Steiss Jens-Oliver, Schmidt Annesuse, Rudloff Silvia
Clin Lab. 2015;61(1-2):31-7. doi: 10.7754/clin.lab.2014.140618.
The monoclonal anti-IgE antibody omalizumab is used as add-on therapy for improved asthma control in patients with severe persistent allergic bronchial asthma. The aim of the study was to examine the effectiveness of omalizumab and to demonstrate the hitherto unavailable possibilities for treatment monitoring by means of a bedside immunoassay.
In the prospective longitudinal study, 9 patients aged 8 to 15 years with severe persistent allergic asthma received add-on treatment with omalizumab. Besides the parameters of general physical examination, recordings of exacerbation rate, asthma control and lung function (FEV1), and total IgE concentrations in serum were determined after 6 and 12 months; free IgE was measured using the Milenia QuickLine immunoassay.
The mean duration of treatment was 56 ± 7.5 months. After 12 months, omalizumab showed good tolerability and effectiveness with a reduced exacerbation rate, a significant improvement of asthma control (ACT; p < 0.001) and FEV1 (p < 0.01). Already after six months of therapy, a significant reduction in total IgE from 1253 ± 407 IU/mL to 466 ± 120 IU/mL (p < 0.01) was observed. Free IgE levels were below the detection limit in all patients during treatment with omalizumab, even following dose reduction; they increased only after cessation of the treatment.
Our data 1) confirmed good therapeutic effectiveness of omalizumab in patients with severe persistent asthma and 2) indicated that a quick and easy-to-use immunoassay to measure free IgE together with thorough clinical assessment may be a potential instrument for monitoring omalizumab treatment.
单克隆抗IgE抗体奥马珠单抗用作附加疗法，以改善重度持续性过敏性支气管哮喘患者的哮喘控制。本研究的目的是检验奥马珠单抗的有效性，并通过床边免疫测定法证明迄今尚无法实现的治疗监测可能性。
在这项前瞻性纵向研究中，9名年龄在8至15岁的重度持续性过敏性哮喘患者接受了奥马珠单抗的附加治疗。除了一般体格检查参数外，在6个月和12个月后测定了加重率、哮喘控制情况和肺功能（第一秒用力呼气容积[FEV1]）记录以及血清总IgE浓度；使用Milenia QuickLine免疫测定法测量游离IgE。
平均治疗时长为56±7.5个月。12个月后，奥马珠单抗显示出良好的耐受性和有效性，加重率降低，哮喘控制情况（哮喘控制测试[ACT]；p<0.001）和FEV1（p<0.01）有显著改善。在治疗6个月后，就已观察到总IgE从1253±407IU/mL显著降至466±120IU/mL（p<0.01）。在使用奥马珠单抗治疗期间，所有患者的游离IgE水平均低于检测限，即使在剂量减少后也是如此；仅在治疗停止后其水平才升高。
我们的数据1）证实了奥马珠单抗对重度持续性哮喘患者具有良好的治疗效果，2）表明一种快速且易于使用的测量游离IgE的免疫测定法与全面的临床评估相结合可能是监测奥马珠单抗治疗的一种潜在手段。
