Abstract
BackgroundOmalizumab (Xolair®), a recombinant monoclonal anti-IgE antibody, has demonstrated efficacy in clinical trials conducted in patients with moderate to severe persistent allergic asthma. We aimed to investigate the efficacy, discontinuation and medical resource utilization of omalizumab in the real-life setting in Taiwan.MethodsThis study was a retrospective, population-based database cohort study using the Taiwan NHIRD from 2007 to 2011 assessing the efficacy of omalizumab therapy over 4 months on changes in asthma medication, asthma control, frequency of exacerbations and hospitalization rates at baseline and after omalizumab discontinuation.ResultsThere was a reduction in asthma medication post omalizumab therapy and severe exacerbations and hospitalizations from baseline (31.2 %, n = 282) to the end of follow-up (11.8 %, n = 144, p < 0.001). Nearly all the patients received chronic oral corticosteroids at baseline (92.4 %). The number of ER visits decreased from 1.13 ± 2.04 to 0.29 ± 0.83, and the mean number of admissions decreased from 5.93 ± 16.16 to 2.75 ± 12.02 from baseline to the end of follow-up (p < 0.001). After discontinuation of omalizumab, the cost of ER medical expenses decreased from New Taiwan dollars (NTD) 3934 at 2 months to NTD 2860 at 12 months.ConclusionsPatients who received omalizumab therapy for over 4 months were more likely to reduce the use of other asthma medications and less likely to experience an asthma exacerbation, ER visits, and hospitalization, even after the discontinuation of omalizumab. These data suggest that omalizumab has efficacy in improving health outcomes in patients with moderate to severe predominately chronic oral steroid dependent asthma in the real-life setting in Taiwan.
Highlights
Omalizumab (Xolair®), a recombinant monoclonal anti-IgE antibody, has demonstrated efficacy in clinical trials conducted in patients with moderate to severe persistent allergic asthma
There were 46, 130, 156, 196 patients prescribed with omalizumab, respectively, based on which year they received it in the National Health Insurance Research Database (NHIRD) claims database, allowing to quantify the patterns of omalizumab usage and other anti-asthmatic regimen in routine practice with sufficient precision
46, 130, 156, and 196 patients received omalizumab in 2008, 2009, 2010, and 2011, respectively, based on which year they received it in the NHIRD claims database, The prescribing pattern and duration of omalizumab treatment In total, 282 patients (161 male, 57.1 %) who received omalizumab had moderate to severe asthma with mean age of 51.3 ± 17.2 years
Summary
Omalizumab (Xolair®), a recombinant monoclonal anti-IgE antibody, has demonstrated efficacy in clinical trials conducted in patients with moderate to severe persistent allergic asthma. Omalizumab (Xolair®), a recombinant monoclonal anti-IgE antibody, has demonstrated efficacy in clinical trials conducted in patients with moderate to severe and severe persistent allergic. Numerous randomized clinical trials have shown that adding omalizumab to current asthma therapy is effective and well tolerated [9,10,11,12] Data from these clinical studies have shown that add-on therapy with omalizumab significantly reduces asthma exacerbations, use of ICS and ER/hospital visits. A 2-year, international, post-marketing observation registry (eXpeRience) [14] was conducted to evaluate the real-world effectiveness, safety and use of omalizumab therapy in 943 patients with uncontrolled persistent allergic asthma. The results confirmed the effectiveness of omalizumab in improving asthma control, the number and severity of exacerbations, symptoms, lung function and healthcare utilization, both in a real-world setting and in a clinically controlled study setting
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