title: Does omalizumab make a difference to the real-life treatment of asthma exacerbations?: Results from a large cohort of patients with severe uncontrolled asthma.
abstract: BACKGROUND
  Omalizumab has been shown to decrease the risk of hospitalization or ED visits in patients with uncontrolled severe allergic asthma compared with placebo. This longitudinal study observed the conditions under which omalizumab is prescribed in real-life settings and assessed whether its use as an add-on therapy alongside standard treatments decreases the risk of severe asthmatic exacerbations.
  
  
  METHODS
  A cohort of adult patients with uncontrolled severe asthma despite optimal treatment with inhaled and oral corticosteroids and a long-acting b 2 -agonist but no treatment with omalizumab upon entry was assembled. Risk of hospitalization or ED visits for asthma exacerbation was assessed using the Andersen-Gill extension of the Cox model for repeated events, controlling for age, sex, smoking history, BMI, gastroesophageal reflux, allergic status, allergic rhinitis, treatment, and hospitalization or ED visits for asthma in the 2 months prior to omalizumab treatment.
  
  
  RESULTS
  Overall, 163 physicians recruited 767 patients, of whom 374 took omalizumab at least once (mean observation period, 20.4 months). Omalizumab use was associated with an adjusted relative risk of 0.57 (95% CI, 0.43-0.78) for hospitalization or ED visits for asthma. In users of omalizumab, the adjusted relative risk of hospitalization or ED visits for asthma during omalizumab treatment vs nontreatment periods was 0.40 (95% CI, 0.28-0.58).
  
  
  CONCLUSIONS
  Add-on omalizumab is associated with a significantly decreased risk of hospitalization or ED visits in patients with uncontrolled severe asthma in real-life practice.
authors.affiliation: LA-SER, Paris, France; Equipe d'accueil 'Pharmacoépidémiologie et Maladies Infectieuses', Institut Pasteur, Paris, France. Electronic address: Lamiae.Grimaldi@la-ser.com.
authors.forename: Lamiae
authors.initials: L
authors.lastname: Grimaldi-Bensouda
authors.affiliation: INSERM U744, Institut Pasteur de Lille, Lille, France.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Zureik
authors.affiliation: Service de Pneumologie A, Hôpital Bichat, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Aubier
authors.affiliation: Université Paris-Sud, Kremlin-Bicêtre, France; Assistance Publique-Hopitaux de Paris, Service de Pneumologie, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Humbert
authors.affiliation: Clinique de Pneumologie, Saint-Ouen, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Levy
authors.affiliation: Unité de Biostatistique, Centre Hospitalier Universitaire de Rouen, Rouen, France; INSERM U657, Institut Hospitalo-Universitaire de Recherche Biomédicale, Université de Rouen, Rouen, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Benichou
authors.affiliation: Université de Bordeaux, Bordeaux, France; INSERM U657, Bordeaux, France; Service de Pharmacologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Molimard
authors.affiliation: Department of Epidemiology, London School of Hygiene & Tropical Medicine, London, England; LA-SER Europe Ltd, London, England.
authors.forename: Lucien
authors.initials: L
authors.lastname: Abenhaim
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab