Unità di Farmacologia Clinica Respiratoria, Dipartimento di Medicina Interna Università di Roma Tor Vergata, Roma, Italy.
Respir Med. 2010 Oct;104(10):1410-6. doi: 10.1016/j.rmed.2010.04.013. Epub 2010 May 18.
Omalizumab is a humanized murine monoclonal antibody directed toward a portion of the IgE indicated in Europe for the treatment of severe persistent allergic asthma, inadequately controlled despite high-dose of ICS (mean BDP equivalent dose of inhaled corticosteroid 2224.68microg/die) in association with long-acting beta(2) agonists. Our aim was to describe the experience, efficacy and safety in a cohort of Italian patients treated with omalizumab in a real-life clinical setting. One hundred and forty two patients from 13 Italian Centers were observed and analysed. The dosage of omalizumab was established according to the labelling indication, with a median dose of IgE of 297.38IU/ml or kU/l. During the previous year, all patients experienced frequent exacerbations (mean=4.87), emergency visits (mean=4.45) and hospitalisation (mean=1.53). Following treatment with omalizumab, the annual rate of exacerbations, emergency visits and hospitalisation decreased by 79%, 88% and 95%, respectively. The proportion of patients without exacerbation, not needing emergency visits and hospitalization increased by 610%, 154% and 28%, respectively. The response to omalizumab measured with the GETE (global evaluation of treatment effectiveness) scale rated as good to excellent in 77% of patients. Overall, 9.6% (n=9) of the patients experienced one single adverse effect. Only one patient reported a serious adverse event (local reaction at the site of injection) leading to interruption of treatment. The observed reduction of asthma-related events in particularly poorly controlled patients in this Italian real-life setting is consistent with the results of other observational studies.
奥马珠单抗是一种针对 IgE 的人源化鼠单克隆抗体，在欧洲被指示用于治疗严重持续性过敏性哮喘，尽管在长效β2 激动剂的联合治疗下，患者使用了高剂量的 ICS（吸入皮质类固醇的平均 BDP 等效剂量为 2224.68μg/d），但仍控制不佳。我们的目的是在意大利的真实临床环境中描述使用奥马珠单抗治疗的意大利患者的经验、疗效和安全性。观察和分析了来自 13 个意大利中心的 142 名患者。奥马珠单抗的剂量根据标签指示确定，中位数 IgE 剂量为 297.38IU/ml 或 kU/l。在过去一年中，所有患者均经历过频繁的加重（平均=4.87）、急诊就诊（平均=4.45）和住院治疗（平均=1.53）。使用奥马珠单抗治疗后，每年的加重次数、急诊就诊次数和住院次数分别减少了 79%、88%和 95%。没有加重、不需要急诊就诊和住院的患者比例分别增加了 610%、154%和 28%。用 GETE（治疗效果整体评估）量表测量的奥马珠单抗的应答率，77%的患者评为良好至极好。总体而言，9.6%（n=9）的患者出现了 1 种单一不良反应。只有 1 例患者报告了 1 例严重不良事件（注射部位局部反应），导致治疗中断。在这种意大利真实环境中，观察到特别控制不佳的患者的哮喘相关事件减少，这与其他观察性研究的结果一致。
