Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
OBJECTIVE
This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma.


METHODS
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.
Department of Pediatrics, University of Colorado Health Sciences Center, National Jewish Health, Denver, CO 80206, USA. milgromh@njhealth.org
Henry
H
Milgrom
Angel
A
Fowler-Taylor
Carlos Fernandez
CF
Vidaurre
Sumedha
S
Jayawardene
D000465:Algorithms; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000209:etiology / Q000276:immunology; D002648:Child; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000009:adverse effects*; D008297:Male; D000069444:Omalizumab; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012720:Severity of Illness Index
D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; D000069444:Omalizumab; D007073:Immunoglobulin E