Abstract

The management of severe asthma in children is challenging due to the risks associated with an uncontrolled disease progression, which significantly increases the likelihood of acute exacerbations, hospitalizations, and even adverse outcomes. In this case, targeted immunobiological agents, particularly omalizumab, may be used to improve disease control. Objective. This open-label prospective clinical study aimed to evaluate the efficacy and safety of omalizumab in children with uncontrolled persistent asthma in clinical practice. Patients and methods. The study included 82 children aged 6 to 18 years (mean age: 12.2 ± 1.4 years) with moderate to severe asthma uncontrolled with medium- or high-dose inhaled corticosteroids (ICS) in combination with long-acting beta-2-agonists (LABAs). Omalizumab was prescribed considering the level of IgE and body weight, and the frequency of administration was once a month. Follow-up duration was 12 months. Asthma control (frequency of exacerbations, need for systemic CS during exacerbations, volume of standard therapy) and adverse events were assessed at baseline and 12 months after the initiation of therapy with omalizumab. Results. After 12 months of omalizumab therapy, we revealed a significant reduction in the frequency of exacerbations by 67% (p < 0.005), including the number of exacerbations requiring systemic CS administration (by 75% from baseline, p < 0.001). There was also a reduction in the volume of standard therapy in 48% of patients and in the use of short-acting beta-2-agonists (SABAs), which was reflected in improved asthma control (the percentage of patients with controlled asthma increased from 0 to 42.6 and 65.8 after 3 and 6 months of therapy, respectively). Conclusion. Omalizumab significantly improves the course of severe asthma in patients with allergic phenotype. Key words: children, bronchial asthma, targeted immunobiologic therapy

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