Efficacy of omalizumab in Polish real-world patients

Background: Omalizumab(OMA) is the youngest medicine in asthma therapy. It is being evaluated in real-world clinical practice to provide complete understanding of the benefit of this otherwise expensive medicine. Objectives: To evaluate efficacy of OMA during one year of therapy in real-life conditions in Polish patients with severe allergic asthma. Methods: Due to the introduction of Program for Severe Allergic Asthma funded by the National Health Insurance OMA became more commonly available for Polish patients. Strict inclusion criteria should be met to enter the program. The study is one-year open-label observation lead in 15 patients qualified to the program in Pulmonary Department in Krakow. All patients have been assessed for asthma control (Asthma Control Questionnaire-ACQ), quality of life (Asthma Quality of Life Questionnaire-AQLQ), daily dose of oral corticosteroids (OCS) and asthma exacerbation rate. Results: All patients have shown good (47%,n=7,GR) or very good (53%,n=8) response (VGR) to OMA according to Global Evaluation of Treatment Effectiveness (GETE) scale after one-year therapy. OMA significantly reduced asthma exacerbation rate by 80% (by 91% in VGR and by 65% in GR group) and the dose of OCS by 62% (by 76% in VGR and by 46% in GR). ACQ declined by 34% in the group (p=0.005), by 52% in VGR (p=0,01) and by 10% in GR(p=0,2). AQLQ grew in the whole group by 34%(p=0,03) and in VGR by 40%(p=0.01). In GR group the increase by 25% was insignificant. Conclusions: Omalizumab has shown high effectiveness in real-world Polish patients in reduction of asthma exacerbations and the dose of oral corticosteroids, improvement in asthma control and quality of life indicators.