title: Short and long-term quality of life and asthma control with omalizumab therapy in a real life setting in Portugal.
abstract: BACKGROUND
  The impact of severe asthma on patients' quality of life (QoL) has been previously demonstrated, as well the difficulties in controlling the disease. We aimed to evaluate the effect of omalizumab on QoL and asthma control, and its safety and tolerability in real-life conditions in Portugal.
  
  
  METHODS
  Prospective and open-label study in 15 adult patients with uncontrolled severe persistent allergic asthma on omalizumab treatment ≥16 weeks (w). The short (at 16w) and long-term (at 1 and 2 years) (y) effects of omalizumab were assessed through the Asthma Life Questionnaire (ALQ) and the Asthma Control Test (ACT). Other secondary outcomes were evaluated.
  
  
  RESULTS
  A significant reduction in ALQ total score (at 16w, p=0.002; at 1y, p=0.033 and at 2y, p=0.024), as well as in the 'non-scheduled medical visits' and the 'medication use' domains in both the short and long terms was observed. Regarding ACT, we verified a significant improvement in total score (at 16w, p=0.004; at 1y, p=0.004 and at 2y, p=0.008) and in almost all of the five individual questions. Asthma exacerbations and unscheduled health care visits were significantly decreased. There was a significant rise in lung function and a decrease in daily inhaled steroids dose. The most frequent adverse effects were headaches and nausea.
  
  
  CONCLUSIONS
  Omalizumab promoted a global benefit on QoL and asthma control outcomes. It also yielded a reduction in asthma exacerbations and unscheduled health care visits, a steroid-sparing effect, and an improvement in lung function. The drug was found to be generally safe and well-tolerated.
authors.affiliation: Serviço de Imunoalergologia, Centro Hospitalar de São João, E.P.E., Porto, Portugal. Electronic address: te_vieira@yahoo.com.br.
authors.forename: T
authors.initials: T
authors.lastname: Vieira
authors.affiliation: Serviço de Imunoalergologia, Centro Hospitalar de São João, E.P.E., Porto, Portugal.
authors.forename: J F
authors.initials: JF
authors.lastname: de Oliveira
authors.affiliation: Serviço de Imunoalergologia, Centro Hospitalar de São João, E.P.E., Porto, Portugal.
authors.forename: M
authors.initials: M
authors.lastname: da Graça Castel-Branco
mesh_terms: D000328:Adult; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011174:Portugal; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000069444:Omalizumab