Predicting and evaluating response to omalizumab in patients with severe allergic asthma
Predicting and evaluating response to omalizumab in patients with severe allergic asthma
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DOI：
10.1016/j.rmed.2007.01.011
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发表时间：
2007-07-01
影响因子：
4.3
通讯作者：
Holgate, S.
中科院分区：
文献类型：
--
作者：
Bousquet, J.;Rabe, K.;Holgate, S.
背景：奥马珠单抗是一种单克隆抗体，适用于治疗尽管达到最佳效果但仍未得到充分控制的严重持续性过敏性哮喘。控制器疗法。我们调查了患者选择是否可以进一步有针对性。方法：分析了七项随机对照奥马珠单抗试验的数据，以调查是否可以确定治疗前患者基线临床特征，这些特征可以预测对奥马珠单抗的优异反应。我们还研究了是否可以可靠地识别在一个疗程后对奥马珠单抗有反应的患者。对 INNOVATE 数据进行单变量/多变量分析，以确定预测基线测量，并进一步研究七项研究汇总数据的功效分析。通过评估各种临床反应标准识别反应者和区分患者病情恶化和其他结果的能力，确定治疗后识别奥马珠单抗反应者的最佳方法。 结果：基线总免疫球蛋白 E (IgE) 是 INNOVATE 疗效的唯一预测因子。然而，汇总分析显示治疗效果与 IgE 水平无关。在接受奥马珠单抗治疗的患者中，医生在一个疗程后的总体评估将 61% 的患者确定为有反应者和最佳区分治疗结果。结论：基线特征并不能可靠地预测奥马珠单抗的获益。治疗 16 周后医生的总体评估是衡量治疗反应的最有意义的指标。 (C) 2007 Elsevier Ltd. 保留所有权利。
Background: Omalizumab is a monoclonal antibody indicated for treatment of severe persistent allergic asthma inadequately controlled despite optimal. controller therapy. We investigated whether patient selection could be targeted further.Methods: Data from seven randomized controlled omalizumab trials were analyzed to investigate whether pre-treatment patient baseline clinical characteristics could be identified that were predictive of a superior response to omalizumab. We also studied whether patients who respond to omalizumab following a course of treatment could be reliably identified. Univariate/multivariate analyses of INNOVATE data were performed to identify predictive baseline measures and further investigated in efficacy analyses of pooled data from seven studies. The best method of identifying responders to omalizumab following treatment was determined by assessing the ability of various clinical response criteria to identify responders and discriminate patient exacerbation and other outcomes.Results: Baseline total immunoglobulin E (IgE) was the only predictor of efficacy in INNOVATE. However, pooled analysis showed treatment benefits irrespective of IgE levels. In omalizumab-treated patients, physician's overall assessment following a course of treatment identified 61% as responders and best discriminated treatment outcomes.Conclusion: Baseline characteristics do not reliably predict benefit with omalizumab. Physician's overall assessment after 16 weeks of treatment is the most meaningful measure of response to therapy. (C) 2007 Elsevier Ltd. All rights reserved.