• G Brusselle, A Michils, R Louis, L Dupont, B Van de Maele, A Delobbe, C Pilette, C S Lee, S Gurdain, S Vancayzeele, P Lecomte, C Hermans, K MacDonald, M Song, and I Abraham.
• Department of Respiratory Medicine, Ghent University Hospital and Ghent University, Belgium.
• Respir Med. 2009 Nov 1; 103 (11): 1633-42.

ObjectiveTo evaluate the 16- and 52-week effectiveness of add-on omalizumab treatment under real-life heterogeneity in patients, settings, and physicians in an open-label, multicenter, pharmaco-epidemiologic study of patients with severe persistent allergic asthma in Belgium.MethodsEffectiveness outcomes included improvement in 2005 global initiative for asthma (GINA) classification, physician-rated global evaluation of treatment effectiveness (GETE), quality of life (Juniper asthma-related quality of life (AQLQ) and European quality of life questionnaire 5 dimensions (EQ-5D)), and severe asthma exacerbations. Patients studied included both intent-to-treat and per-protocol populations.ResultsThe sample (n=158) had a mean age of 48.17+/-17.18 years, and a slight majority were female (53.8%). Despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists, all patients experienced frequent symptoms and had exacerbations in the past year. At 16 weeks, >82% had good/excellent GETE (P values <0.001), >82% had an improvement in total AQLQ scores of > or =0.5 points (P<0.001), and >91% were severe exacerbation-free (P<0.001). At 52 weeks, >72% had a good/excellent GETE rating (P<0.001), >84% had improvements in total AQLQ score of > or =0.5 points (P<0.001), >56% had minimally important improvements in EQ-5D utility scores (P=0.012), and >65% were severe exacerbation-free (P<0.001). Significant reductions in healthcare utilization compared to the one year prior to treatment were noted.ConclusionThe PERSIST study shows better physician-rated effectiveness, greater improvements in quality of life, greater reductions in exacerbation rates, and greater reductions in healthcare utilization than previously reported in efficacy studies. Under real-life conditions, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma.

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