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

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, I. Abraham

Research output: Contribution to journalArticle

140 Scopus citations

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 β2-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 ≥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 ≥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.

Original languageEnglish (US)
Pages (from-to)1633-1642
Number of pages10
JournalRespiratory Medicine
Volume103
Issue number11
DOIs
StatePublished - Nov 1 2009

Keywords

  • Allergic asthma
  • Asthma
  • Omalizumab
  • Severe asthma

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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    Brusselle, G., Michils, A., Louis, R., Dupont, L., Van de Maele, B., Delobbe, A., Pilette, C., Lee, C. S., Gurdain, S., Vancayzeele, S., Lecomte, P., Hermans, C., MacDonald, K., Song, M., & Abraham, I. (2009). "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respiratory Medicine, 103(11), 1633-1642. https://doi.org/10.1016/j.rmed.2009.06.014