Efficacy of two-year anti-IgE therapy in patients with severe allergic bronchial asthma in Sverdlovsk region

Abstract

Introduction. The study of omalizumab efficacy in patients with severe bronchial asthma (SA) in randomized clinical trials is limited to 52 weeks. In real clinical practice, patients can receive the drug for much longer.Aim. Evaluate the one-year and two-year efficacy of omalizumab in patients with SA in Sverdlovsk region.Material and methods. The study included patients (n = 54) with allergic and mixed SA from the registry of Sverdlovsk region. Omalizumab efficacy was assessed over 12 and 24 months of therapy by dynamics of asthma exacerbations frequency, the use of health care resources, the need for short-acting beta-agonists (SABA) and systemic glucocorticosteroids (SGCS), the level of asthma control according to ACT, and the quality of life according to AQLQ, FEV1 levels and peripheral blood eosinophils.Results. During 12 months of omalizumab therapy, the reduction in asthma exacerbation rate was 63.7% (from 2.01 ± 1.51 per patient per year to 0.73 ± 1.03) (p < 0.001), which was accompanied by a decrease in emergency calls and hospitalizations rates by 92.4 and 84.1%, respectively (p < 0.001). Improved asthma control (by ACT) from 9 (Q1-Q3: 7–13) to 20 points (Q1-Q3: 16–23); the proportion of patients with uncontrolled SA decreased from 97.4 to 48.7% (p < 0.001). The need for SABA decreased to 92.9% (p < 0.001). The proportion of patients on SGCS decreased from 60.5% to 15.8% (p < 0.001). The quality of life (AQLQ) significantly improved, FEV1 increased (p < 0.001), the number of eosinophils in peripheral blood decreased (p = 0.015). By the end of the second year of therapy, the trend of improvement in indicators of efficacy continued.Conclusions. During 1 year of therapy with omalizumab, patients with allergic SA experienced a significant decrease in the number of exacerbations and use of health care resources, improved quality of life and asthma control, reduced need for SABA and SGCS, and improved respiratory function. In patients treated with omalizumab for 2 years, there was a further improvement or stabilization of efficacy indicators.