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Multicenter Study
. 2009 Nov;103(11):1633-42.
doi: 10.1016/j.rmed.2009.06.014. Epub 2009 Jul 19.

"Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study

G Brusselle  1 , 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, I Abraham
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Free article
Multicenter Study

"Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study

G Brusselle et al. Respir Med. 2009 Nov.
Free article

Abstract

Objective: To 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.

Methods: Effectiveness 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.

Results: The 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.

Conclusion: The 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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