中华皮肤科杂志 ›› 2023, Vol. 56 ›› Issue (6): 504-511.doi: 10.35541/cjd.20220938

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[开放获取]   奥马珠单抗治疗对抗组胺药反应不佳的慢性荨麻疹患者单中心回顾性研究

李丽俏    彭聪    陈翔    李捷   

  1. 中南大学湘雅医院皮肤科  皮肤肿瘤与银屑病重点实验室  国家老年疾病临床医学研究中心（湘雅医院），长沙  410008
  • 收稿日期:2022-12-30 修回日期:2023-04-01 发布日期:2023-06-05
  • 通讯作者: 李捷 E-mail:xylijie@csu.edu.cn
  • 基金资助:
    国家自然科学基金（82173424、81974476）

Efficacy of omalizumab in the treatment of chronic urticaria patients with poor response to antihistamines: a single-center retrospective study

Li Liqiao, Peng Cong, Chen Xiang, Li Jie   

  1. Department of Dermatology, Xiangya Hospital, Central South University, Key Laboratory of Skin Tumor and Psoriasis, National Clinical Medical Research Center for Geriatric Diseases （Xiangya Hospital）, Changsha 410008, China
  • Received:2022-12-30 Revised:2023-04-01 Published:2023-06-05
  • Contact: Li Jie E-mail:xylijie@csu.edu.cn
  • Supported by:
    National Natural Science Foundation of China（82173424、81974476）

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摘要： 【摘要】 目的 了解奥马珠单抗治疗H1抗组胺药控制不佳的慢性荨麻疹（CU）患者的疗效及安全性。方法 纳入中南大学湘雅医院皮肤科2020年6月至2021年6月使用H1抗组胺药疗效不佳并接受奥马珠单抗治疗的CU患者，通过7 d荨麻疹活动度评分（UAS7）、荨麻疹控制评分（UCT）评估治疗后4、12、24周的疗效。采用t检验、卡方检验、Pearson相关分析等分析临床特征与疗效的关系。结果 共121例符合入排标准且数据资料相对完整的CU患者纳入本研究，男54例（44.63%）、女67例（55.37%），年龄13 ~ 70（39.88 ± 14.36）岁；88例为慢性自发性荨麻疹（72.73%），10例（8.26%）为慢性诱导性荨麻疹，23例为慢性自发性荨麻疹合并慢性诱导性荨麻疹（19.01%）。奥马珠单抗治疗4周时有效率为50.86%（59/116），完全应答率为25.86%（30/116）；12周时有效率为78.26%（54/69），完全应答率为34.78%（24/69）；24周时有效率为64.71%（22/34），完全应答率为23.53%（8/34）。治疗4周时，基线血清总IgE < 40 IU/ml的CU患者（26例）治疗有效率（30.77%）显著低于血清总IgE ≥ 40 IU/ml者（61例）（65.57%，χ2 = 8.93，P = 0.004）。相关性分析显示，治疗年龄、发病年龄、合并过敏性疾病、伴随症状、基线红细胞沉降率、基线C反应蛋白水平均与UCT评分显著相关（均P < 0.05），而病程、临床类型、血清总IgE水平、外周血细胞计数、皮肤病生活质量指数、UAS7评分等与UCT评分无显著相关性。121例CU患者中，8例（6.61%）报道了轻中度不良反应。结论 奥马珠单抗可有效改善H1抗组胺药控制不佳CU患者的临床症状和体征，且耐受性良好；对于无合并过敏性鼻炎等过敏性共病、无血管性水肿等伴随症状、红细胞沉降率及C反应蛋白水平相对较低的患者在奥马珠单抗治疗中可能获益更多。

关键词: 荨麻疹, 生物制剂, 治疗结果, 慢性自发性荨麻疹, 奥马珠单抗

Abstract: 【Abstract】 Objective To investigate the efficacy and safety of omalizumab in the treatment of chronic urticaria （CU） patients with poor response to H1 antihistamines. Methods CU patients, who showed poor response to H1 antihistamines and received omalizumab treatment, were collected from the Department of Dermatology, Xiangya Hospital, Central South University from June 2020 to June 2021. The efficacy of omalizumab was evaluated by using the 7-day urticaria activity score （UAS7） and urticaria control test （UCT） score at weeks 4, 12 and 24 after the start of treatment. The t-test, chi-square test, and Pearson correlation analysis were used to analyze the relationship between the clinical characteristics and efficacy. Results A total of 121 CU patients who met the inclusion criteria and had relatively complete medical records were included in this study, including 54 males （44.63%） and 67 females （55.37%）, and their ages ranged from 13 to 70 years （39.88 ± 14.36 years）; 88 patients were diagnosed with chronic spontaneous urticaria （72.73%）, 10 with chronic inducible urticaria （8.26%）, and 23 with chronic spontaneous urticaria accompanied by chronic inducible urticaria （19.01%）. At week 4 after the start of omalizumab treatment, the response rate was 50.86% （59/116）, and the complete response rate was 25.86% （30/116）; at week 12, the response rate was 78.26% （54/69）, and the complete response rate was 34.78% （24/69）; at week 24, the response rate was 64.71% （22/34）, and the complete response rate was 23.53% （8/34）. At week 4, CU patients with baseline serum total IgE levels of < 40 IU/ml had a lower response rate （26 cases, 30.77%） than those with baseline serum total IgE levels of ≥ 40 IU/ml （61 cases, 65.57%; χ2 = 8.93, P = 0.004）. Correlation analysis showed that the age at treatment, age at onset, allergic diseases, concomitant symptoms, baseline erythrocyte sedimentation rates, and baseline C-reactive protein levels were significantly correlated with the UCT scores （all P < 0.05）, while the course of disease, clinical types, serum total IgE levels, peripheral blood counts, dermatology life quality index scores, and UAS7 scores were not significantly correlated with the UCT scores. Among the 121 CU patients, 8 （6.61%） reported mild to moderate adverse reactions. Conclusion Omalizumab could effectively improve clinical symptoms and signs of CU patients with poor response to H1 antihistamines, and was well tolerated;omalizumab treatment may be more beneficial to patients without allergic comorbidities such as allergic rhinitis, without concomitant symptoms such as angioedema, and with lower erythrocyte sedimentation rates and C-reactive protein levels.

Key words: Urticaria, Biological agents, Treatment outcome, Chronic spontaneous urticaria, Omalizumab

引用本文

李丽俏 彭聪 陈翔 李捷. [开放获取]   奥马珠单抗治疗对抗组胺药反应不佳的慢性荨麻疹患者单中心回顾性研究[J]. 中华皮肤科杂志, 2023,56(6):504-511. doi:10.35541/cjd.20220938

Li Liqiao, Peng Cong, Chen Xiang, Li Jie. Efficacy of omalizumab in the treatment of chronic urticaria patients with poor response to antihistamines: a single-center retrospective study[J]. Chinese Journal of Dermatology, 2023, 56(6): 504-511.doi:10.35541/cjd.20220938