Omalizumab in Children with Severe Allergic Asthma: The Italian Real- Life Experience

Abstract

Background: Anti-IgE treatment represents a major breakthrough in the therapeutic management of severe allergic asthma. To date, omalizumab is the only biological drug currently licensed as add-on therapy in children aged > 6 years with moderate-to-severe and severe allergic asthma uncontrolled after treatment with high dose of inhaled corticosteroids plus long-acting inhaled beta2-agonist. The clinical efficacy and safety of omalizumab treatment in the pediatric population has been extensively documented in specific trials and consistently expanded from real-life studies. Our aim is to describe the impact of omalizumab on asthma management, by reporting the results of the first Italian multicenter observational study conducted in children and adolescents with severe allergic asthma.Methods: The study was a 1-year real-life multicenter survey conducted in 13 pediatric allergy and pulmonology tertiary centers in Italy. All patients with confirmed severe allergic asthma from whom Omalizumab add-on treatment was initiated between 2007 and 2015 were included in the study.Results: Forty-seven patients with severe allergic asthma were included in the study. A significant reduction in the number of asthma exacerbations was observed during treatment with omalizumab, when compared with the previous year (1.03 vs 7.2 after 6 months (p<0.001) and 0.8 after 12 months (p<0.001), respectively). Hospital admissions were reduced by 96%. At 12 months, forced expiratory volume in 1 s improved and a corticosteroid sparing effect was observed.No serious adverse events were reported during the follow-up period of 12 months.Conclusion: The results of the first Italian multicenter observational study confirmed that omalizumab is an effective and safe add-on therapy in uncontrolled severe allergic asthma in children.

Omalizumab and mepolizumab in the landscape of biological therapy for severe asthma in children: how to choose?

“…It is also designed for children with documented severe asthma exacerbations, frequent daytime symptoms or night-time awakenings and, if aged 12 or above, reduced lung function (forced expiratory volume in the first second, FEV1, < 80%) [16]. Many studies show the safety and efficacy of omalizumab [16][17][18][19][20][21][22][23][24], which have been specifically demonstrated in pediatric patients through clinical trials or real-life experiences published in the literature [19,21,22,24]. Apart from the specific clinical indications for which it is prescribed, in the scientific literature there is much evidence showing that this biological drug has also proved effective in the treatment of seasonal asthmatic exacerbations during spring and autumn [25,26], in patients with total IgE values > 2000 kU/L [27] and even in the treatment of intrinsic severe asthma [28].…”

Current State and Future of Biologic Therapies in the Treatment of Asthma in Children

“…Omalizumab was administered subcutaneously every 2-4 weeks and dose was calculated based on manufacturer instructions (body weight and serum IgE dependent). [13][14][15][16][17][18][19] Pediatric data. Brodlie et al conducted a 16-week uncontrolled therapeutic trial of omalizumab in 34 consecutive children (aged 5-16 years) with oral corticosteroid (OCS)dependent asthma and noted that omalizuab use decreased median daily prednisolone requirements (median daily dose reduced from 20 to 5 mg, P < 0.0001), improved quality of life (P < 0.0001), and asthma control (P = 0.0001).…”

“…A 1-year real-life multicenter study of pediatric allergy and pulmonology tertiary centers in Italy noted a significant reduction in asthma exacerbations with omalizumab (P < 0.001) compared with the previous year, and a 96% reduction in hospitalizations. 19 Adolescent and adult experience. These results are consistent with studies including both adolescents (12 years and older) and adults, which have demonstrated omalizumab efficacy in improving asthma outcomes, including symptom scores, 20,21 quality of life, [22][23][24] asthma exacerbations, [21][22][23][24][25][26] emergency department (ED) visits and asthma-related hospitalizations, 21,23,25,27 ICS and rescue inhaler requirements, 28 and sputum eosinophil levels compared with placebo.…”

Severe asthma in children: Current goals and unmet needs

“…Several randomized controlled trials and “real‐life” studies established the efficacy and safety of omalizumab in pediatric patients aged 6 years and older . Overall, omalizumab was effective in reducing the rate of asthma exacerbations, the number of hospitalizations for acute asthma attacks, and the related need for OCS in severe asthmatic children, significantly improving asthma control and QoL .…”

“…Other biologic therapies, such as anti‐IL5 (mepolizumab and reslizumab) and IL‐4/13 (dupilumab) monoclonal antibodies, are approved for the treatment of severe eosinophilic asthma starting from 6 years of age, and varying by country . However, their approval in the pediatric population is mainly based on data generated in adults, while their clinical development plan in children is currently ongoing.…”