Effectiveness and Safety of Omalizumab in the Adjuvant Treatment of Patients With Refractory Acute Urticaria: A Real-World Case–Control Study

IF 2.5 4区医学 Q2 Medicine

Clinical and Experimental Pharmacology and Physiology Pub Date : 2026-03-12 DOI:10.1111/1440-1681.70117

Mengyan Zhu, Bo Xie, Xiaoyan Pei, Yijin Zhang, Yujian Ye

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引用次数: 0

Abstract

Background

Severe acute urticaria with systemic involvement often remains uncontrolled despite systemic corticosteroid therapy, while prolonged high-dose regimens carry significant safety risks.

Objectives

This study aimed to evaluate the effectiveness and safety of omalizumab as an adjunctive therapy in patients with refractory acute urticaria.

Methods

We conducted a single-centre, retrospective real-world case–control study of 65 patients with refractory acute urticaria selected from 3006 hospitalised patients with acute urticaria (September 2021–August 2023). Patients aged 12–75 years received either intensified corticosteroids (control group, n = 39) or 300 mg of single-dose omalizumab as an adjunct treatment to corticosteroids (omalizumab group, n = 26) after ≥ 3 days of prednisone [1 mg (kg day)⁻¹] failure. The primary outcome was postintervention corticosteroid duration.

Results

After treatment regimen adjustment, the duration of corticosteroid use was 13.00 (11.25, 15.00) days in the omalizumab group and 16.00 (13.00–17.00) days in the corticosteroid group, with a statistically significant difference (p = 0.035). Further exclusion of covariates with p < 0.05 revealed statistically significant differences in the primary outcome; the omalizumab group had 2.41 (95% CI: −4.44 to −0.37) fewer treatment days (p = 0.024, < 0.05) compared with controls. Secondary outcomes revealed a 2.41 (95% CI: −4.44 to −0.37)-day reduction in total prednisone exposure (p = 0.024), 8.70 (95% CI: −16.70 to −0.71) mg (kg day)⁻¹ lower peak prednisone dosage (p = 0.037), and cumulative prednisone dosage was reduced by 215.62 (95% CI: −388.51 to −42.73) mg following treatment adjustment (p = 0.018) in the omalizumab group versus controls. No significant intergroup differences in adverse events, hospitalisation duration, direct medication costs or progression to chronic urticaria were observed.

Conclusions

These findings suggest that omalizumab may be a safe and effective corticosteroid-sparing adjunct treatment for patients with refractory acute urticaria.

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Omalizumab辅助治疗难治性急性荨麻疹患者的有效性和安全性：一项真实世界病例对照研究

背景：全身受累的严重急性荨麻疹尽管接受全身皮质类固醇治疗，但通常仍无法控制，而长时间的高剂量方案存在显著的安全风险。目的：本研究旨在评估omalizumab作为难治性急性荨麻疹患者辅助治疗的有效性和安全性。方法：我们对3006例急性荨麻疹住院患者（2021年9月- 2023年8月）中的65例难治性急性荨麻疹患者进行了一项单中心、回顾性现实世界病例对照研究。12-75岁的患者在强的松[1 mg (kg day)-1]治疗失败≥3天后，接受强化皮质类固醇（对照组，n = 39）或300 mg单剂量omalizumab作为皮质类固醇（omalizumab组，n = 26）的辅助治疗。主要终点是干预后皮质类固醇持续时间。结果：调整治疗方案后，奥玛珠单抗组皮质类固醇使用时间为13.00（11.25,15.00）天，皮质类固醇组为16.00（13.00-17.00）天，差异有统计学意义（p = 0.035）。进一步排除p -1较低峰值泼尼松剂量的协变量（p = 0.037），并且在调整治疗后，与对照组相比，omalizumab组泼尼松累积剂量减少了215.62 mg (95% CI: -388.51至-42.73)mg （p = 0.018）。在不良事件、住院时间、直接用药费用或进展为慢性荨麻疹方面，组间无显著差异。结论：这些发现表明，omalizumab可能是一种安全有效的不使用皮质类固醇的治疗难治性急性荨麻疹的辅助治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Experimental Pharmacology and Physiology 医学-生理学

CiteScore

6.20

自引率

0.00%

发文量

128

审稿时长

6 months

期刊介绍： Clinical and Experimental Pharmacology and Physiology is an international journal founded in 1974 by Mike Rand, Austin Doyle, John Coghlan and Paul Korner. Our focus is new frontiers in physiology and pharmacology, emphasizing the translation of basic research to clinical practice. We publish original articles, invited reviews and our exciting, cutting-edge Frontiers-in-Research series’.