title: Outcomes before and after treatment escalation to Global Initiative for Asthma steps 4 and 5 in severe asthma.
abstract: BACKGROUND
  Little is known about health outcomes in severe asthma reflected by Global Initiative for Asthma steps 4 and 5.
  
  
  OBJECTIVE
  To analyze control, risk, economic, and health resource use (HRU) outcomes associated with treatment escalation to Global Initiative for Asthma steps 4 and 5.
  
  
  METHODS
  This was a before-vs-after retrospective cohort study of patients (12-75 years old) with asthma newly initiated to omalizumab, high-intensity corticosteroids (HICS; ≥1,000 μg/day of inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; ≥500 to <1,000 μg/day of fluticasone equivalent) using 2002 to 2011 MarketScan data. Poisson regression was used to model HRU outcomes; Tobit regression was used to model medical expenditures.
  
  
  RESULTS
  Of 19,227 patients, 856 initiated omalizumab, 6,926 initiated HICS, and 11,445 initiated HDICS. Use of β-agonist increased for the HDICS and HICS cohorts and decreased for the omalizumab cohort; acute care visits and oral corticosteroid use decreased during follow-up for the HDICS and omalizumab cohorts. Annual health care expenditures, polypharmacy burden, and outpatient visits were high for all cohorts and increased in the follow-up year (baseline to follow-up; general health care expenditures: omalizumab $14,071 to $34,887, HICS $12,030 to $15,557, HDICS $7,570 to $9,826; annual number of asthma prescriptions: omalizumab 11.74 to 19.46, HICS 7.8 to 12.44, HDICS 5.17 to 9.69; outpatient visits: omalizumab 26.79 to 34.06, HICS 18.78 to 21.37, HDICS 15.06 to 16.64).
  
  
  CONCLUSIONS
  Omalizumab use was associated with improvements in risk and control accompanied by large increases in expenditures per HRU. Patients on HDICS and HICS showed improvements in risk but worsening control and increased expenditures per HRU. Innovations in disease management and available treatment options are needed to more optimally achieve treatment goals.
authors.affiliation: Regis University School of Pharmacy, Denver, Colorado. Electronic address: psulliva@regis.edu.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Sullivan
authors.affiliation: University of Colorado, Aurora, Colorado.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Campbell
authors.affiliation: University of Colorado, Aurora, Colorado; American University of Armenia, Yerevan, Armenia.
authors.forename: Vahram H
authors.initials: VH
authors.lastname: Ghushchyan
authors.affiliation: Amgen, Inc, Thousand Oaks, California.
authors.forename: Gary
authors.initials: G
authors.lastname: Globe
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000191:economics / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000191:economics / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D001993:Bronchodilator Agents / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D001993:Bronchodilator Agents; D000069444:Omalizumab; D000068298:Fluticasone