title: Assessment of long-term omalizumab treatment in patients with severe allergic asthma long-term omalizumab treatment in severe asthma.
abstract: OBJECTIVE
  Several clinical studies have demonstrated the effectiveness of omalizumab in patients with severe allergic asthma but the treatment period has always been relatively short (4-12 months). In the literature, there are a few data about the long-term omalizumab therapy. We aimed to assess the long-term clinical and functional effectiveness of omalizumab treatment in severe allergic asthmatic patients,
  
  
  METHODS
  Medical records describing the patients' status before the start of treatment, and also having been registered at the end of 4th, 12th, and 36th months from the commencement of treatment, and at the last visit where the patient was evaluated were used for omalizumab effectiveness assessments. Twenty-six patients (female/male: 21/5) with severe allergic asthma, uncontrolled despite GINA 2006 Step 4 therapy, were included in the study. Effectiveness outcomes included spirometry measurements, level of asthma control measured by asthma control test (ACT), systemic glucocorticosteroid (sGCS) use, emergency room (ER) visits, and hospitalizations for severe exacerbations. In addition, the quality of life was assessed using the quality of life questionnaire AQLQ(S) before, 4, and 36 months after treatment,
  
  
  RESULTS
  The mean age was 47.6 ± 13.9 and duration of allergic asthma was 22.7 ± 10.1 years. Serum total IgE levels were 322.0 ± 178.1 IU/mL. Mean duration of omalizumab treatment was 40.81 ± 8.2 months. FEV1 improved significantly at all control points versus baseline (p < .05). The level of asthma control as evaluated by ACT improved significantly after treatment (p < .05). We determined significantly reduced numbers of exacerbation, emergency visits, hospitalizations, sGCS, and SABA use by the end of 36 months (p < .05). The proportion of patients with improvements larger than 1.5 points in AQLQ(S) total score was 80.7% at the 4th month and 96.1% at the 36th month of treatment,
  
  
  CONCLUSIONS
  This study showed that long-term therapy with omalizumab for up to 3 years was well tolerated with significant improvement both in symptoms and lung functions. Accordingly, long-term omalizumab treatment may be recommended for responders.
authors.affiliation: Department of Chest Diseases, Mersin University School of Medicine, Mersin, Turkey. eylemozgur@yahoo.com
authors.forename: Eylem Sercan
authors.initials: ES
authors.lastname: Özgür
authors.forename: Cengiz
authors.initials: C
authors.lastname: Özge
authors.forename: Ahmet
authors.initials: A
authors.lastname: Ïlvan
authors.forename: Sibel Atış
authors.initials: SA
authors.lastname: Naycı
mesh_terms: D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab