Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting
Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting
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DOI：
10.1186/1710-1492-9-47
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发表时间：
2013-12-04
影响因子：
2.7
通讯作者：
Chen, Chien-Wei
中科院分区：
文献类型：
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作者：
Braunstahl, Gert-Jan;Chlumsky, Jan;Chen, Chien-Wei
背景：严重持续性过敏性哮喘患者通常使用口服皮质类固醇（OCS）。尽管它们有效，但它们与各种不良事件相关。建立eXpeRience登记研究是为了调查接受奥马珠单抗治疗不受控制的过敏性哮喘患者的真实结局。在这里，我们提出了奥马珠单抗治疗对OCS use.Methods的影响：eXpeRience是一个为期2年的，多国，非干预性，观察性登记的患者接受奥马珠单抗治疗不受控制的过敏性哮喘。在基线、奥马珠单抗治疗开始后16周、8、12、18和24个月评估OCS使用情况（接受维持OCS的患者比例、平均每日OCS总剂量和OCS治疗状态的变化）。在大约第16周时，使用医生的治疗有效性总体评价（GETE）评估对奥马珠单抗的应答。安全性数据也recorded.Results：共943例患者（平均年龄45岁，女性，64.9%）登记，其中263人在基线接受维持OCS。第12个月（16.1%）和第24个月（14.2%）时接受维持OCS的患者比例显著低于基线时（28.6%;意向治疗人群）。在915例接受omalizumab治疗的患者中确定了GETE状态：64.2%为应答者（极好或良好应答），30.7%为无应答者（中度、较差或恶化应答）; 5.1%未进行评估。严重不良事件的发生频率与对照试验omalizumab.Conclusions中观察到的频率相当：在现实环境中，奥马珠单抗的使用与不受控制的持续性过敏性哮喘患者的OCS保留效应相关。
Background: Oral corticosteroids (OCS) are commonly administered in patients with severe persistent allergic asthma. Despite their efficacy, they are associated with a wide variety of adverse events. The eXpeRience registry was set up to investigate real-world outcomes among patients receiving omalizumab for the treatment of uncontrolled allergic asthma. Here, we present the effect of omalizumab treatment on OCS use.Methods: eXpeRience was a 2-year, multinational, non-interventional, observational registry of patients receiving omalizumab for uncontrolled allergic asthma. OCS use (proportion of patients on maintenance OCS, mean total daily OCS dose and change in status of OCS therapy) was assessed at baseline, 16 weeks, and 8, 12, 18, and 24 months after the initiation of omalizumab. Response to omalizumab was assessed using the physician's Global Evaluation of Treatment Effectiveness (GETE) at approximately Week 16. Safety data were also recorded.Results: A total of 943 patients (mean age, 45 years; female, 64.9%) were enrolled in the registry, 263 of whom were receiving maintenance OCS at baseline. The proportion of patients taking maintenance OCS was markedly lower at Months 12 (16.1%) and 24 (14.2%) than at baseline (28.6%; intent-to-treat population). GETE status was determined in 915 patients receiving omalizumab: 64.2% were responders (excellent or good response), 30.7% were non-responders (moderate, poor or worsening response); 5.1% had no assessment. The frequency of serious adverse events was comparable to that seen in controlled trials of omalizumab.Conclusions: Omalizumab use is associated with an OCS-sparing effect in patients with uncontrolled persistent allergic asthma in the real-world setting.