Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children

William W. Busse, Wayne J. Morgan, Peter J. Gergen, Herman E. Mitchell, James E. Gern, Andrew H. Liu, Rebecca S. Gruchalla, Meyer Kattan, Stephen J. Teach, Jacqueline A. Pongracic, James F. Chmiel, Suzanne F. Steinbach, Agustin Calatroni, Alkis Togias, Katherine M. Thompson, Stanley J. Szefler, Christine A. Sorkness

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Abstract

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. (Funded by the National Institute of Allergy and Infectious Diseases and Novartis; ClinicalTrials.gov number, NCT00377572.)

Original languageEnglish (US)
Pages (from-to)1005-1015
Number of pages11
JournalNew England Journal of Medicine
Volume364
Issue number11
DOIs
StatePublished - Mar 17 2011

ASJC Scopus subject areas

  • Medicine(all)

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    Busse, W. W., Morgan, W. J., Gergen, P. J., Mitchell, H. E., Gern, J. E., Liu, A. H., Gruchalla, R. S., Kattan, M., Teach, S. J., Pongracic, J. A., Chmiel, J. F., Steinbach, S. F., Calatroni, A., Togias, A., Thompson, K. M., Szefler, S. J., & Sorkness, C. A. (2011). Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. New England Journal of Medicine, 364(11), 1005-1015. https://doi.org/10.1056/NEJMoa1009705