Abstract
Background: Asthma is the most common chronic disease affecting children, with a negative impact on their quality of life. Asthma is often associated with comorbid allergic diseases, and its severity may be modulated by immunoglobulin E (IgE)-mediated allergen sensitization. Omalizumab is a humanized monoclonal anti-IgE antibody, the first biological therapy approved to treat patients aged ≥6 years with severe allergic asthma. The primary objective of our study was to investigate the efficacy and safety of Omalizumab in Romanian children with severe allergic asthma. Methods: In this observational real-life study, 12 children and adolescents aged 6 to 18 years (mean 12.4 years) with severe allergic asthma received Omalizumab as an add-on treatment. Asthma control, exacerbations, lung function, and adverse events were evaluated at baseline and after the first year of treatment. Results: We observed general improvement in total asthma symptom scores and reduction in the rate of exacerbation of severe asthma. Omalizumab treatment was associated with improvement in the measures of lung function, and no serious adverse reactions were reported. FEV1 improved significantly after one year of treatment with Omalizumab [ΔFEV1 (% pred.) = 18.3], and [similarly, ΔMEF50 (%) = 25.8]. The mean severe exacerbation rate of asthma decreased from 4.1 ± 2.8 to 1.15 ± 0.78 (p < 0.0001) during the year of treatment with Omalizumab. Conclusions: This study showed that Omalizumab can be an effective and safe therapeutic option for Romanian children and adolescents with severe allergic asthma, providing clinically relevant information on asthma control and exacerbation rate in children and adolescents. The results demonstrated the positive effect of Omalizumab in young patients with asthma, starting from the first year of treatment.
Highlights
Asthma is defined as a chronic inflammatory disease of the lower respiratory tract; it affects between 1 and 18% of the general population, usually starting in early childhood [1,2,3].On average, of the global population, between 10 and 12% of children under the age of 6 or7 years, and 14% of adolescents between the ages of 7 and 14 years suffer from asthma [4,5].Up to 90% of childhood asthma has an allergic background and is associated with a personal or family history of other allergic diseases such as allergic rhinitis, atopic dermatitis, or food allergy
We have reported here a retrospective observational survey of 12 Romanian children and adolescents with severe allergic asthma, which demonstrated that they benefited from additional anti-immunoglobulin E (IgE) monoclonal antibodies (Omalizumab) therapy for high-level maintenance treatment
Understanding the benefits of Omalizumab treatment and the importance of adherence to treatment in the pediatric population may provide insights that may guide the management of Omalizumab in patients with asthma treated with this therapy
Summary
Asthma is defined as a chronic inflammatory disease of the lower respiratory tract; it affects between 1 and 18% of the general population, usually starting in early childhood [1,2,3].On average, of the global population, between 10 and 12% of children under the age of 6 or7 years, and 14% of adolescents between the ages of 7 and 14 years suffer from asthma [4,5].Up to 90% of childhood asthma has an allergic background and is associated with a personal or family history of other allergic diseases such as allergic rhinitis, atopic dermatitis, or food allergy. The primary objective of our study was to investigate the efficacy and safety of Omalizumab in Romanian children with severe allergic asthma. Methods: In this observational real-life study, 12 children and adolescents aged 6 to 18 years (mean 12.4 years) with severe allergic asthma received Omalizumab as an add-on treatment. Exacerbations, lung function, and adverse events were evaluated at baseline and after the first year of treatment. The mean severe exacerbation rate of asthma decreased from 4.1 ± 2.8 to 1.15 ± 0.78 (p < 0.0001) during the year of treatment with Omalizumab. Conclusions: This study showed that Omalizumab can be an effective and safe therapeutic option for Romanian children and adolescents with severe allergic asthma, providing clinically relevant information on asthma control and exacerbation rate in children and adolescents. The results demonstrated the positive effect of Omalizumab in young patients with asthma, starting from the first year of treatment
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