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皮肤科诊所慢性自发性荨麻疹患者使用奥马珠单抗的10年真实世界分析

A 10-Year Real-World Analysis of Omalizumab Use in Chronic Spontaneous Urticaria Patients at a Dermatology Clinic.

作者信息

Cetinkaya Pinar Ozdemir, Arslan Zulkuf, Dirliktutan Berkay, Karaosmanoglu Nermin

机构信息

Department of Dermatology and Venereology, University of Health Sciences Türkiye, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Türkiye.

Department of Dermatology and Venereology, Ankara Training and Research Hospital, Ankara, Türkiye.

出版信息

Sisli Etfal Hastan Tip Bul. 2025 Feb 7;59(2):194-199. doi: 10.14744/SEMB.2025.79059. eCollection 2025.

Abstract

OBJECTIVES

Chronic spontaneous urticaria (CSU) is characterized by recurrent wheals and/or angioedema lasting more than 6 weeks. The disease is marked by unpredictable, severe itching attacks, significantly impacting patients' quality of life and often prompting them to seek medical treatment. This study aimed to evaluate the efficacy of omalizumab in patients with CSU and identify the factors that determine its effectiveness.

METHODS

This retrospective descriptive study analyzed registered data of 159 patients with CSU who received omalizumab at a tertiary dermatology clinic. The study recorded patient demographics, allergic conditions, omalizumab dosage, treatment response time, efficacy, duration of use, and additional medications. It also included assessments of total IgE levels.

RESULTS

Of 159 patients with CSU, 112 (70.4%) were females, and 42 (29.6%) were males with a median age of 43 years (IQR = 20). Among the patients, 156 (98.1%) received a 300 mg dose of omalizumab, while 3 (1.9%) received 450 mg. Additionally, 41 (25.8%) required antihistamines and corticosteroids in addition to omalizumab, while 118 (74.2%) were treated with omalizumab alone. The median response time was 3 months, with 116 (73%) showing complete responses and 39 (24.5%) showing partial responses. Four patients (2.5%) showed no response. When patients were categorized into two groups-those receiving only omalizumab and those on combination therapy, the median response time to omalizumab was statistically significantly longer in the combination therapy group (mean=2.53±0.76, median=3, IQR=1 vs. mean=3.49±1.63, median=3, IQR=0). When patients were categorized into two groups based on a total IgE cut-off value of 20 IU/ml, the group with IgE levels greater than 20 had a significantly higher proportion of full responders.

CONCLUSION

The majority of patients with CSU in this study responded well to omalizumab, with a significant proportion achieving complete responses. Additionally, higher IgE levels (>20 IU/ml) were associated with a greater likelihood of full response to treatment. These findings suggest that omalizumab is an effective agent for CSU, with the possibility of enhanced response in patients with elevated IgE levels.

摘要

目的

慢性自发性荨麻疹(CSU)的特征是反复出现风团和/或血管性水肿,持续超过6周。该疾病的特点是发作不可预测、瘙痒严重,对患者的生活质量有显著影响,常促使他们寻求医疗治疗。本研究旨在评估奥马珠单抗对CSU患者的疗效,并确定决定其有效性的因素。

方法

这项回顾性描述性研究分析了在一家三级皮肤科诊所接受奥马珠单抗治疗的159例CSU患者的注册数据。该研究记录了患者的人口统计学信息、过敏情况、奥马珠单抗剂量、治疗反应时间、疗效、使用持续时间和其他药物。研究还包括对总IgE水平的评估。

结果

在159例CSU患者中,112例(70.4%)为女性,42例(29.6%)为男性,中位年龄为43岁(四分位间距=20)。在这些患者中,156例(98.1%)接受了300mg剂量的奥马珠单抗,3例(1.9%)接受了450mg。此外,41例(25.8%)除奥马珠单抗外还需要使用抗组胺药和皮质类固醇,118例(74.2%)仅接受奥马珠单抗治疗。中位反应时间为3个月,116例(73%)显示完全缓解,39例(24.5%)显示部分缓解。4例(2.5%)无反应。当将患者分为两组——仅接受奥马珠单抗治疗的患者和联合治疗的患者时,联合治疗组对奥马珠单抗的中位反应时间在统计学上显著更长(平均值=2.53±0.76,中位数=3,四分位间距=1,而平均值=3.49±1.63,中位数=3,四分位间距=0)。当根据总IgE临界值20IU/ml将患者分为两组时,IgE水平大于20的组完全缓解者的比例显著更高。

结论

本研究中的大多数CSU患者对奥马珠单抗反应良好,很大一部分患者实现了完全缓解。此外,较高的IgE水平(>20IU/ml)与对治疗完全缓解的可能性更大相关。这些发现表明,奥马珠单抗是治疗CSU的有效药物,IgE水平升高的患者可能有更强的反应。

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本文引用的文献

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Chronic spontaneous urticaria guidelines: What is new?慢性自发性荨麻疹指南:有哪些新内容?
J Allergy Clin Immunol. 2022 Dec;150(6):1249-1255. doi: 10.1016/j.jaci.2022.10.004.

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