Department of Thoracic Medicine, University Hospital of Heraklion Crete and Medical School, University of Crete, Greece.
Pulm Pharmacol Ther. 2012 Feb;25(1):77-82. doi: 10.1016/j.pupt.2011.11.004. Epub 2011 Dec 3.
Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists.
Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational "real-life" study.
Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids).
Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (-65% p = 0.0002 at 1 year, and -70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months (p = 0.017), 1 year (p = 0.029) and 4 years (p = 0.014) of omalizumab treatment.
This long-term "real-life" study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the "real-life" practice.
奥马珠单抗是一种重组人源化抗 IgE 单克隆抗体，适用于重度过敏性哮喘的附加治疗，在吸入皮质类固醇（ICS）和长效β2-激动剂剂量较高的情况下仍控制不佳。
本非干预性、观察性“真实生活”研究使用医学登记处评估奥马珠单抗治疗的 4 个月、1 年和 4 年的疗效。
从克里特岛和塞浦路斯的 5 个东南地中海中心招募了 60 名重度持续性过敏性哮喘患者进行评估。有效性结果包括肺量测定、重度哮喘恶化率、哮喘控制水平（ACT）和附加哮喘药物（吸入性类固醇）。
奥马珠单抗治疗 4 个月后，所有观察变量均有改善，且在 1 年和 4 年后仍持续改善。FEV1 在所有时间点均与基线相比有统计学意义的显著改善[ΔFEV1（%预测值）=+21，p=0.008，治疗 4 个月后；ΔFEV1（%预测值）=+24.5，p<0.0001，治疗 4 年后]。同样，FVC 与基线相比有统计学意义的显著增加[ΔFVC（%预测值）=+20，p=0.002，治疗 4 个月后；ΔFVC（%预测值）=+22.6，p=0.0002，治疗 4 年后]。ACT 评估的哮喘控制水平治疗后显著提高（治疗 4 个月后+12%，p=0.001；治疗 4 年后+24%，p<0.0001）。奥马珠单抗治疗可显著降低哮喘恶化率（治疗 1 年后-65%，p=0.0002；治疗 4 年后-70%，p<0.0001）。奥马珠单抗治疗 4 个月后（p=0.017）、1 年（p=0.029）和 4 年（p=0.014）后，吸入性类固醇的使用均有统计学意义的减少。
这项长期的“真实生活”研究表明，奥马珠单抗治疗后肺功能和其他临床结局有显著改善，在 4 个月时就已显现，并在 1 年和 4 年后持续，提示其在重度过敏性哮喘的“真实生活”实践中的疗效。
