Elsevier

Respiratory Medicine

Volume 103, Issue 11, November 2009, Pages 1633-1642
Respiratory Medicine

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

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Summary

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.

Keywords

Asthma
Allergic asthma
Severe asthma
Omalizumab

Cited by (0)

Statement of originality: In the PERSIST study, we observed better physician-rated effectiveness, greater improvements in quality of life, greater reductions in rates of severe exacerbations, and greater reductions in healthcare utilization than previously reported in efficacy studies involving omalizumab in the treatment of severe persistent allergic asthma. Thus, under “real-life” heterogeneity in patients, clinical settings, and physician practices, omalizumab is effective as add-on therapy in the treatment of patients with persistent severe allergic asthma.