title: Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean "real-life" experience.
abstract: BACKGROUND
  Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists.
  
  
  OBJECTIVE
  Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational "real-life" study.
  
  
  METHODS
  Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids).
  
  
  RESULTS
  Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (-65% p = 0.0002 at 1 year, and -70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months (p = 0.017), 1 year (p = 0.029) and 4 years (p = 0.014) of omalizumab treatment.
  
  
  CONCLUSIONS
  This long-term "real-life" study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the "real-life" practice.
authors.affiliation: Department of Thoracic Medicine, University Hospital of Heraklion Crete and Medical School, University of Crete, Greece. tzortzaki@med.uoc.gr
authors.forename: Eleni G
authors.initials: EG
authors.lastname: Tzortzaki
authors.forename: Andreas
authors.initials: A
authors.lastname: Georgiou
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Kampas
authors.forename: Marinos
authors.initials: M
authors.lastname: Lemessios
authors.forename: Miltiadis
authors.initials: M
authors.lastname: Markatos
authors.forename: Tonia
authors.initials: T
authors.lastname: Adamidi
authors.forename: Katerina
authors.initials: K
authors.lastname: Samara
authors.forename: Georgia
authors.initials: G
authors.lastname: Skoula
authors.forename: Aggeliki
authors.initials: A
authors.lastname: Damianaki
authors.forename: Sophia
authors.initials: S
authors.lastname: Schiza
authors.forename: Nikos
authors.initials: N
authors.lastname: Tzanakis
authors.forename: Nikolaos M
authors.initials: NM
authors.lastname: Siafakas
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / 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* / Q000209:etiology; D015331:Cohort Studies; D003625:Data Collection; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D006967:Hypersensitivity / Q000150:complications; D008134:Long-Term Care; D008297:Male; D019083:Mediterranean Region; D008875:Middle Aged; D000069444:Omalizumab; D013147:Spirometry; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; C026408:anti-IgE antibodies; D000069444:Omalizumab