment of this disease has been challenging. Dupilumab is a new biological agent for AD that has been proven to be safe and effective in clinical trials. Although dupilumab was approved for listing in China in June 2020, real-world data about the application of dupilumab in China are lacking. This study aimed to collect and analyze real-world data on dupilumab among Chinese AD patients.
METHODS
Demographic and clinical data for 116 AD patients receiving dupilumab treatment were reviewed. The Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI) of patients were evaluated every 2 weeks from baseline to 16 weeks of treatment. Any adverse events during treatment were recorded.
RESULTS
Among the 116 patients in this study, baseline levels of IgE, eosinophils, and LDH were elevated in 62.79% ( = 86), 45.30% ( = 86), and 54.20% of patients ( = 48), respectively. The SCORAD index and POEM, DLQI, and NRS scores were significantly improved in all patients at 2 weeks ( < 0.0001), 4 weeks ( < 0.01), and 16 weeks ( < 0.001). EASI scores also improved significantly in all patients at 2 weeks ( < 0.01), 4 weeks (> 0.05), and 16 weeks ( < 0.01). However, 11 patients (9.48%) had no response. IgE and LDH levels ( > 0.05), Eosinophil counts ( < 0.01) in blood increased temporarily in the first 4 weeks and then decreased and stabilized during dupilumab treatment. Conjunctivitis was the most common adverse event (2.59%) among the patients. We found that the curative efficacy of dupilumab at 4th weeks was related to the patient's age and course of disease. Nevertheless, there is no relationship between levels of eosinophils, IgE, LDH and the therapeutic efficacy of dupilumab.
CONCLUSION
The real-world data in China showed that dupilumab can effectively treat AD and is well tolerated with a low incidence of adverse events.
背景
特应性皮炎（AD）是一种常见的皮肤病，但该疾病的治疗一直具有挑战性。度普利尤单抗是一种用于治疗AD的新型生物制剂，已在临床试验中被证明是安全有效的。尽管度普利尤单抗于2020年6月在中国获批上市，但缺乏其在中国应用的真实世界数据。本研究旨在收集和分析中国AD患者中关于度普利尤单抗的真实世界数据。
方法
回顾了116例接受度普利尤单抗治疗的AD患者的人口统计学和临床数据。从基线到治疗第16周，每2周评估患者的湿疹面积和严重程度指数（EASI）、特应性皮炎评分（SCORAD）、数字评定量表（NRS）、患者导向性湿疹评估（POEM）以及皮肤病生活质量指数（DLQI）。记录治疗期间的任何不良事件。
结果
在本研究的116例患者中，分别有62.79%（n = 86）、45.30%（n = 86）和54.20%（n = 48）的患者基线时IgE、嗜酸性粒细胞和乳酸脱氢酶（LDH）水平升高。所有患者在治疗2周（P < 0.0001）、4周（P < 0.01）和16周（P < 0.001）时，SCORAD指数以及POEM、DLQI和NRS评分均显著改善。所有患者在治疗2周（P < 0.01）、4周（P > 0.05）和16周（P < 0.01）时EASI评分也显著改善。然而，11例患者（9.48%）无反应。在度普利尤单抗治疗期间，血液中的IgE和LDH水平（P > 0.05）、嗜酸性粒细胞计数（P < 0.01）在前4周暂时升高，然后下降并稳定。结膜炎是患者中最常见的不良事件（2.59%）。我们发现度普利尤单抗在第4周的疗效与患者年龄和病程有关。然而，嗜酸性粒细胞、IgE、LDH水平与度普利尤单抗的治疗效果之间没有关系。
结论
中国的真实世界数据表明，度普利尤单抗可有效治疗AD，耐受性良好，不良事件发生率低。
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