title: Effect of omalizumab as add-on therapy on asthma-related quality of life in severe allergic asthma: a Brazilian study (QUALITX).
abstract: OBJECTIVE
  To assess the impact of omalizumab as an add-on therapy to standard treatment with inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) on asthma-related quality of life (QoL) in patients with severe allergic asthma.
  
  
  METHODS
  This was a 20-week, randomized, open-label, study involving Brazilian patients (>12 years) with severe persistent allergic asthma inadequately controlled despite regular treatment with, at least, ICS (≥500 μg/day fluticasone or equivalent) + LABA. The primary objective was to assess the mean change from baseline in overall Asthma-related Quality of Life Questionnaire (AQLQ) score in omalizumab-treated patients compared with the control group. Secondary outcome measures included rescue medication use, incidence of asthma exacerbations, perception of treatment efficacy among patients, mean change from baseline in AQLQ score, and >1.5-point increase in overall AQLQ score.
  
  
  RESULTS
  In the omalizumab group, overall AQLQ score was 3.2 (0.9) (mean [SD]) at baseline and 4.4 (1.3) at week 20 versus 3.0 (1.0) at baseline and 3.0 (1.1) at week 20 in the control group. Mean change from baseline on overall AQLQ score at week 20 in the omalizumab group was 1.2 (0.2) versus 0 (0.1) in the control group, showing a significant increase in scores from baseline in the omalizumab group (p < .001). There was also a statistically significant difference (p < .001) in the number of patients who showed a >1.5-point increase from baseline in overall AQLQ score after 20 weeks, thus indicating a better QoL in the omalizumab group. There was no significant difference with respect to the use of rescue medication, incidence of asthma exacerbation, and adverse events between treatment groups. The global evaluation of treatment effectiveness was significantly better for omalizumab (p < .001).
  
  
  CONCLUSIONS
  Omalizumab was well tolerated and significantly improved the overall AQLQ score. Hence, it is a potential add-on therapy for severe persistent allergic asthma not controlled by standard prescribed treatment in Brazilian patients.
authors.affiliation: Chest Medicine, Health Science University, Porto Alegre, Brazil. arubin@terra.com.br
authors.forename: A S
authors.initials: AS
authors.lastname: Rubin
authors.forename: A
authors.initials: A
authors.lastname: Souza-Machado
authors.forename: M
authors.initials: M
authors.lastname: Andradre-Lima
authors.forename: F
authors.initials: F
authors.lastname: Ferreira
authors.forename: A
authors.initials: A
authors.lastname: Honda
authors.forename: T M
authors.initials: TM
authors.lastname: Matozo
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D058672:Adrenergic beta-2 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D001938:Brazil / Q000453:epidemiology; D004342:Drug Hypersensitivity / Q000150:complications / Q000453:epidemiology; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005512:Food Hypersensitivity / Q000150:complications / Q000453:epidemiology; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life; D044469:Racial Groups / Q000706:statistics & numerical data; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D058672:Adrenergic beta-2 Receptor Antagonists; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E