title: Omalizumab in patients with severe asthma: the XCLUSIVE study.
abstract: OBJECTIVE
  Although the efficacy and safety of omalizumab (OMA) in uncontrolled severe allergic asthma has been demonstrated in several randomised controlled trials (RCTs), information on the treatment in a practice-related setting is limited. Thus, the purpose of this prospective multi-centre study (XCLUSIVE) was to investigate the efficacy, compliance and utilisation of OMA therapy in real-life clinical practice in Germany.
  
  
  METHODS
  One hundred ninety-five asthmatic patients initiated on anti-Immunoglobulin E (IgE) IgE treatment were followed-up for 6 months. Forced expiratory volume in 1 s (FEV(1) ), exacerbation rate, days of absence, asthma symptoms [Asthma Control Questionnaire (ACQ)], a Global Evaluation of Treatment Effectiveness (GETE) and medication use were assessed.
  
  
  RESULTS
  Measured outcome variables improved after a 16-week treatment period with OMA (FEV(1) +13.7% predicted P < 0.05, exacerbation rate -74.9% P < 0.0001, days of absence -92.1% P < 0.001, ACQ -43.7% P < 0.0001). Investigators evaluated the effectiveness of OMA by GETE in 78.8% as excellent or good (responder), and in 12.6%/8.6% as moderate/poor or worse (non-responder). Responders demonstrated better improvement of FEV(1), exacerbation rate, days of absence, ACQ and reduction of oral corticosteroids compared with non-responders.
  
  
  CONCLUSIONS
  Results of effectiveness strongly suggest that the efficacy demonstrated in RCTs can be transposed to a clinical practice-related setting.
authors: Department of Internal Medicine II, University of Ulm Medical Center, Ulm, Germany. christian.schumann@uniklinik-ulm.de
authors: Christian
authors: C
authors: Schumann
authors: Cornelia
authors: C
authors: Kropf
authors: Thomas
authors: T
authors: Wibmer
authors: Stefan
authors: S
authors: Rüdiger
authors: Kathrin Magdalena
authors: KM
authors: Stoiber
authors: Antje
authors: A
authors: Thielen
authors: Wolfgang
authors: W
authors: Rottbauer
authors: Claus
authors: C
authors: Kroegel
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000175:diagnosis* / Q000188:drug therapy*; D002648:Child; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates; D058006:General Practice; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011446:Prospective Studies; D012129:Respiratory Function Tests; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab