title: The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma.
abstract: BACKGROUND
  Patients with severe persistent asthma who are inadequately controlled despite treatment according to current asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and asthma-related mortality.
  
  
  METHODS
  Here, we pooled data from seven studies to determine the effect of omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on asthma exacerbations in patients with severe persistent asthma. Omalizumab was added to current asthma therapy and compared with placebo (in five double-blind studies) or with current asthma therapy alone (in two open-label studies). The studies included 4308 patients (2511 treated with omalizumab), 93% of whom had severe persistent asthma according to the Global Initiative for Asthma (GINA) 2002 classification. Using the Poisson regression model, results were calculated as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year.
  
  
  RESULTS
  Omalizumab significantly reduced the rate of asthma exacerbations by 38% (P < 0.0001 vs control) and the rate of total emergency visits by 47% (P < 0.0001 vs control). Analysis of demographic subgroups showed that the efficacy of omalizumab on asthma exacerbations was unaffected by patient age, gender, baseline serum IgE (split by median) or by 2- or 4-weekly dosing schedule, although benefit in absolute terms appeared to be greatest in patients with more severe asthma, defined by a lower value of percentage predicted forced expiratory volume in 1 s (FEV(1)) at baseline.
  
  
  CONCLUSIONS
  These results suggest that omalizumab may fulfil an important need in patients with severe persistent asthma, many of whom are not adequately controlled on current therapy.
authors.affiliation: Hôpital Arnaud de Villeneuve, Montpellier, France.
authors.forename: J
authors.initials: J
authors.lastname: Bousquet
authors.forename: P
authors.initials: P
authors.lastname: Cabrera
authors.forename: N
authors.initials: N
authors.lastname: Berkman
authors.forename: R
authors.initials: R
authors.lastname: Buhl
authors.forename: S
authors.initials: S
authors.lastname: Holgate
authors.forename: S
authors.initials: S
authors.lastname: Wenzel
authors.forename: H
authors.initials: H
authors.lastname: Fox
authors.forename: S
authors.initials: S
authors.lastname: Hedgecock
authors.forename: M
authors.initials: M
authors.lastname: Blogg
authors.forename: G Della
authors.initials: GD
authors.lastname: Cioppa
mesh_terms: D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000276:immunology* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D004632:Emergency Medical Services; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology*; D000069444:Omalizumab; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E