• Henry Milgrom, Angel Fowler-Taylor, Carlos Fernandez Vidaurre, and Sumedha Jayawardene.
• Department of Pediatrics, University of Colorado Health Sciences Center, National Jewish Health, Denver, CO 80206, USA. milgromh@njhealth.org
• Curr Med Res Opin. 2011 Jan 1; 27 (1): 163169163-9.

ObjectiveThis pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma.Study DesignTwo 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.ResultsThe 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.ConclusionsOmalizumab 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.

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