title: The eXpeRience registry: the 'real-world' effectiveness of omalizumab in allergic asthma.
abstract: Omalizumab has demonstrated therapeutic benefits in controlled clinical trials. Evaluation of outcomes in real-world clinical practice is needed to provide a complete understanding of the benefits of omalizumab treatment. eXpeRience was a 2-year, international, single-arm, open-label, observational registry that evaluated real-world effectiveness, safety and use of omalizumab therapy in 943 patients with uncontrolled persistent allergic asthma. Effectiveness variables (physician's Global Evaluation of Treatment Effectiveness [GETE], and change from baseline in exacerbation rate, symptoms, rescue medication use, and oral corticosteroid [OCS] use) were evaluated at pre-specified time-points. Safety data were also recorded. By physician's GETE, 69.9% of patients were responders to omalizumab after 16 (±1) weeks. The proportion of patients with no clinically significant exacerbations increased from 6.8% during the 12-month pre-treatment period to 54.1% and 67.3% at Months 12 and 24, respectively. Symptoms and rescue medication use at Month 24 were reduced by >50% from baseline. Maintenance OCS use was lower at Month 24 (14.2%) compared with Month 12 (16.1%) and baseline (28.6%). Overall, omalizumab had an acceptable safety profile. The results from eXpeRience indicate that omalizumab was associated with improvements in outcomes in patients with uncontrolled persistent allergic asthma; these improvements were consistent with the results of clinical trials.
authors.affiliation: Department of Pulmonary Medicine, Sint Franciscus Gasthuis, Kleiweg 500, 3045 PM Rotterdam, The Netherlands. g.braunstahl@sfg.nl
authors.forename: G-J
authors.initials: GJ
authors.lastname: Braunstahl
authors.forename: C-W
authors.initials: CW
authors.lastname: Chen
authors.forename: R
authors.initials: R
authors.lastname: Maykut
authors.forename: P
authors.initials: P
authors.lastname: Georgiou
authors.forename: G
authors.initials: G
authors.lastname: Peachey
authors.forename: J
authors.initials: J
authors.lastname: Bruce
mesh_terms: D000041:Absenteeism; 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* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011788:Quality of Life; D012042:Registries; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab
keywords: Allergic asthma; Anti-immunoglobulin E; Asthma control; Exacerbations; Symptoms