奥马珠单抗治疗慢性自发性荨麻疹和慢性诱导性荨麻疹的疗效和复发分析。
Analysis of the Efficacy and Recurrence of Omalizumab Use in the Treatment of Chronic Spontaneous Urticaria and Chronic Inducible Urticaria.
机构信息
Department of Dermatology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
出版信息
Int Arch Allergy Immunol. 2023;184(7):643-655. doi: 10.1159/000529250. Epub 2023 Mar 30.
INTRODUCTION
Chronic urticaria (CU) is a common skin condition that can be divided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Omalizumab is one treatment option for CU, but currently there are limited clinical studies of omalizumab's efficacy for treating CU in Chinese patients. This study sought to investigate the efficacy and safety of omalizumab treatment for CU patients in a Chinese patient population. Specifically, we aimed to compare the differential efficacy of omalizumab for CSU and CIndU patients and predict risk factors for recurrence.
METHODS
We completed a retrospective clinical data review of 130 CU patients who received omalizumab treatment from August 2020 to May 2022, with a maximum follow-up period of 18 months.
RESULTS
A total of 108 CSU patients and 22 CIndU patients were included in the study. After treatment with omalizumab, the response rate in the CSU group was higher than that in the CIndU group (93.5% vs. 68.2%), and CSU patients accounted for a higher proportion of responders and early responders (responders: 87.1% vs. 12.9%, p < 0.001; early responders: 95.7% vs. 4.3%, p = 0.001). Nonresponders had lower total immunoglobulin E (IgE) levels (75.0 vs. 167.5 IU/mL, p = 0.046) and a relatively shorter duration of treatment (1.0 vs. 3.0 months, p = 0.009) compared to responders. Early responders had shorter disease duration (1.0 vs. 3.0 years, p = 0.028), higher baseline UCT (4.0 vs. 2.0, p = 0.034), lower baseline DLQI (18.0 vs. 18.5, p = 0.026), and shorter total treatment time (2.0 vs. 4.0 months, p < 0.001) compared to late responders. All adverse events reported during treatment were mild. Seventy-four patients with CU discontinued the drug after achieving complete disease control, of which 26 (35.1%) relapsed for 2.0 months (interquartile range: 1.0-3.0 months). Compared with nonrelapsed patients, relapsed patients often had other allergic diseases (42.3% vs. 18.8%, p = 0.029), higher basal levels of total IgE (263.0 vs. 140.0 IU/mL, p = 0.033), and longer disease duration (4.2 vs. 1.0 years, p = 0.002). Relapsed patients could still achieve good disease control after restarting omalizumab therapy.
CONCLUSION
Omalizumab was effective and safe for CSU and CIndU patients. Patients with CSU responded more quickly to omalizumab and showed a relatively better treatment effect. However, there was a possibility of relapse after discontinuation of omalizumab after complete control of CU, and in these cases, restarting omalizumab treatment after relapse was effective.
简介
慢性荨麻疹（CU）是一种常见的皮肤疾病，可以分为慢性自发性荨麻疹（CSU）和慢性诱导性荨麻疹（CIndU）。奥马珠单抗是 CU 的一种治疗选择，但目前在中国患者中，奥马珠单抗治疗 CU 的疗效的临床研究有限。本研究旨在调查奥马珠单抗治疗中国 CU 患者的疗效和安全性，并预测复发的风险因素。
方法
我们对 2020 年 8 月至 2022 年 5 月期间接受奥马珠单抗治疗的 130 例 CU 患者的回顾性临床数据进行了分析，随访时间最长为 18 个月。
结果
共纳入 108 例 CSU 患者和 22 例 CIndU 患者。奥马珠单抗治疗后，CSU 组的应答率高于 CIndU 组（93.5% vs. 68.2%），CSU 患者中应答者和早期应答者的比例更高（应答者：87.1% vs. 12.9%，p < 0.001；早期应答者：95.7% vs. 4.3%，p = 0.001）。与应答者相比，无应答者的总免疫球蛋白 E（IgE）水平较低（75.0 vs. 167.5 IU/mL，p = 0.046），治疗时间相对较短（1.0 vs. 3.0 个月，p = 0.009）。早期应答者的疾病持续时间较短（1.0 vs. 3.0 年，p = 0.028），基线 UCT 较高（4.0 vs. 2.0，p = 0.034），基线 DLQI 较低（18.0 vs. 18.5，p = 0.026），总治疗时间较短（2.0 vs. 4.0 个月，p < 0.001）。治疗期间报告的所有不良事件均为轻度。74 例 CU 患者在达到完全疾病控制后停药，其中 26 例（35.1%）复发，复发时间为 2.0 个月（四分位距：1.0-3.0 个月）。与未复发患者相比，复发患者常有其他过敏性疾病（42.3% vs. 18.8%，p = 0.029），总 IgE 水平较高（263.0 vs. 140.0 IU/mL，p = 0.033），疾病持续时间较长（4.2 vs. 1.0 年，p = 0.002）。复发患者在重新开始奥马珠单抗治疗后仍能达到良好的疾病控制。
结论
奥马珠单抗对 CSU 和 CIndU 患者有效且安全。CSU 患者对奥马珠单抗的应答更快，治疗效果相对更好。然而，在 CU 完全控制后停用奥马珠单抗可能会复发，在这些情况下，复发后重新开始奥马珠单抗治疗是有效的。
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