TY - JOUR
T1 - "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma
T2 - The PERSIST study
AU - Brusselle, G.
AU - Michils, A.
AU - Louis, R.
AU - Dupont, L.
AU - Van de Maele, B.
AU - Delobbe, A.
AU - Pilette, C.
AU - Lee, C. S.
AU - Gurdain, S.
AU - Vancayzeele, S.
AU - Lecomte, P.
AU - Hermans, C.
AU - MacDonald, K.
AU - Song, M.
AU - Abraham, I.
PY - 2009/11
Y1 - 2009/11
N2 - 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.
AB - 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.
KW - Allergic asthma
KW - Asthma
KW - Omalizumab
KW - Severe asthma
UR - http://www.scopus.com/inward/record.url?scp=70349621577&partnerID=8YFLogxK
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U2 - 10.1016/j.rmed.2009.06.014
DO - 10.1016/j.rmed.2009.06.014
M3 - Article
C2 - 19619998
AN - SCOPUS:70349621577
SN - 0954-6111
VL - 103
SP - 1633
EP - 1642
JO - Respiratory Medicine
JF - Respiratory Medicine
IS - 11
ER -