Omalizumab in children with uncontrolled allergic asthma: Review of clinical trial and real-world experience

Abstract

Asthma is one of the most common chronic diseases of childhood. Allergen sensitization and high frequencies of comorbid allergic diseases are characteristic of severe asthma in children. Omalizumab, an anti-IgE mAb, is the first targeted biologic therapeutic approved for the treatment of moderate-to-severe persistent allergic asthma (AA) that remains uncontrolled despite high-dose inhaled corticosteroids plus other controller medications. Since its initial licensing for use in adults and adolescents 12 years of age and older, the clinical efficacy, safety, and tolerability of omalizumab have been demonstrated in several published clinical trials in children aged 6 to less than 12 years with moderate-to-severe AA. These studies supported the approval of the pediatric indication (use in children aged ≥6 years) by the European Medicines Agency in 2009 and the US Food and Drug Administration in 2016. After this most recent change in licensing, we review the outcomes from clinical trials in children with persistent AA receiving omalizumab therapy and observational studies from the past 7 years of clinical experience in Europe. Data sources were identified by using PubMed in 2016. Guidelines and management recommendations and materials from the recent US Food and Drug Administration's Pediatric Advisory Committee meeting are also reviewed.

Pediatric asthma: An unmet need for more effective, focused treatments

“…Home administration is currently performed in France by a nurse or GP. However, the convenience of home use must be balanced with the risk of omalizumab‐associated anaphylaxis, a serious, albeit very rare occurrence, affecting 0.1%–0.2% of patients receiving this biologic agent …”

Care pathways for the selection of a biologic in severe asthma

“…Step 1 There are some simple situations: For patients who are allergic but not eosinophilic (level <300 per mm 3 ), omalizumab should be the first choice. For patients who are not allergic and have a high blood eosinophil count (mepolizumab ⩾300 per mm 3 , reslizumab ⩾400 per mm 3 ), anti-IL-5 mAbs should be considered first line [29]. For children aged 6 and <12 years of age that meet prescribing criteria, omalizumab is the only choice.…”

“…Age Omalizumab was approved in children above the age of 6 years by the EMA in 2009 and the FDA in 2016 [3]. The other existing biologics are not yet approved in children younger than 12 years.…”

“…Omalizumab, a monoclonal antibody (mAb) against immunoglobulin E (anti-IgE), was the first biologic developed for the treatment of severe allergic asthma and consistent results of randomised controlled trials (RCTs) [1] or real life trials [2] demonstrated a reduction of severe exacerbations in adults and children [3]. Some nonatopic asthma patients may also benefit from omalizumab [4].…”

Role of Regulatory T cells in Airway Inflammation in Asthma

“…ICS as anti-inflammatory agents are the first choice for management of asthma, but they are just controllers. Curing asthma is still difficult, although anti-IgE and anti-IL-5 therapies have shown results in severe asthma that are as good as other anti-allergic inflammatory agents [47][48][49]. Development of new treatment strategies utilizing Tregs could be useful in attenuating allergic reactions and achieving a cure for asthma.…”