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奥马珠单抗治疗慢性荨麻疹的真实临床经验。

Real-life experiences with omalizumab for the treatment of chronic urticaria.

机构信息

Division of Allergy and Clinical Immunology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Centre de recherche appliquée en allergie de Québec, Laval University, Quebec City, Quebec, Canada.

出版信息

Ann Allergy Asthma Immunol. 2014 Feb;112(2):170-4. doi: 10.1016/j.anai.2013.12.005. Epub 2013 Dec 28.

Abstract

BACKGROUND

Evidence has shown that omalizumab, a subcutaneous anti-IgE monoclonal antibody, is highly effective for the treatment of chronic urticaria.

OBJECTIVE

To evaluate omalizumab 150 mg/month in severe, difficult-to-treat, chronic urticaria in a real-life setting.

METHODS

This prospective open-label study evaluated of 150 mg of omalizumab in severe urticaria defined by a 7-day urticaria activity score (UAS-7) higher than 30, a history of oral glucocorticoid use, and by suboptimal response to previous treatments. Two subgroups of patients at different centers (Toronto and Quebec City, Canada) were included. The primary efficacy evaluation was a change in UAS-7 from baseline. A quantitative medication score assessed the use of other anti-urticarial medications.

RESULTS

Sixty-eight patients were included: 61 with chronic spontaneous urticaria, 6 with cold urticaria, and 1 with urticarial vasculitis. Patients were followed for up to 25 months. In Toronto, mean UAS-7 decreased from 32.2 at baseline to 5.7 after the last omalizumab treatment. Seventy-nine percent achieved complete remission during omalizumab therapy (UAS-7 0) and 6 (18%) showed improvement but never achieved complete remission. The most common maintenance dosing intervals were 1 to 3 months. In Quebec City, from baseline to 18 months, mean UAS-7 decreased from 24.4 to 2.2 and the quantitative medication score decreased from 13.3 to 3.0. All 6 patients with cold urticaria became symptom free, with a significant decrease of their cold stimulation tolerance test.

CONCLUSION

Omalizumab 150 mg was effective in difficult to treat patients with severe, chronic urticaria refractory to recommended treatments who usually required prednisone. Omalizumab induced a long-lasting positive response and was well tolerated without side effects.

摘要

背景

有证据表明,皮下注射抗 IgE 单克隆抗体奥马珠单抗对于治疗慢性荨麻疹非常有效。

目的

在真实环境中评估奥马珠单抗 150 mg/月治疗重度、难治性慢性荨麻疹的疗效。

方法

本前瞻性、开放性标签研究纳入了重度荨麻疹患者(7 天荨麻疹活动评分(UAS-7)>30 分、曾使用口服糖皮质激素治疗且既往治疗反应不佳),奥马珠单抗起始剂量为 150 mg。研究纳入了来自加拿大多伦多和魁北克市两个不同中心的患者亚组。主要疗效评估指标为 UAS-7 自基线的变化。采用定量药物评分评估其他抗荨麻疹药物的使用情况。

结果

共纳入 68 例患者:慢性自发性荨麻疹 61 例、冷性荨麻疹 6 例、荨麻疹性血管炎 1 例。患者的随访时间最长达 25 个月。在多伦多,UAS-7 从基线时的 32.2 分降至末次奥马珠单抗治疗后的 5.7 分。79%的患者在奥马珠单抗治疗期间达到完全缓解(UAS-7=0),6 例(18%)患者缓解但从未达到完全缓解。最常见的维持治疗间隔为 1-3 个月。在魁北克,从基线至 18 个月,UAS-7 从 24.4 分降至 2.2 分,定量药物评分从 13.3 分降至 3.0 分。6 例冷性荨麻疹患者均症状消失,冷激发耐受试验显著改善。

结论

奥马珠单抗 150 mg 治疗对推荐治疗无效、通常需要使用泼尼松的重度、难治性慢性荨麻疹患者有效。奥马珠单抗诱导持久的积极反应,且耐受性良好,无不良反应。

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