BACKGROUND: Medical registries can be used to assess and monitor the effectiveness and safety of approved therapy, and provide insights into how quality of care can be optimized. METHODS: The post-marketing, non-interventional, observational registry (eXpeRience) aims to collect data on the treatment effectiveness and safety of omalizumab in 'real-world' practice. The baseline characteristics of patients with uncontrolled allergic asthma receiving omalizumab therapy and included in the first interim analysis of this observational registry are reported. RESULTS: A total of 294 patients were included in the first interim analysis. Of these patients, 271 (92.2%) were active in the registry at the time of reporting. At baseline, the mean duration of allergic asthma was approximately 19 years, with over 87% of patients testing positive for a perennial allergen. Mean % predicted FEV(1) and serum total IgE levels were 62.4% and 316.7 IU/mL, respectively. Asthma was uncontrolled for approximately 62% of patients, while around 23% were partly controlled. The majority of patients were being treated with multiple asthma controller medications, including inhaled-corticosteroids, long-acting β(2)-agonists and leukotriene receptor antagonists, and 28% of patients were also receiving maintenance oral corticosteroids. Concomitant diseases were present in many patients, the most common being perennial allergic rhinitis (42.5%). CONCLUSIONS: Demographic and disease characteristics highlight the unmet clinical need in patients with uncontrolled allergic asthma. Future analyses from this study will further determine the real-life effectiveness and safety of omalizumab.
BACKGROUND: Medical registries can be used to assess and monitor the effectiveness and safety of approved therapy, and provide insights into how quality of care can be optimized. METHODS: The post-marketing, non-interventional, observational registry (eXpeRience) aims to collect data on the treatment effectiveness and safety of omalizumab in 'real-world' practice. The baseline characteristics of patients with uncontrolled allergic asthma receiving omalizumab therapy and included in the first interim analysis of this observational registry are reported. RESULTS: A total of 294 patients were included in the first interim analysis. Of these patients, 271 (92.2%) were active in the registry at the time of reporting. At baseline, the mean duration of allergic asthma was approximately 19 years, with over 87% of patients testing positive for a perennial allergen. Mean % predicted FEV(1) and serum total IgE levels were 62.4% and 316.7 IU/mL, respectively. Asthma was uncontrolled for approximately 62% of patients, while around 23% were partly controlled. The majority of patients were being treated with multiple asthma controller medications, including inhaled-corticosteroids, long-acting β(2)-agonists and leukotriene receptor antagonists, and 28% of patients were also receiving maintenance oral corticosteroids. Concomitant diseases were present in many patients, the most common being perennial allergic rhinitis (42.5%). CONCLUSIONS: Demographic and disease characteristics highlight the unmet clinical need in patients with uncontrolled allergic asthma. Future analyses from this study will further determine the real-life effectiveness and safety of omalizumab.
Authors: María Del Carmen Vennera; Antonio Valero; Estefany Uría; Carles Forné; César Picado Journal: Clin Drug Investig Date: 2016-07 Impact factor: 2.859