监测奥玛珠单抗治疗的严重哮喘患者血清游离IgE
2012/10/11
摘要
背景：对于IgE依赖型哮喘，IgE单克隆抗体（奥玛珠单抗）治疗的疗效取决于血清游离IgE是否显著下降。对于奥玛珠单抗治疗的哮喘患者，目前尚不清楚监测血清游离IgE是否有助于临床哮喘的控制。
方法：4个月内，采用Recovery-ELISA检测22名奥玛珠单抗治疗的严重哮喘患者的血清游离IgE和奥玛珠单抗浓度（68%为女性，平均年龄47 ± 11岁，支气管扩张剂使用前FEV1为62 ± 13%；基础血清游离IgE为652 ± 136 ng/ml）。
结果：在第二次奥玛珠单抗治疗前，血清游离IgE浓度下降73%，治疗16周后，血清游离IgE浓度下降81%，下降至58 ± 12 ng/ml（与基础水平相比：P< 0.001）。基于医生对总体疗效的评价，17名患者对抗IgE治疗有效。血清游离IgE浓度与治疗反应无相关性，血清游离IgE与肺功能变化、呼出气NO、哮喘控制和生活质量也无关。所有患者检测血清奥玛珠单抗浓度，血药浓度在治疗8周内达到稳定。
结论：对奥玛珠单抗治疗的患者进行血清游离IgE和奥玛珠单抗检测，不能预测治疗的临床反应，也对临床判断断是否需继续治疗没有帮助。然而，对于奥玛珠单抗治疗无效的患者，常规检测血清游离IgE可以观察血清游离IgE是否充分下降。
（刘国梁 审校）
Respir Med. 2012 Aug 9. [Epub ahead of print]
Monitoring free serum IgE in severe asthma patients treated with omalizumab.
Korn S, Haasler I, Fliedner F, Becher G, Strohner P, Staatz A, Taube C, Buhl R.
Source
Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, D-55131 Mainz, Germany.
Abstract
BACKGROUND: Benefit of treatment with the monoclonal anti-IgE-antibody omalizumab in severe IgE-dependent asthma requires a significant reduction of serum free IgE concentrations. It is unclear if monitoring free serum IgE is clinically meaningful once omalizumab treatment is initiated.
METHODS: Free IgE and omalizumab serum concentrations were quantified in 22 patients with severe asthma (68% female, 47 ± 11 yrs, mean (±SD) pre-bronchodilator FEV(1) 62 ± 13%, baseline mean (±SEM) free serum IgE 652 ± 136 ng/ml) treated with omalizumab for 4 months using a Recovery-ELISA.
RESULTS: Omalizumab treatment reduced free serum IgE prior to the second omalizumab injection by 73%, after 16 weeks by 81% to 58 ± 12 ng/ml (p < 0.001 vs. baseline). 17 patients responded to anti-IgE therapy as judged by physician-rated global evaluation of treatment effectiveness. There was neither a relation between free serum IgE concentrations and treatment response nor a significant or clinically relevant correlation between free IgE levels and changes in lung function, exhaled NO, asthma control, and quality of life. Serum concentrations of omalizumab were detected in all patients and reached a stable phase within 8 weeks.
CONCLUSIONS: Monitoring free IgE and omalizumab serum concentrations in patients treated with omalizumab does not predict clinical response nor does it add to the decision to continue or stop treatment. However, routine measurements of free IgE may be clinically relevant to demonstrate an adequate reduction in free IgE in patients not responding to omalizumab therapy.
Respir Med. 2012 Aug 9. [Epub ahead of print]
