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Published ahead of print on June 1, 2004, doi:10.1164/rccm.200312-1651OC

Am. J. Respir. Crit. Care Med., Volume 170, Number 6, September 2004, 583-593

A more recent version of this article appeared on September 15, 2004
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Submitted on December 4, 2003
Accepted on May 19, 2004

The Effects of Anti-IgE (Omalizumab) on Airways Inflammation in Allergic Asthma

Ratko Djukanovic1*, Susan J Wilson1, Monica Kraft2, Nizar N Jarjour3, Mark Steel1, K. Fan Chung4, Weibin Bao5, Angel Fowler-Taylor5, John Matthews6, William W Busse3, Stephen T Holgate1, and John V Fahy7

1 Division of Infection, Inflammation and Repair, University of Southampton, Southampton, United Kingdom, 2 National Jewish Center, Denver, CO, USA, 3 University of Wisconsin Hospital and Clinics, Madison, WI, USA, 4 Imperial College, London, United Kingdom, 5 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 6 Novartis Horsham Research Centre, Horsham, United Kingdom, 7 University of California, San Francisco, CA, USA

* To whom correspondence should be addressed. E-mail: rd1{at}soton.ac.uk.

IgE plays an important role in allergic asthma. We hypothesized that reducing IgE in the airway mucosa would reduce airway inflammation. Forty-five mild to moderate persistent asthmatics with sputum eosinophilia >= 2% were treated with humanized monoclonal antibody against IgE (omalizumab) (n = 22) or placebo (n = 23) for 16 weeks. Outcomes included inflammatory cells in induced sputum and bronchial biopsies, and methacholine responsiveness. Treatment with omalizumab resulted in marked reduction of serum IgE and a reduction of IgE+ cells in the airway mucosa. The mean percentage sputum eosinophil count decreased significantly (p < 0.001) from 6.6% to 1.7% in the omalizumab group, a reduction significantly (p = 0.05) greater than with placebo (8.5% to 7.0%). This was associated with a significant reduction in tissue eosinophils, Fc{epsilon}RI+ cells, CD3+, CD4+ and CD8+ T lymphocytes, B lymphocytes, and cells staining for IL-4+ but not with improvement in airway hyperresponsiveness to methacholine. This study shows anti-inflammatory effects of omalizumab treatment and provides clues for mechanisms whereby omalizumab reduces asthma exacerbations and other asthma outcomes in more severe asthma. The lack of effect of omalizumab on methacholine responsiveness suggests that IgE or eosinophils may not be causally linked to airway hyperresponsiveness to methacholine in mild to moderate asthma.
Key words: eosinophils, IL-4, FcepsilonRI




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