"Real-life" Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis
"Real-life" Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis
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DOI：
10.1016/j.jaip.2017.02.002
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发表时间：
2017-09-01
影响因子：
9.4
通讯作者：
Abraham, Ivo
中科院分区：
文献类型：
--
作者：
Alhossan, Abdulaziz;Lee, Christopher S.;Abraham, Ivo
背景技术背景：奥马珠单抗获批用于严重过敏性哮喘后，共有25项研究评估了奥马珠单抗在患者、临床医生、研究中心和治疗模式异质性的“现实生活”条件下的有效性。目的：我们进行了一项荟萃分析，以评估奥马珠单抗的有效性，重点是治疗反应，肺功能，生活质量，症状控制，皮质类固醇使用，方法：我们在PubMed和Embase中检索了截至2015年发表的关于奥马珠单抗治疗严重哮喘的真实研究。提取了三种效应量类型：单点比例;相对于基线变化的平均值+/- SD作为原始数字，标准化为Cohen d;患者比例的变化作为相对风险。进行随机效应荟萃分析以解释研究内和研究间异质性。研究加权DerSimonian和Laird方法。结果：根据3个时间点的可用数据，奥马珠单抗治疗与大部分归类为“良好”至“优秀”治疗应答者的患者一致相关（全球治疗效果评价量表）; 1秒用力呼气量、生活质量改善（哮喘相关生活质量问卷量表）和哮喘症状控制（哮喘控制测试量表）;减少口服和吸入皮质类固醇（ICS）的使用;以及减少急性发作和住院治疗。这项非对照研究的荟萃分析记录了奥马珠单抗作为ICS +/-长效β 2受体激动剂的辅助治疗在患者、临床医生、研究中心和治疗模式异质性条件下改善重度过敏性哮喘患者结局的实际药理学有效性。这些结果反映、补充和扩展了来自随机对照试验的疗效数据。(C)2017年美国过敏、哮喘和免疫学会
BACKGROUND: After the approval of omalizumab for severe allergic asthma, a total of 25 studies have evaluated the effectiveness of omalizumab under "real-life" conditions of heterogeneity in patients, clinicians, sites, and treatment patterns.OBJECTIVE: We conducted a meta-analysis to evaluate the effectiveness of omalizumab focusing on treatment response, lung function, quality of life, symptom control, corticosteroid use, and exacerbations and hospitalizations at 4-6, 12, and 24 months.METHODS: We searched PubMed and Embase for real-life studies on omalizumab in severe asthma published up to 2015. Three effect size types were extracted: single-point proportions; mean +/- SD of change relative to baseline as raw numbers and standardized as Cohen's d; and changes in proportions of patients as relative risk. Random-effects meta-analyses were performed to account for within-and between-study heterogeneity. Studies were weighted by the DerSimonian and Laird method.RESULTS: Per data available at the 3 time points, omalizumab therapy was consistently associated with large proportions of patients classified as "good" to "excellent" treatment responders (Global Evaluation of Treatment Effectiveness scale); improvements in forced expiratory volume in 1 second, quality of life (Asthma-related Quality-of-Life Questionnaire scale), and asthma symptom control (Asthma Control Test scale); reductions in oral and inhaled corticosteroid (ICS) use; and reductions in exacerbations and hospitalizations.CONCLUSIONS: This meta-analysis of noncontrolled studies documents the real-life pharmacotherapeutic effectiveness of omalizumab, as add-on treatment to ICS +/- long-acting beta 2-agonists agents, in improving outcomes in patients with severe allergic asthma under conditions of heterogeneity in patients, clinicians, sites, and treatment patterns. The results mirror, complement, and extend the efficacy data from randomized controlled trials. (C) 2017 American Academy of Allergy, Asthma & Immunology