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.
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.