Charité- Universitätsmedizin Berlin, Berlin, Germany.
Allergy. 2009 Dec;64(12):1780-7. doi: 10.1111/j.1398-9995.2009.02119.x. Epub 2009 Jul 21.
Omalizumab, an anti-IgE antibody, has proven efficacy in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma. While previous analyses have had some limited success in predicting which patients will gain greatest benefit based on pretreatment baseline characteristics, it remains important to try to improve this predictability.
Following a run-in phase, patients (12-75 years) inadequately controlled despite current therapy were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicenter study (INNOVATE). Univariate analyses were performed to assess whether pretreatment specific IgE serum levels and related variables could be identified that were predictive of a response to omalizumab patients (n = 337) enrolled in INNOVATE. Response was measured via variables including exacerbations, QoL, FEV(1) and physicians' overall assessment.
A total of 305 patients (90.5%) were sensitive to more than one allergen and the majority of patients were positive to D1 Dermatophagoides pteronyssinus and D2 Dermatophagoides farinae. Patients with relatively high values of D1 or D2, but with these making a relatively low contribution to total specific IgE load, appeared to attain most benefit from omalizumab. However, no consistent predictive effect for omalizumab response was observed either for total specific IgE or levels of IgEs specific for individual allergens.
Based on these data, pretreatment allergen-specific IgE levels do not provide any better prediction of response to treatment as compared with pretreatment total IgE. At present, the most reliable method of identifying patients who respond to omalizumab treatment remains a physician's assessment.
奥马珠单抗是一种抗 IgE 抗体，已被证明对中重度和重度持续性过敏性（IgE 介导）哮喘患者有效。虽然之前的分析已经在一定程度上成功地预测了哪些患者将根据治疗前的基线特征获得最大益处，但仍有必要尝试提高这种预测能力。
在引入期后，尽管接受了当前治疗，但仍控制不佳的患者（12-75 岁）被随机分为奥马珠单抗或安慰剂组，进行为期 28 周的双盲、平行分组、多中心研究（INNOVATE）。进行单变量分析，以评估 INNOVATE 中纳入的奥马珠单抗治疗患者的治疗前特异性 IgE 血清水平和相关变量是否可以识别出对奥马珠单抗有反应的预测因子。通过包括加重、生活质量、FEV(1)和医生总体评估在内的变量来衡量反应。
共有 305 名患者（90.5%）对一种以上过敏原敏感，大多数患者对 D1 屋尘螨和 D2 粉尘螨呈阳性。对 D1 或 D2 值相对较高，但对总特异性 IgE 负荷的贡献相对较低的患者，似乎从奥马珠单抗中获益最大。然而，无论是总特异性 IgE 还是针对单个过敏原的 IgE 水平，均未观察到奥马珠单抗反应的一致预测效果。
根据这些数据，与治疗前总 IgE 相比，治疗前过敏原特异性 IgE 水平并不能提供更好的治疗反应预测。目前，识别对奥马珠单抗治疗有反应的患者最可靠的方法仍然是医生的评估。
