title: Omalizumab versus 'usual care': results from a naturalistic longitudinal study in routine care.
abstract: BACKGROUND
  It is unclear how far the superior efficacy of omalizumab, established in randomized controlled clinical trials of patients with severe allergic asthma (SAA), translates into routine practice and when compared to matched controls.
  
  
  METHODS
  New-onset omalizumab-treated (OT) patients with SAA (n = 53) were compared to a matched control group of usual-care (UC) patients (n = 53). Treatment and procedures were naturalistic. Subsequent to a baseline assessment, patients were followed up over at least 6 months with at least two follow-up assessments. Primary clinical outcomes were the number of asthma attacks, persistence of asthma symptoms and degree of control [asthma control test (ACT), Global Initiative for Asthma]. Secondary outcome criteria were quality of life (Euro-Qol 5D) and number of medications. For each outcome we compared within-group effects from baseline to 6-month follow-up as well as between-group effects.
  
  
  RESULTS
  OT patients showed significant improvements in number [effect size (ES) = 0.03] and frequency (ES = 0.04) of asthma attacks as well as asthma control (ES = 0.09), whereas controls revealed no significant improvements in these measures. Further improvements in the OT group were found for 'perceived control always' (ACT, p = 0.006), no impairment (ACT, p = 0.02), reduction of sickness days (p = 0.002) and number of medications needed (p = 0.001).
  
  
  CONCLUSIONS
  Substantial beneficial effects of omalizumab, similar to those observed in controlled trials and after marketing studies, were confirmed, particularly with regard to the reduction of asthma attacks, persistence of symptoms, asthma control and reduction of concomitant asthma medications. This study provides a tougher test and generalizable evidence for the effectiveness of omalizumab in routine care.
authors.affiliation: Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany. wittchen@psychologie.tu-dresden.de
authors.forename: H-U
authors.initials: HU
authors.lastname: Wittchen
authors.forename: S
authors.initials: S
authors.lastname: Mühlig
authors.forename: J
authors.initials: J
authors.lastname: Klotsche
authors.forename: R
authors.initials: R
authors.lastname: Buhl
authors.forename: P
authors.initials: P
authors.lastname: Kardos
authors.forename: T
authors.initials: T
authors.lastname: Ritz
authors.forename: O
authors.initials: O
authors.lastname: Riedel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab