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奥马珠单抗治疗慢性荨麻疹应答和无应答患者的比较:一项单中心回顾性研究。

Comparison of the Patients with Chronic Urticaria Who Responded and Did Not Respond to Omalizumab Treatment: A Single-Center Retrospective Study.

机构信息

Department of Allergy and Clinical Immunology, Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey.

出版信息

Int Arch Allergy Immunol. 2022;183(11):1209-1215. doi: 10.1159/000526205. Epub 2022 Aug 25.

Abstract

INTRODUCTION

Chronic urticaria (CU) is a condition usually lasting longer than 6 weeks, with wheals and angioedema, sometimes both. Omalizumab is a recombinant humanized monoclonal IgG antibody developed against IgE. In some patients with CU, treatment response to omalizumab is good, but in some patients, it is poor. We aimed to compare the clinical features and laboratory parameters of the patients who responded and did not respond to omalizumab treatment among patients diagnosed with CU.

METHODS

Patients treated with omalizumab for the diagnosis of CU were evaluated retrospectively. Treatment response to omaliz-umab was evaluated by urticaria control test (UCT) (responder to omalizumab: UCT score ≥12 at 6 months and an increase of ≥3 compared to baseline). The clinical features and laboratory parameters of the patients who responded and did not respond to treatment were compared.

RESULTS

The mean age of the 220 patients, 66 (30%) men and 154 (70%) women, who received 300 mg of sc omalizumab every 4 weeks for CU was 38.89 ± 12.76 years. One hundred eighty-nine (85.9%) patients had good response to omalizumab treatment at the end of 6 months. Atopy (n = 73 [38.6%], p = 0.026), eosinophil count (median = 190 [0-800] [cells/µL], p < 0.001), basophil count (median = 40 [0-100] [cells/µL], p = 0.021), and total IgE (median = 240.5 [45-2,644] [kU/L], p < 0.001) level were significantly higher in the omalizumab responder patients (UCT score ≥12 at 6 months and an increase of ≥3 compared to baseline). Psychiatric disorders (n = 13 [41.9%], p = 0.008) and anti-TG (n = 11 [35.5%] [>2 IU/mL positive], p = 0.024) were significantly higher in the oma-lizumab nonresponder patients (UCT score ≤11 at 6 months). A weak but significant clinical correlation was found between blood eosinophil count (r = 0.168, p = 0.013), blood lymphocyte count (r = -0.149, p = 0.027), total IgE level (r = 0.207, p = 0.002), and increase in UCT score. As a result of the ROC curve analysis, the blood eosinophil count (AUC: 0.763, p < 0.001), total IgE level (AUC: 0.866, p < 0.001), and blood basophil count (AUC: 0.662, p = 0.004) had diagnostic value in predicting the response to omalizumab treatment in patients with CU.

CONCLUSION

The patients with CU who were atopic with high eosinophils, high basophils, and high total IgE levels had good response to omalizumab treatment, but the patients with concomitant psychiatric disease and positive thyroid autoantibodies had poor response to omalizu-mab treatment. These findings obtained in our study should be tested in randomized controlled studies.

摘要

简介

慢性荨麻疹(CU)通常是指持续时间超过 6 周的荨麻疹,伴有风团和血管性水肿,有时两者兼有。奥马珠单抗是一种针对 IgE 的重组人源化单克隆 IgG 抗体。在一些 CU 患者中,奥马珠单抗治疗的反应良好,但在一些患者中,反应较差。我们旨在比较 CU 患者中对奥马珠单抗治疗有反应和无反应的患者的临床特征和实验室参数。

方法

回顾性评估接受奥马珠单抗治疗的 CU 患者。通过荨麻疹控制测试(UCT)(奥马珠单抗治疗有反应:6 个月时 UCT 评分≥12,与基线相比增加≥3)评估奥马珠单抗治疗的反应。比较对治疗有反应和无反应的患者的临床特征和实验室参数。

结果

220 名接受 sc 奥马珠单抗 300mg 每 4 周治疗 CU 的患者的平均年龄为 38.89±12.76 岁,其中 66 名(30%)为男性,154 名(70%)为女性。189 名(85.9%)患者在 6 个月末对奥马珠单抗治疗有良好反应。特应性(n=73[38.6%],p=0.026)、嗜酸性粒细胞计数(中位数=190[0-800] [细胞/µL],p<0.001)、嗜碱性粒细胞计数(中位数=40[0-100] [细胞/µL],p=0.021)和总 IgE 水平(中位数=240.5[45-2644] [kU/L],p<0.001)在奥马珠单抗有反应的患者中显著升高。精神障碍(n=13[41.9%],p=0.008)和抗 TG(n=11[35.5%] [>2 IU/mL 阳性],p=0.024)在奥马珠单抗无反应的患者中显著升高。在奥马珠单抗无反应的患者中,血液嗜酸性粒细胞计数(r=0.168,p=0.013)、血液淋巴细胞计数(r=-0.149,p=0.027)、总 IgE 水平(r=0.207,p=0.002)和 UCT 评分增加之间存在弱但有统计学意义的临床相关性。ROC 曲线分析结果显示,血液嗜酸性粒细胞计数(AUC:0.763,p<0.001)、总 IgE 水平(AUC:0.866,p<0.001)和血液嗜碱性粒细胞计数(AUC:0.662,p=0.004)对预测 CU 患者对奥马珠单抗治疗的反应具有诊断价值。

结论

特应性、高嗜酸性粒细胞、高嗜碱性粒细胞和高总 IgE 水平的 CU 患者对奥马珠单抗治疗反应良好,但伴有精神疾病和甲状腺自身抗体阳性的患者对奥马珠单抗治疗反应较差。我们在这项研究中获得的这些发现应该在随机对照研究中进行测试。

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