Abstract

Background

Omalizumab is an effective and safe treatment for antihistamine resistant chronic spontaneous urticaria (CSU), however, long-term efficacy and safety remains unclear.

Objective

To evaluate the efficacy and safety of omalizumab in CSU patients treated for long term and to identify long-term management strategies.

Methods

We retrospectively analyzed demographic characteristics, clinical features, laboratory parameters and treatment outcomes of 41 CSU patients who received omalizumab for at least 3 years. Treatment responses were evaluated with urticaria control test (UCT). Treatment safety was evaluated by comparing laboratory findings before and three years after omalizumab initiation as well as considering patients’ adverse event reports.

Results

The patients (mean age 40.46 years; 63.4% women) received omalizumab for an average of 41.93 months (mean 31.68 injections/patient). The mean baseline UCT score was 5.56 and average number of injections to reach UCT score ≥12 was 3.3. Nine patients (22%) responded insufficiently to 300 mg/4 weeks omalizumab and required updosing. Thirty-eight patients (92.7%) could tolerate longer dose intervals (>4 weeks) and the dose interval was increased after a mean of 11.53 injections. There was no loss of efficacy of omalizumab. Sixteen patients (39%) had been retreated with omalizumab after a mean discontinuation time of 24 weeks. Five patients (12.2%) reported mild and transient adverse effects. Liver and renal function tests as well as full blood count before and after omalizumab were in normal ranges.

Conclusion

For the long-term management of CSU, omalizumab is a safe and effective treatment which can be tailored according to patients’ disease activity.

中文翻译：

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以患者为导向的长期使用奥马珠单抗治疗慢性自发性荨麻疹的方法

摘要

背景

奥马珠单抗是治疗抗组胺药耐药的慢性自发性荨麻疹（CSU）的一种有效且安全的治疗方法，但长期疗效和安全性尚不清楚。

客观的

评估奥马珠单抗在长期治疗的 CSU 患者中的疗效和安全性，并确定长期管理策略。

方法

我们回顾性分析了 41 名接受奥马珠单抗治疗至少 3 年的 CSU 患者的人口统计学特征、临床特征、实验室参数和治疗结果。用荨麻疹控制试验（UCT）评估治疗反应。通过比较奥马珠单抗开始前和三年后的实验室结果以及考虑患者的不良事件报告来评估治疗安全性。

结果

患者（平均年龄 40.46 岁；63.4% 女性）接受奥马珠单抗治疗平均 41.93 个月（平均 31.68 次注射/患者）。平均基线 UCT 评分为 5.56，达到 UCT 评分≥12 的平均注射次数为 3.3。9 名患者 (22%) 对 300 mg/4 周的奥马珠单抗反应不足，需要加药。38 名患者 (92.7%) 可以耐受更长的给药间隔（>4 周），平均 11.53 次注射后给药间隔增加。奥马珠单抗的疗效没有损失。平均停药时间为 24 周后，16 名患者 (39%) 接受了奥马珠单抗治疗。五名患者（12.2%）报告了轻微和短暂的不良反应。奥马珠单抗前后的肝肾功能检查以及全血细胞计数均在正常范围内。

结论

对于 CSU 的长期管理，奥马珠单抗是一种安全有效的治疗方法，可以根据患者的疾病活动度进行调整。