title: Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma.
abstract: OBJECTIVE
  To evaluate the long-term effects of the anti-IgE antibody omalizumab in children with asthma.
  
  
  METHODS
  This was a 28-week, double-blind, randomized, placebo-controlled trial with a 24-week open-label extension. In the core trial 225 children (ages 6 to 12 years) with moderate-to-severe allergic asthma requiring inhaled beclomethasone dipropionate (BDP) received omalizumab every 2 or 4 weeks, and 109 received placebo. BDP dosage was stable for weeks 1 to 16, then reduced during weeks 17 to 24 using strict safety criteria. The lowest dose for optimal asthma control was maintained for 4 more weeks. During the 24-week extension, all patients (n = 309) received open-label omalizumab in addition to other asthma medications. One-year safety data were analyzed.
  
  
  RESULTS
  The incidence of adverse events in patients treated with omalizumab for 52 weeks was similar to those treated for 28 weeks in the core trial, which was generally comparable with placebo. In the 52-week omalizumab group, upper respiratory tract infection and headache were the most frequently reported adverse events (47.1% and 42.7%, respectively). Eleven patients (4.9%) reported urticaria, which resolved spontaneously or with antihistamine, except for 1 patient who was discontinued because of severe urticaria. No anaphylactic reactions or adverse events suggestive of serum sickness or immune complex formation occurred. No anti-omalizumab antibodies were detected in any of the children. There is no evidence that new or more serious adverse events occur with long-term omalizumab treatment.
  
  
  CONCLUSIONS
  Long-term treatment with omalizumab is safe and well tolerated in children with allergic asthma.
authors.affiliation: Mission Viejo Medical Center, Mission Viejo, California, USA. weberger@uci.edu
authors.forename: William
authors.initials: W
authors.lastname: Berger
authors.forename: Niroo
authors.initials: N
authors.lastname: Gupta
authors.forename: Margaret
authors.initials: M
authors.lastname: McAlary
authors.forename: Angel
authors.initials: A
authors.lastname: Fowler-Taylor
mesh_terms: D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000097:blood / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007279:Injections, Subcutaneous; D008137:Longitudinal Studies; D008297:Male; D000069444:Omalizumab; D010976:Platelet Count
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C026408:anti-IgE antibodies; D000069444:Omalizumab; D007073:Immunoglobulin E; D001507:Beclomethasone