ANNALS OF CLINICAL AND ANALYTICAL MEDICINE, sa.17(3), ss.213-217, 2026 (ESCI)
Aim: Severe asthma affects 2–5% of children and often remains uncontrolled despite high-dose inhaled corticosteroids (ICS) and long-acting β₂-agonists. Omalizumab, an anti-IgE monoclonal antibody, is approved for patients aged ≥ 6 years, yet evidence in younger children remains limited. This study assessed the efficacy, safety, and treatment satisfaction of omalizumab in pediatric patients aged 4–17 years with severe allergic asthma, emphasizing preschoolers. Methods: A retrospective cohort of 21 children with GINA-defined severe asthma who received ≥ 9 months of omalizumab (May 2023–December 2024) was evaluated. Data on exacerbations, hospitalizations, systemic corticosteroid use, ICS dose, lung function (FEV₁, reversibility), and asthma control (ACT/C-ACT) were compared between baseline and month 9. Results: Median exacerbations decreased from 8 to 2 per 6 months (p < 0.01), hospitalizations from 2 to 1 (p < 0.001), and systemic steroid use from 18 to 3 days (p < 0.001). FEV₁ improved from 55% to 82% (p < 0.001), and bronchodilator reversibility declined from 16% to 5% (p = 0.009). The median ICS dose decreased from 500 mcg to 125 mcg (p < 0.001). ACT/C-ACT scores rose from 7 to 22 (p ≤ 0.03). Two preschoolers (ages 4–5) achieved complete symptom control without adverse effects. Conclusion: Omalizumab markedly improved control, lung function, and steroid dependence across pediatric ages, including preschoolers. These findings support the potential value of early biologic intervention in improving short-term disease control in children who do not respond to conventional therapy