title: Omalizumab therapy in severe asthma: experience from the Spanish registry--some new approaches.
abstract: OBJECTIVE
  The efficacy of omalizumab in severe asthma has been widely demonstrated. The main objective of this study was to evaluate the efficacy and tolerability of omalizumab in a real-life setting in Spain, particularly in those patients with immunoglobulin E (IgE) levels out of range.
  
  
  METHODS
  Totally 266 uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids (ICSs) plus long-acting β2-agonist (LABA) were recruited. Main efficacy outcomes were asthma exacerbation rate (AER), asthma control test (ACT), and global evaluation of treatment effectiveness (GETE).
  
  
  RESULTS
  AER was reduced from 3.6 (3.6) in previous year to 0.67 (1.2) at 4 months (p < .05) and to 1.04 (1.8) at 2 years (p < .05). ACT increased significantly from 14.3 (4.7) at baseline to 18.4 (4.4) at 4 months (p < .05) and to 20.3 (4.0) (p < .05) at 2 years. After 4 months, 74.6% of patients had reached a good or excellent rate on the GETE scale (p < .05). This rate continued increasing up to 81.6% at 2 years. These efficacy results were similar for patients with "off-label" IgE > 700 IU/ml. At follow-up, maintenance treatment with oral steroids was discontinued in a considerable number of patients: from 89 to 19 (p < .05). Omalizumab was discontinued because of lack of efficacy only in 28/266 (10.5%) patients. Overall, 30 patients (11.4%) reported adverse events. Severe adverse events were not observed.
  
  
  CONCLUSIONS
  This real-life study confirms that omalizumab is very efficacious and very well tolerated in patients with uncontrolled severe asthma. Results did not vary in the subgroup of patients with IgE levels >700 IU/ml.
authors.affiliation: Department of Pneumology and Respiratory Allergy, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain. mvennera@hotmail.com, cvennera@clinic.ub.es
authors.forename: María Del Carmen
authors.initials: Mdel C
authors.lastname: Vennera
authors.forename: Luis
authors.initials: L
authors.lastname: Pérez De Llano
authors.forename: Santiago
authors.initials: S
authors.lastname: Bardagí
authors.forename: Pilar
authors.initials: P
authors.lastname: Ausin
authors.forename: Carles
authors.initials: C
authors.lastname: Sanjuas
authors.forename: Héctor
authors.initials: H
authors.lastname: González
authors.forename: José A
authors.initials: JA
authors.lastname: Gullón
authors.forename: Eva
authors.initials: E
authors.lastname: Martínez-Moragón
authors.forename: José A
authors.initials: JA
authors.lastname: Carretero
authors.forename: Elisabet
authors.initials: E
authors.lastname: Vera
authors.forename: Juan F
authors.initials: JF
authors.lastname: Medina
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Alvarez
authors.forename: Luis M
authors.initials: LM
authors.lastname: Entrenas
authors.forename: Alicia
authors.initials: A
authors.lastname: Padilla
authors.forename: Rosa
authors.initials: R
authors.lastname: Irigaray
authors.forename: César
authors.initials: C
authors.lastname: Picado
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011358:Product Surveillance, Postmarketing; D012720:Severity of Illness Index; D012907:Smoking / Q000453:epidemiology; D013030:Spain / Q000453:epidemiology
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E