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

Research output: Contribution to journalArticle

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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

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Asthma
Placebos
Guidelines
Young Adult
National Institute of Allergy and Infectious Diseases (U.S.)
Random Allocation
Allergens
Glucocorticoids
anti-IgE antibodies
Omalizumab
Therapeutics
Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Busse, W. W., Morgan, W. J., Gergen, P. J., Mitchell, H. E., Gern, J. E., Liu, A. H., ... 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

Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. / Busse, William W.; Morgan, Wayne J.; Gergen, Peter J.; Mitchell, Herman E.; Gern, James E.; Liu, Andrew H.; Gruchalla, Rebecca S.; Kattan, Meyer; Teach, Stephen J.; Pongracic, Jacqueline A.; Chmiel, James F.; Steinbach, Suzanne F.; Calatroni, Agustin; Togias, Alkis; Thompson, Katherine M.; Szefler, Stanley J.; Sorkness, Christine A.

In: New England Journal of Medicine, Vol. 364, No. 11, 17.03.2011, p. 1005-1015.

Research output: Contribution to journalArticle

Busse, WW, Morgan, WJ, Gergen, PJ, Mitchell, HE, Gern, JE, Liu, AH, Gruchalla, RS, Kattan, M, Teach, SJ, Pongracic, JA, Chmiel, JF, Steinbach, SF, Calatroni, A, Togias, A, Thompson, KM, Szefler, SJ & Sorkness, CA 2011, 'Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children', New England Journal of Medicine, vol. 364, no. 11, pp. 1005-1015. https://doi.org/10.1056/NEJMoa1009705
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. New England Journal of Medicine. 2011 Mar 17;364(11):1005-1015. https://doi.org/10.1056/NEJMoa1009705
Busse, William W. ; Morgan, Wayne J. ; Gergen, Peter J. ; Mitchell, Herman E. ; Gern, James E. ; Liu, Andrew H. ; Gruchalla, Rebecca S. ; Kattan, Meyer ; Teach, Stephen J. ; Pongracic, Jacqueline A. ; Chmiel, James F. ; Steinbach, Suzanne F. ; Calatroni, Agustin ; Togias, Alkis ; Thompson, Katherine M. ; Szefler, Stanley J. ; Sorkness, Christine A. / Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 11. pp. 1005-1015.
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AU - Gern, James E.

AU - Liu, Andrew H.

AU - Gruchalla, Rebecca S.

AU - Kattan, Meyer

AU - Teach, Stephen J.

AU - Pongracic, Jacqueline A.

AU - Chmiel, James F.

AU - Steinbach, Suzanne F.

AU - Calatroni, Agustin

AU - Togias, Alkis

AU - Thompson, Katherine M.

AU - Szefler, Stanley J.

AU - Sorkness, Christine A.

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N2 - 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.)

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