Gian Luigi Marseglia1, Amelia Licari1, Maria Angela Tosca2, Giorgio Ciprandi3. 1. Department of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy. 2. Pediatric Allergy Center, Istituto Giannina Gaslini, Genoa, Italy. 3. Allergy Clinic, Casa di Cura Villa Montallegro, Genoa, Italy.
Abstract
Background: Severe asthma represents a significant challenge for children and adolescents. At the same time, it often places a burden on patients, caregivers, and society, mainly related to morbidity, mortality, and health care resources. In children and adolescents, severe asthma is mostly characterized by type 2 inflammation, which leads to bronchial eosinophilia that may be suppressed by corticosteroids. However, in this age group, a high dosage of inhaled corticosteroids combined with systemic corticosteroids sometimes results in unacceptable side effects, such as reduced growth velocity and reduced bone mineral density. Therefore, there is increasing and enthusiastic interest in today's biologics, including omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab. There is growing evidence that they may be effective and safe add-on options for children and adolescents. In 2009, omalizumab was approved by the European Medicines Agency as the first available therapeutic option for allergic asthma in patients as young as 6 years of age, followed by a similar approval by the U.S. Food and Drug Administration in 2016. Previously, omalizumab was marketed for this indication in patients ≥ age 12. Subsequent biologics, namely mepolizumab, reslizumab, and benralizumab, are IL-5 targeted agents that are presently approved in some countries for severe eosinophilic asthma starting at 6 years of age. Dupilumab is targeted against the IL-4 receptor α-chain, and it has been approved in the United States and the European Union as an add-on maintenance therapy in patients ≥12 years of age. Conclusion: This review presents the most recent evidence on approved biologics for the treatment of severe asthma and discusses the unmet needs and future perspective, focusing on the pediatric and adolescent age groups.
Background: Severe asthma represents a significant challenge for children and adolescents. At the same time, it often places a burden on patients, caregivers, and society, mainly related to morbidity, mortality, and health care resources. In children and adolescents, severe asthma is mostly characterized by type 2 inflammation, which leads to bronchial eosinophilia that may be suppressed by corticosteroids. However, in this age group, a high dosage of inhaled corticosteroids combined with systemic corticosteroids sometimes results in unacceptable side effects, such as reduced growth velocity and reduced bone mineral density. Therefore, there is increasing and enthusiastic interest in today's biologics, including omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab. There is growing evidence that they may be effective and safe add-on options for children and adolescents. In 2009, omalizumab was approved by the European Medicines Agency as the first available therapeutic option for allergic asthma in patients as young as 6 years of age, followed by a similar approval by the U.S. Food and Drug Administration in 2016. Previously, omalizumab was marketed for this indication in patients ≥ age 12. Subsequent biologics, namely mepolizumab, reslizumab, and benralizumab, are IL-5 targeted agents that are presently approved in some countries for severe eosinophilic asthma starting at 6 years of age. Dupilumab is targeted against the IL-4 receptor α-chain, and it has been approved in the United States and the European Union as an add-on maintenance therapy in patients ≥12 years of age. Conclusion: This review presents the most recent evidence on approved biologics for the treatment of severe asthma and discusses the unmet needs and future perspective, focusing on the pediatric and adolescent age groups.
Entities:
Keywords:
adolescents; allergy; biologics; children; eosinophils; severe asthma; type 2 inflammation
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