Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma

Abstract

Background: Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003. Methods: We conducted a systematic review and meta-analysis of two critical (exacerbation rate, oral corticosteroid (OCS) treatment) and eight important clinical outcomes in children, adolescents and adults, and specifically searched papers for systematic assessment of severe asthma. Results: Adults: seven studies (n = 2159) ascertaining exacerbation rate showing a 37% (95% CI 21-50) reduction in favor of omalizumab, larger than the pre-specified minimal clinically important difference (MCID) of 25%. Only one open-label study (n = 82) was identified assessing the percentage of patients experiencing reduction of OCSmaintenance treatment showing a significantly greater decrease in the omalizumab group (− 45% vs. + 18.3%, p = 0.002). Children and adolescents: four studies (n = 1551) reported data on exacerbations (no meta-analysis conducted), showed overall improvements in exacerbation rate and some passed MCID. No OCS studies were identified. No included studies provided systematic assessment of severe asthma according to current guidelines. Conclusions: Omalizumab provides clinically relevant improvements in exacerbation rate among children, adolescents, and adults and in OCS-reduction among adults. New studies incorporating a guideline-approached definition of severe asthma are warranted.

Difficult and Severe Asthma in Children

“…Patients with higher levels of peripheral eosinophil count, exhaled nitric oxide (eNO), and serum periostin are more likely to respond to omalizumab [ 80 , 81 ]. Omalizumab provides clinically relevant improvements in exacerbation rate, lung function, and circulating eosinophil counts in children, adolescents and adults with moderate-to-severe uncontrolled asthma [ 82 , 83 ]. Mild systemic (pyrexia, headache, abdominal pain) and local (swelling, erythema, pain, pruritus in the injection side) adverse reactions are reported [ 84 ].…”

Clinical Experience with Anti-IgE Monoclonal Antibody (Omalizumab) in Pediatric Severe Allergic Asthma—A Romanian Perspective

“…The high incidence of allergy in pediatric asthma, and the increased levels of serum total IgE usually encountered in severe forms of the disease, are sound reasons for the use of anti-IgE therapy in children. Omalizumab, a subcutaneously administered humanized anti-IgE monoclonal antibody, has been approved as add-on therapy for patients with moderate to severe persistent allergic asthma that remains uncontrolled despite daily high-dose inhaled corticosteroids (ICS) plus inhaled long-acting beta-adrenoceptor agonist (LABA) treatment or other controller treatment, who have a positive skin prick test response or in vitro reactivity to a perennial aeroallergen [ 20 , 21 , 22 ]. Owing to the central role of IgE antibody in the pathophysiology of allergic disorders, Omalizumab was the first biological agent to be authorized for the treatment of severe allergic asthma in children.…”

The Burden of Childhood Asthma by Age Group, 1990-2019: A Systematic Analysis for Global Burden of Disease Study 2019 Data

“…Although inhaled corticosteroids can control the symptoms of asthma, some children with persistent asthma still experience severe complications and lung dysfunction [4]. Due to a lack of understanding of health care for childhood asthma, children with asthma may experience reduced treatment e cacy and incomplete control of lung damage [5]. Childhood asthma imposes the highest disability burden, causing almost 13.8 million days of absence from school in the United States in 2013.…”