Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting

被引:53
|
作者
Braunstahl, Gert-Jan [1 ]
Chlumsky, Jan [2 ]
Peachey, Guy [3 ]
Chen, Chien-Wei [4 ]
机构
[1] St Franciscus Gasthuis, Dept Pulm Med, NL-3045 PM Rotterdam, Netherlands
[2] Charles Univ Prague, Thomayer Hosp, Dept Pulm Dis, Prague, Czech Republic
[3] Novartis Pharmaceut UK Ltd, Horsham, W Sussex, England
[4] Novartis Pharmaceut, E Hanover, NJ USA
关键词
Anti-immunoglobulin E; Oral corticosteroid use; Omalizumab; Registry; Uncontrolled persistent allergic asthma; IGE-MEDIATED ASTHMA; ANTIBODY OMALIZUMAB; EXPERIENCE REGISTRY; ADVERSE EVENTS; THERAPY;
D O I
10.1186/1710-1492-9-47
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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.
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页数:7
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