Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey

Abstract

Omalizumab has been shown to reduce exacerbation rates in moderate to severe allergic asthma. Our aim was to evaluate omalizumab efficacy and safety in a real-life setting in severe asthmatic children.104 children (aged 6-18 years), followed up in paediatric pulmonary tertiary care centres, were included at the beginning of omalizumab treatment. Asthma control levels, exacerbations, inhaled corticosteroid dose, lung function and adverse events were evaluated over 1 year.Children were characterised by allergic sensitisation to three or more allergens (66%), high IgE levels (mean 1125 kU?L -1 ), high rate of exacerbations (4.4 per year) and healthcare use during the previous year, and high inhaled corticosteroid dose (mean 703 mg equivalent fluticasone per day). Asthma control levels defined as good, partial or poor, improved from 0%, 18% and 82% at entry to 53%, 30% and 17% at week 20, and to 67%, 25% and 8% at week 52, respectively (p,0.0001). Exacerbation and hospitalisation rates dropped by 72% and 88.5%, respectively. At 12 months, forced expiratory volume in 1 s improved by 4.9% (p50.023), and inhaled corticosteroid dose decreased by 30% (p,0.001). Six patients stopped omalizumab for related significant adverse events.Omalizumab improved asthma control in children with severe allergic asthma and was generally well tolerated. The observed benefit was greater than that reported in clinical trials. @ERSpublications Omalizumab improves asthma control in children with severe allergic asthma and is generally well tolerated

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

“…These results were similar to those observed in the global registry (4.9 to 0.6), Czech Anti-IgE Registry (CAR) and other real-life data with up to 9 years of follow-up [9,13,28,29,32,33]. Additionally, clinically meaningful improvements in asthma control (ACT; mean change from baseline of 4.3 units) and patient health-related quality of life (mini-AQLQ; mean change from baseline of 0.94 units) were also observed.…”

“…As an add-on treatment, omalizumab has been shown to improve long-term asthma control and lung function, and reduce the use of corticosteroids, rescue medication and frequency of exacerbations in patients with persistent allergic asthma [6][7][8]. Supporting the results from clinical studies, real-world studies conducted in various European countries also reported improvement in asthma control and quality of life of patients after treatment with omalizumab [9][10][11][12]. To strengthen the evidence for omalizumab, a 2-year, global, post-marketing observational registry (eXpeRience) was conducted [13,14].…”

The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry

“…Было зафиксировано уменьшение объема ежедневной базисной терапии: до начала терапии средняя доза ингаляционных глюкокорти-костероидов в пересчете на флутиказон составляла 575 мкг/сут (Me 500 [437,5; 750]), через 48 мес -492 мкг/ сут (Me 500 [250; 562,5]; p=0,066); сокращение количества обострений и потребности в применении короткодей-ствующих β 2 -агонистов -с 12 (Me 10,5 [9,75;13,25] [225; 375]. Asthma control test (ACT) before the start of the treatment was 14 points (Me 14 [12;17,5],24]; p=0,0017). The decrease of the amount of the daily therapy was demonstrated.…”

“…Цель исследования -проанализировать эффективность и безопасность длительной таргетной терапии омализумабом (более 4 лет) у детей с тяжелой персистирующей неконтролируемой бронхиальной астмой по данным электронной информационной базы данных клинических слу-чаев (регистра). (Me 14 [12;17,5],24]; p=0,0017). Было зафиксировано уменьшение объема ежедневной базисной терапии: до начала терапии средняя доза ингаляционных глюкокорти-костероидов в пересчете на флутиказон составляла 575 мкг/сут (Me 500 [437,5; 750]), через 48 мес -492 мкг/ сут (Me 500 [250; 562,5]; p=0,066); сокращение количества обострений и потребности в применении короткодей-ствующих β 2 -агонистов -с 12 (Me 10,5 [9,75;13,25] [225; 375].…”

“…При анализе исследований, включающих детей с тяже-лой бронхиальной астмой, для оценки эффективности омализумаба отмечается такая же тенденция [17][18][19]. Недостаточно данных длительного мониторинга (более 2 лет) у пациентов младше 18 лет.…”