The use of omalizumab in asthma.
The use of omalizumab in asthma.
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DOI：
10.3132/pcrj.2008.00031
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发表时间：
2008-06-01
期刊：
影响因子：
--
通讯作者：
Price, David
中科院分区：
文献类型：
--
作者：
Price, David
哮喘造成了沉重的发病率和死亡率负担，影响了全世界 3 亿人，预计到 2025 年这一数字将增加到 4 亿。尽管有多种治疗方案和详细的治疗指南，但许多哮喘患者，特别是严重持续性哮喘患者，仍未得到充分控制。大约 50-80% 的严重哮喘有过敏成分，免疫球蛋白 E (IgE) 在潜在的过敏性炎症级联反应中发挥作用。奥马珠单抗是一种人源化单克隆抗 IgE 抗体，靶向 IgE 并部分抑制炎症级联反应。临床试验表明，标准哮喘治疗中添加奥马珠单抗可减少哮喘发作和急诊就诊，同时改善中重度和重度持续性过敏性（IgE 介导）哮喘患者的哮喘控制和生活质量。附加奥马珠单抗适用于治疗尽管使用高剂量吸入皮质类固醇（在欧盟使用高剂量吸入皮质类固醇加长效β2受体激动剂）治疗但仍控制不充分的中度至重度（美国标签）和重度（欧盟标签）持续性过敏性哮喘的患者。在这个高度针对性的患者群体中，分析无法确定治疗前的临床特征，这些特征可以预测对奥马珠单抗的更大反应。相比之下，治疗 16 周后对奥马珠单抗的反应评估似乎是由医生在临床试验环境中可靠判断的，并且可能是选择应继续治疗的患者的可行方法。
Asthma causes a substantial burden of morbidity and mortality, affecting 300 million people worldwide - a figure predicted to increase to 400 million by 2025. Despite the availability of a variety of treatment options and detailed treatment guidelines, many patients with asthma, and in particular those with severe persistent asthma, remain inadequately controlled. Approximately 50-80% of severe asthma has an allergic component, with immunoglobulin E (IgE) playing a role in the underlying allergic inflammatory cascade. Omalizumab is a humanised monoclonal anti-IgE antibody that targets IgE and partially inhibits the inflammatory cascade. Clinical trials have demonstrated that omalizumab added to standard asthma therapy reduces exacerbations and emergency visits with concomitant improvements in asthma control and quality of life in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma. Add-on omalizumab is indicated for the treatment of patients with inadequately controlled moderate-to-severe (US label) and severe (EU label) persistent allergic asthma despite treatment with high-dose inhaled corticosteroids (and in the EU, high-dose inhaled corticosteroids plus a long-acting beta2-agonist). Within this highly-targeted patient population, analyses have been unable to identify pre-treatment clinical characteristics that are predictive of a greater response to omalizumab. In contrast, assessment of response to omalizumab following 16 weeks of treatment appears to be reliably judged by physicians in clinical trial settings and may be a feasible means of selecting patients who should continue treatment.