title: Omalizumab improves asthma-related quality of life in patients with severe allergic asthma.
abstract: BACKGROUND
  We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled corticosteroid (ICS) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs.
  
  
  OBJECTIVE
  The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life (QOL).
  
  
  METHODS
  These analyses were part of a multicenter, 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of subcutaneous omalizumab (> or =0.016 mg/kg of IgE [in international unit per milliliter] per 4 weeks) in 525 adults with severe allergic asthma. A 16-week steroid-stable phase was followed by a 12-week steroid-reduction phase and a 24-week double-blind extension phase. The effect of treatment on asthma-related QOL was evaluated by using the Asthma Quality of Life Questionnaire (AQLQ) administered at baseline and at weeks 16, 28, and 52.
  
  
  RESULTS
  The 2 treatment groups were comparable in terms of baseline AQLQ scores. At weeks 16, 28, and 52, omalizumab-treated patients demonstrated statistically significant improvements across all AQLQ domains, as well as in overall score. Moreover, a greater proportion of patients receiving omalizumab achieved a clinically meaningful improvement in asthma-related QOL during each phase of the study. Greater than 50% of both patients and investigators rated treatment similarly with omalizumab as excellent or good compared with less than 40% of placebo recipients.
  
  
  CONCLUSIONS
  In patients requiring moderate-to-high doses of ICSs for severe allergic asthma, the measurably improved disease control afforded by add-on omalizumab therapy is paralleled by clinically meaningful improvements in asthma-related QOL.
authors.affiliation: National Allergy, Asthma and Urticaria Centers of Charleston, Charleston, South Carolina, USA.
authors.forename: Albert
authors.initials: A
authors.lastname: Finn
authors.forename: Gary
authors.initials: G
authors.lastname: Gross
authors.forename: Julius
authors.initials: J
authors.lastname: van Bavel
authors.forename: Theodore
authors.initials: T
authors.lastname: Lee
authors.forename: Hugh
authors.initials: H
authors.lastname: Windom
authors.forename: François
authors.initials: F
authors.lastname: Everhard
authors.forename: Angel
authors.initials: A
authors.lastname: Fowler-Taylor
authors.forename: Jeen
authors.initials: J
authors.lastname: Liu
authors.forename: Niroo
authors.initials: N
authors.lastname: Gupta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000503:physiopathology / Q000628:therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab