Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma

Curr Med Res Opin. 2011 Jan;27(1):163-9. doi: 10.1185/03007995.2010.539502. Epub 2010 Dec 2.


Objective: This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma.

Study design: Two double-blind, placebo-controlled studies in children (6 to < 12 years) with moderate-to-severe allergic asthma investigated the efficacy/safety of omalizumab. Children on optimized asthma care (inhaled corticosteroids ± other controller medications) were randomized (2:1) to omalizumab (75-375 mg sc, q2 or q4 wk) or placebo. Pooled safety findings from these trials are presented in this publication.

Results: The safety population included 926 children (omalizumab, n = 624; placebo, n = 302). Adverse events (AEs) were more frequently reported in the placebo (91.7%) than omalizumab (89.7%) group. The most common AEs were nasopharyngitis, upper respiratory tract infection and headache. Suspected treatment-related AEs included headache, erythema and urticaria; none of which were reported by ≥ 2% of patients receiving omalizumab. Serious AEs (SAEs) were reported by 3.4% and 6.6% of patients receiving omalizumab and placebo, respectively; the most common were appendicitis, pneumonia and bronchitis; no deaths were reported.

Conclusions: Omalizumab has an acceptable safety profile, with a risk of AEs similar to placebo. This, combined with its efficacy profile, suggests that omalizumab may provide an additional asthma management option for children (6 to < 12 years) uncontrolled with current therapy that follows established guidelines.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Anti-Asthmatic Agents / adverse effects
  • Anti-Asthmatic Agents / therapeutic use
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Asthma / drug therapy*
  • Asthma / etiology
  • Asthma / immunology
  • Child
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Female
  • Humans
  • Immunoglobulin E / adverse effects*
  • Male
  • Omalizumab
  • Placebos
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Severity of Illness Index


  • Anti-Asthmatic Agents
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Placebos
  • Omalizumab
  • Immunoglobulin E