Background

Omalizumab is useful as an add-on treatment in patients unresponsive to high doses of second-generation antihistamines. This study aimed to evaluate the efficacy and safety of omalizumab treatment in adolescents with refractory chronic spontaneous urticaria (CSU).

Methods

CSU patients aged 12–18 years old with the diagnosis of symptomatic CSU and unresponsive to classical treatment were included in the study. All patients had an urticaria-activity-score (UAS7) of ≥16 or and were treated with 300 mg omalizumab every four weeks. The degree of response was classified into complete, partial and non-responders due to UAS7.

Results

A total of 29 patients were evaluated. The median age and symptom onset age of the patients was 15.2 (IQR, 12.8–16.5) years and 14.0 (IQR, 11.8–15.9) years, respectively. The median duration of urticaria was eight (IQR, 4–24) months at admission. Eleven (37.9%) patients had angioedema and ten (34.5%) patients had concomitant allergic diseases. The median age at the beginning of treatment with omalizumab was 15.4 (IQR, 12.9–16.9) years. The median symptom duration was 12 (IQR, 6.5–27.5) months before the omalizumab treatment. Twenty-eight (96.5%) of the patients (89.6% complete, 6.9% partial) achieved response; however, one patient was a non-responder (3.5%). The adverse effect was observed in one (3.4%) patient as angioedema after the third dose. Twenty-three patients were followed up for a median of 18 (IQR, 13–27) months. Relapse was observed in three (13%) patients.

Conclusions

Omalizumab is considered as an effective and safe treatment for CSU in adolescents. Relapses mostly occur within the first year after the cessation of treatment.

中文翻译：

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奥马珠单抗治疗慢性自发性荨麻疹青少年的疗效和安全性。

背景

奥马珠单抗可用作​​对大剂量第二代抗组胺药无反应的患者的附加治疗。这项研究旨在评估奥马珠单抗治疗难治性慢性自发性荨麻疹（CSU）的疗效和安全性。

方法

该研究包括12-18岁的CSU患者，这些患者被诊断为有症状的CSU，对经典治疗无反应。所有患者的荨麻疹活动评分（UAS7）≥16或每四周接受300 mg奥马珠单抗治疗。由于UAS7，响应程度分为完全响应，部分响应和不响应。

结果

总共评估了29名患者。患者的中位年龄和症状发作年龄分别为15.2（IQR，12.8-16.5）岁和14.0（IQR，11.8-15.9）岁。入院时荨麻疹的中位持续时间为八个月（IQR，4-24）。十一名（37.9％）患者患有血管性水肿，十名（34.5％）患者患有伴随的过敏性疾病。奥马珠单抗治疗开始时的中位年龄为15.4（IQR，12.9-16.9）岁。在接受奥马珠单抗治疗之前，中位症状持续时间为12（IQR，6.5–27.5）个月。28名（96.5％）患者（完成的89.6％，部分6.9％）获得了缓解；但是，一名患者没有反应（3.5％）。在第三次给药后，在一名（3.4％）患者中观察到了血管水肿的不良反应。对23例患者进行了随访，平均中位时间为18个月（IQR，13–27）。

结论

奥马珠单抗被认为是青少年CSU的有效且安全的治疗方法。复发多发生在停止治疗后的第一年内。