Hendeles Leslie, Sorkness Christine A
Department of Pharmacy Practice, College of Pharmacy and Pediatric Pulmonary Division, College of Medicine, University of Florida, Gainesville, FL, USA.
Ann Pharmacother. 2007 Sep;41(9):1397-410. doi: 10.1345/aph.1K005. Epub 2007 Aug 14.
To evaluate data on anti-immunoglobulin E (anti-IgE) therapy for asthma.
Information was selected from PubMed from 1989 to May 2007 using the search term omalizumab and included randomized, controlled trials. These studies evaluated asthma treatment with omalizumab and focused on its efficacy, tolerability, and cost-effectiveness in this population.
All randomized clinical trials were reviewed (23 were identified and 19 were included; 3 were not relevant and 1 contained duplicative data). Other articles using the search words anti-IgE therapy and cost-effectiveness were evaluated; relevant information was extracted.
IgE-dependent mechanisms play an important role in the development and maintenance of airway inflammation in asthma. Omalizumab is a subcutaneously administered monoclonal anti-IgE antibody that reduces unbound IgE concentrations and promotes down-regulation of IgE receptors. Results from clinical trials in adults, adolescents, and children with poorly controlled IgE-mediated asthma have shown that omalizumab improves symptom control and allows patients to be managed with lower doses of inhaled corticosteroids (ICS). It has been well tolerated in clinical trials lasting as long as 52 weeks, but injection-site reactions are common (45% in omalizumab group vs 43% in placebo group) and anaphylaxis has occurred in 0.2% of patients. A consensus expert panel has recommended that omalizumab should be considered for patients 12 years of age or older with allergic asthma who are inadequately controlled on guideline-based therapy and require maintenance therapy with systemic corticosteroids or high-dose ICSs, or who have poor adherence to ICS therapy.
Anti-IgE therapy provides an effective and generally safe approach to the treatment of patients with IgE-mediated asthma who are not adequately controlled by conventional guideline-based medications. However, the potential benefit must be weighed against the cost and inconvenience of this new therapy.
评估抗免疫球蛋白E（抗IgE）治疗哮喘的数据。
使用检索词“奥马珠单抗”从1989年至2007年5月的PubMed中选取信息，纳入随机对照试验。这些研究评估了奥马珠单抗治疗哮喘的情况，并重点关注其在该人群中的疗效、耐受性和成本效益。
对所有随机临床试验进行了综述（共识别出23项，纳入19项；3项不相关，1项包含重复数据）。对使用“抗IgE治疗”和“成本效益”检索词的其他文章进行了评估；提取了相关信息。
IgE依赖机制在哮喘气道炎症的发生和维持中起重要作用。奥马珠单抗是一种皮下注射的单克隆抗IgE抗体，可降低游离IgE浓度并促进IgE受体的下调。针对IgE介导的哮喘控制不佳的成人、青少年和儿童进行的临床试验结果表明，奥马珠单抗可改善症状控制，并使患者能够使用更低剂量的吸入性糖皮质激素（ICS）进行治疗。在长达52周的临床试验中，其耐受性良好，但注射部位反应较为常见（奥马珠单抗组为45%，安慰剂组为43%），0.2%的患者发生过过敏反应。一个专家共识小组建议，对于12岁及以上、经基于指南的治疗控制不佳、需要全身糖皮质激素或高剂量ICS维持治疗或对ICS治疗依从性差的过敏性哮喘患者，应考虑使用奥马珠单抗。
抗IgE治疗为治疗未被传统的基于指南的药物充分控制的IgE介导的哮喘患者提供了一种有效且总体安全的方法。然而，必须权衡这种新疗法的潜在益处与成本和不便之处。
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