Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 364, Issue 11, Pages 1005-1015Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1009705
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Funding
- National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) [NO1-AI-25496, NO1-AI-25482]
- National Center for Research Resources, NIH [M01RR00533, 1UL1RR025771, M01RR00071, 1UL1RR024156, 5M01RR020359-040]
- Novartis Pharmaceuticals
- Dey Pharma
- Boehringer Ingelheim
- Teva
- Amgen
- Pfizer
- Genentech
- AstraZeneca
- GlaxoSmithKline
- MedImmune
- Novartis
- Ception
- Phadia
- Vertex
- Biota
- Centocor
- Synairgen
- Merck
- 3V BioSciences
- EraGen Biosciences
- Ross Abbott
- Sandoz
- ScheringPlough
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BACKGROUND Research has underscored the effects of exposure and sensitization to allergens on the severity of asthma in inner-city children. It has also revealed the limitations of environmental remediation and guidelines-based therapy in achieving greater disease control. METHODS We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for 60 weeks, and the primary outcome was symptoms of asthma. RESULTS Among 419 participants who underwent randomization (at which point 73% had moderate or severe disease), omalizumab as compared with placebo significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P<0.001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P<0.001). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists. CONCLUSIONS When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma.
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