title: Omalizumab therapy for asthma patients with poor adherence to inhaled corticosteroid therapy.
abstract: BACKGROUND
  Omalizumab, an anti-IgE monoclonal antibody, is administered by injection once or twice monthly in offices and clinics. It offers a potential alternative intervention for patients with allergic asthma that is not well controlled because of recalcitrant poor adherence to inhaled corticosteroid therapy.
  
  
  OBJECTIVE
  To assess the effect of omalizumab therapy by measuring airway responsiveness to adenosine, a marker of allergic airway inflammation, and resource use.
  
  
  METHODS
  Patients (N = 17) aged 6 to 26 years (mean age, 16.4 years) with poorly controlled persistent allergic asthma, less than 50% adherence to inhaled corticosteroid therapy, a forced expiratory volume in 1 second (FEV1) of 60% predicted or higher, and adenosine provocation concentration that caused a decrease in FEV1 of 20% (PC20) of 60 mg/mL or less were randomized to receive 4 months of omalizumab or placebo in a double-blind, crossover trial with a 3- to 4-month washout between treatments. Patients were instructed to continue taking inhaled corticosteroids throughout the study. The PC20 was measured before and after each period.
  
  
  RESULTS
  Fifteen patients completed the study. The mean baseline PC20 was 14.1 mg/mL (95% CI, 10.8-18.4 mg/mL). The fold change PC20 was 0.9 (95% CI, 0.5-1.7) during placebo and 3.1 (95% CI, 1.6-6.2) during omalizumab treatment; the estimated ratio was 3.4 (95% CI, 1.2-9.3; P = .02). Six patients required one or more short courses of oral corticosteroids for asthma exacerbations during placebo, but none required this intervention during omalizumab. During the study, the median prescription refills for inhaled corticosteroids was 0.15 (95% CI, 0.00-0.33) canisters per month.
  
  
  CONCLUSIONS
  Omalizumab therapy is an alternative for patients with more severe poorly controlled asthma in whom adherence does not improve with conventional interventions.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00133042.
authors.affiliation: Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Florida; Pulmonary Division, Department of Pediatrics, University of Florida, Gainesville, Florida. Electronic address: hendeles@cop.ufl.edu.
authors.forename: Leslie
authors.initials: L
authors.lastname: Hendeles
authors.affiliation: Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Florida.
authors.forename: Yasmeen R
authors.initials: YR
authors.lastname: Khan
authors.affiliation: Division of Biostatistics, Department of Epidemiology and Health Policy Research, College of Medicine, University of Florida, Gainesville, Florida.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Shuster
authors.affiliation: Pulmonary Division, Department of Pediatrics, University of Florida, Gainesville, Florida.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Chesrown
authors.affiliation: Pulmonary Division, Department of Pediatrics, University of Florida, Gainesville, Florida.
authors.forename: Mutasim
authors.initials: M
authors.lastname: Abu-Hasan
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; 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*; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D000069444:Omalizumab; D014481:United States; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab