Abstract
BackgroundA national program for the treatment of severe allergic (IgE-dependent) asthma with omalizumab (OMA) was implemented in Poland in 2013. This observational study evaluated the effectiveness of the Polish OMA program and monitored asthma control after treatment discontinuation.MethodsIn the first year of the program, 53 patients (23 new/30 continuing treatment) received OMA in the Barlicki Hospital, Poland. Patients were evaluated at baseline and after 16 weeks of OMA treatment by spirometry, mean dose of inhaled corticosteroids (ICS) and oral corticosteroids (OCS), number of asthma exacerbations, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). OMA treatment responses were determined using the global effectiveness of treatment evaluation scale. Fourteen patients ceased OMA treatment following ≥36 months of therapy and entered follow up.ResultsAll patients treated with OMA de novo for at least 16 weeks had a decrease in asthma exacerbations and showed a good (15/16, 94 %) or an excellent (1/16, 6 %) response to treatment. We observed a reduction in OCS dose (≥5 mg/day) in 14/16 (88 %) patients. ACQ and AQLQ scores improved by ≥0.5 points in 15/16 (94 %) and 14/16 (88 %) patients, respectively. After OMA cessation, 11/14 (79 %) patients showed worsening of asthma control and severe exacerbations.ConclusionsPatients in the OMA program show significant benefits, including reduced use of OCS, improved asthma control and quality of life. After OMA discontinuation, frequent severe exacerbations were observed primarily in patients whose asthma was previously uncontrolled by high OCS doses.
Highlights
A national program for the treatment of severe allergic (IgE-dependent) asthma with omalizumab (OMA) was implemented in Poland in 2013
The mean inhaled corticosteroids (ICS) dose converted to beclomethasone tIgE total immunoglobulin E levels (CFC) (BDP-CFC) equivalent was 2900 mcg/day, and the mean oral corticosteroids (OCS) dose in prednisone equivalent was 16 mg/day
After OMA discontinuation, frequent severe exacerbations were observed primarily in patients whose asthma was previously uncontrolled by high OCS doses
Summary
A national program for the treatment of severe allergic (IgE-dependent) asthma with omalizumab (OMA) was implemented in Poland in 2013. This observational study evaluated the effectiveness of the Polish OMA program and monitored asthma control after treatment discontinuation. Omalizumab (OMA) is a biological drug recommended by Global Initiative for Asthma (GINA) experts for the therapy of patients with uncontrolled severe allergic (IgE-dependent) bronchial asthma [1]. The aims of the study were to determine the clinical effectiveness of the OMA treatment program after 16 weeks of therapy in patients receiving the drug for the first time, and to evaluate asthma control after discontinuation of OMA in patients who did not obtain
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