title: Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma.
abstract: BACKGROUND
  Prevention of serious asthma exacerbations is an important therapeutic goal in patients with asthma.
  
  
  OBJECTIVE
  The purpose of this study was to investigate the effect of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody, on the rate of serious exacerbations during long-term therapy.
  
  
  METHODS
  A pooled analysis was completed of 3 multicenter, randomized, double-blind, placebo-controlled phase III studies with omalizumab in adults/adolescents aged > or =12 years (n = 1071) and in children aged 6 to 12 years (n = 334) who required treatment with inhaled corticosteroids for allergic asthma. Rates of serious asthma exacerbations were computed and compared between omalizumab- and placebo-treated patients. Serious exacerbations were those leading to unscheduled outpatient visits, emergency room treatment, or hospitalization during 1 year of treatment.
  
  
  RESULTS
  In all, 767 patients were treated with omalizumab (at least 0.016 mg/kg/IgE [IU/mL], administered subcutaneously every 4 weeks). Another 638 patients were treated with placebo. The rate of unscheduled, asthma-related outpatient visits was lower for the omalizumab-treated patients than for the placebo-treated patients (rate ratio [95% CI], 0.60 [0.44, 0.81]; P <.01), as were asthma-related emergency room visits (rate ratio [95% CI], 0.47 [0.24, 1.01]; P =.05). Importantly, hospitalizations for asthma were markedly reduced in patients receiving omalizumab (rate ratio [95% CI], 0.08 [0.00, 0.25]; P <.01).
  
  
  CONCLUSIONS
  Omalizumab reduces the rate of serious asthma exacerbations and the need for unscheduled outpatient visits, emergency room treatment, and hospitalization in patients with moderate-to-severe allergic asthma.
authors.affiliation: Allergy Research Foundation, Inc, Los Angeles, Calif 90025, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Corren
authors.forename: Thomas
authors.initials: T
authors.lastname: Casale
authors.forename: Yamo
authors.initials: Y
authors.lastname: Deniz
authors.forename: Mark
authors.initials: M
authors.lastname: Ashby
mesh_terms: D000293:Adolescent; D000328:Adult; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D000069444:Omalizumab; D012130:Respiratory Hypersensitivity / Q000188:drug therapy
chemical_list: D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab