title: Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study).
abstract: To describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS).
  
  
  
  A non-interventional, mixed methodology study, combining retrospective and prospective data collection for 12 months pre-omalizumab and post-omalizumab initiation, respectively.
  
  
  
  Data were collected in 22 UK NHS centres, including specialist centres and district general hospitals in the UK.
  
  
  
  258 adult patients (aged ≥16 years; 65% women) with severe persistent allergic asthma treated with omalizumab were recruited, of whom 218 (84.5%) completed the study.
  
  
  
  The primary outcome measure was change in mean daily dose of oral corticosteroids (OCS) between the 12-month pre-omalizumab and post-omalizumab initiation periods. A priori secondary outcome measures included response to treatment, changes in OCS dosing, asthma exacerbations, lung function, employment/education, patient-reported outcomes and hospital resource utilisation.
  
  
  
  The response rate to omalizumab at 16 weeks was 82.4%. Comparing pre-omalizumab and post-omalizumab periods, the mean (95% CIs) daily dose of OCS decreased by 1.61 (-2.41 to -0.80) mg/patient/day (p<0.001) and hospital exacerbations decreased by 0.97 (-1.19 to -0.75) exacerbations/patient (p<0.001). Compared with baseline, lung function, assessed by percentage of forced expiratory volume in 1 s, improved by 4.5 (2.7 to 6.3)% at 16 weeks (p<0.001; maintained at 12 months) and patient quality of life (Asthma Quality of Life Questionnaire) improved by 1.38 (1.18 to 1.58) points at 16 weeks (p<0.001, maintained at 12 months). 21/162 patients with complete employment data gained employment and 6 patients lost employment in the 12-month post-omalizumab period. The mean number of A&E visits, inpatient hospitalisations, outpatient visits (excluding for omalizumab) and number of bed days/patient decreased significantly (p<0.001) in the 12-month post-omalizumab period.
  
  
  
  These data support the beneficial effects of omalizumab on asthma-related outcomes, quality of life and resource utilisation in unselected patients treated in 'real-world' clinical practice.
authors: Manchester Academic Health Science Centre, The University of Manchester & University Hospital of South Manchester, Manchester, UK.
authors: Robert M
authors: RM
authors: Niven
authors: Department of Respiratory Medicine, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
authors: Dinesh
authors: D
authors: Saralaya
authors: Department of Respiratory Medicine, Gartnavel General Hospital, Glasgow, UK.
authors: Rekha
authors: R
authors: Chaudhuri
authors: Department of Respiratory Medicine, Plymouth Hospitals NHS Trust, Plymouth, UK.
authors: Matthew
authors: M
authors: Masoli
authors: Department of Respiratory Medicine, St James's University Hospital, Leeds, UK.
authors: Ian
authors: I
authors: Clifton
authors: Birmingham Regional Severe Asthma Service, Birmingham Heartlands Hospital, Birmingham, UK.
authors: Adel H
authors: AH
authors: Mansur
authors: Novartis Pharmaceuticals UK Ltd, Frimley, UK.
authors: Victoria
authors: V
authors: Hacking
authors: pH Associates, Marlow, UK.
authors: Susan
authors: S
authors: McLain-Smith
authors: Department of Asthma and Allergy, Royal Brompton Hospital, London, UK.
authors: Andrew
authors: A
authors: Menzies-Gow
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index; D012959:Socioeconomic Factors; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069444:Omalizumab
keywords: Severe asthma; corticosteroids; exacerbations; omalizumab