Effectiveness and Safety Studies of Omalizumab in Children and Adolescents With Moderate-To-Severe Asthma

Abstract

Background Omalizumab is currently approved for the treatment of moderate-to-severe allergic asthma in patients 6 years and older. Objective To assess the effectiveness and safety of subcutaneous omalizumab as an add-on therapy option for moderate–severe allergic asthma in patients aged 6—20 years old. Methods The studies published from July, 1970 to May, 2021 were searched from the electronic databases which followed keywords: (“anti-IgE” OR “anti-immunoglobulin E” OR “anti-IgE antibody” OR “omalizumab” OR “rhuMAb-E25” OR “Xolair”) AND “asthma” AND (“child” OR “children” OR “adolescents” OR “youth” OR “teenager” OR “kids” OR “pediatric”). Thirteen studies were pooled to determine the effectiveness and safety of omalizumab. Efficacy endpoints were evaluated using a fixed-effects model or a random-effects model depending on heterogeneity. Safety endpoints were evaluated by odds ratio. Results Thirteen studies were included. In this meta-analysis, our results showed that fractional exhaled nitric oxide and asthma control test scores were significantly improved with omalizumab treatment. Serum immunoglobulin E was also decreased in children with moderate-to-severe asthma after treatment with omalizumab. The analysis found that there was no significant difference between pre-and post-treatment in forced expiratory volume in one second/ forced vital capacity ratio, forced expiratory flow between 25 and 75% of vital capacity, or FEV1. Overall, more adverse events occurred with omalizumab compared to placebo. However, the degree was mild to moderate. Conclusion This meta-analysis indicates that omalizumab is safe and effective to treat children and adolescents with moderate-to-severe asthma.

Biological treatments in childhood asthma

“…Furthermore, after 20 years of use, there are studies that document the effectiveness of omalizumab in real-life conditions in children with asthma, as they not only confirm the results of the above-mentioned clinical trials, but also show that omalizumab improves asthma control and lung function, reduces fractional exhaled nitric oxide (FeNO) levels, the use of corticosteroids, visits to the doctor, hospitalizations, visits to the emergency room, and so forth [14–19]. Several recent meta-analyses confirm these findings [20–22]. An additional advantage of anti-IgE treatment of severe asthma in children is the positive effect on other possible allergic comorbidities [23,24].…”

“…After 20 years of use, the most consistent evidence in terms of safety is that of omalizumab. Thus, apart from the studies specifically designed for this purpose [46][47][48][49], some recent meta-analyses conclude that, after several years of administration, omalizumab is a very well tolerated treatment [20][21][22]49,50]. A few cases of anaphylaxis have been reported in the general (adults, adolescents and children) population (0.2%) associated with the use of omalizumab [51].…”

Biological therapy of severe bronchial asthma in a child

“…Существующая биологическая терапия БА направлена против основных провоспалительных цитокинов или иммуноглобулинов Е (IgE), участвующих в формировании и персистенции эозинофильного Т2-воспаления у пациентов с тяжелой БА. В настоящее время проведено более 19 клинических исследований, посвященных изучению эффективности терапии омализумабом, показавших, что он является достаточно эффективным препаратом молекулярной направленности для пациентов с тяжелой формой БА [7,[9][10][11][12]. Однако тяжелая БА тоже гетерогенна, и не у всех пациентов протекает одинаково [6,11].…”

“…В настоящее время проведено более 19 клинических исследований, посвященных изучению эффективности терапии омализумабом, показавших, что он является достаточно эффективным препаратом молекулярной направленности для пациентов с тяжелой формой БА [7,[9][10][11][12]. Однако тяжелая БА тоже гетерогенна, и не у всех пациентов протекает одинаково [6,11]. Как свидетельствуют исследования, большая часть больных тяжелой БА относится к T2-эндотипу БА и имеет эозинофильное воспаление в слизистой нижних дыхательных путей -у 77% больных тяжелой БА присутствует фенотип атопической БА, ассоциированный с эозинофильным воспалением дыхательных путей [17][18][19].…”

“…Блокирование пути передачи сигналов ИЛ-4, ИЛ-13 дупилумабом у пациентов снижает концентрацию маркеров воспаления 2-го типа, включая иммуноглобулин Е, и множественные провоспалительные цитокины и хемокины. Дупилумаб показан детям с БА среднетяжелого и тяжелого течения в возрасте 12 лет и старше [3,[9][10][11].…”