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

被引：182

作者：

Brusselle, G. ^{[2
,3
]}

Michils, A. ^{[4
]}

Louis, R. ^{[5
,6
]}

Dupont, L. ^{[7
,8
]}

de Maele, B. Van ^{[9
]}

Delobbe, A. ^{[10
]}

Pilette, C. ^{[11
,12
]}

Lee, C. S. ^{[1
,13
,14
,15
]}

Gurdain, S. ^{[16
]}

Vancayzeele, S.

Lecomte, P. ^{[16
]}

Hermans, C. ^{[16
]}

MacDonald, K. ^{[1
,13
]}

Song, M. ^{[1
,13
,15
]}

Abraham, I. ^{[1
,13
,14
]}

机构：

[1] Matrix45, Earlysville, VA 22936 USA

[2] Ghent Univ Hosp, Dept Resp Med, B-9000 Ghent, Belgium

[3] Univ Ghent, B-9000 Ghent, Belgium

[4] Free Univ Brussels, Erasme Hosp, Dept Resp Med, B-1050 Brussels, Belgium

[5] Liege Univ Hosp, Dept Resp Med, Liege, Belgium

[6] Univ Liege, Liege, Belgium

[7] Katholieke Univ Leuven Hosp, Dept Resp Med, Leuven, Belgium

[8] Leuven Univ, Leuven, Belgium

[9] AZ St Jan Brugge Oostende Campus H Serruys, Dept Resp Med, Oostende, Belgium

[10] Citadelle Hosp, Dept Resp Med, Liege, Belgium

[11] Catholic Univ Louvain Hosp, Dept Resp Med, Louvain, Belgium

[12] Catholic Univ Louvain, B-3000 Louvain, Belgium

[13] Matrix45, Earlysville, VA USA

[14] Univ Arizona, Coll Pharm, Ctr Hlth Outcomes & Pharmacoecon Res, Tucson, AZ 85721 USA

[15] Univ Penn, Sch Nursing, Philadelphia, PA 19104 USA

[16] Novartis Pharmaceut, Vilvoorde, Belgium

来源：

RESPIRATORY MEDICINE | 2009年 / 103卷 / 11期

关键词：

Asthma; Allergic asthma; Severe asthma; Omalizumab; ANTI-IGE ANTIBODY; QUALITY-OF-LIFE; CONTROLLED-TRIALS; EXACERBATIONS; THERAPY;

D O I：

10.1016/j.rmed.2009.06.014

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

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, multi-center, 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 beta 2-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. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：1633 / 1642

页数：10

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