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Allergy and Asthma Clinic, Charité, Humboldt University Berlin, Germany
CORRESPONDENCE: G. Kunkel, Allergy and Asthma Clinic Charité, Virchow Klinikum, Humboldt University, Augustenburger Platz 1, 13353, Berlin, Germany. Fax: 49 30450565902. E-mail: gerald.hanf@charite.de
Keywords: allergic rhinitis, anti-imunoglobulin-E, omalizumab, rhuMAb-E25
Received: December 4, 2001
Accepted September 8, 2003
Elevated serum levels of antigen-specific immunoglobulin (Ig)E are often associated with allergic respiratory diseases. This parallel-group, randomised, double-blind, placebo-controlled trial was designed to study the influence of omalizumab on the early nasal response to allergen challenge reflected by symptom score and inflammatory marker levels in nasal lavage fluid (NAL).
A total of 23 patients with allergic rhinitis took part in the study, 11 were given placebo and omalizumab was administered subcutaneously in 12. Omalizumab or placebo were given at 2- or 4-week intervals based on a patient's body weight and IgE levels to a total dose of 0.016 mg·kg1·IgE1 (IU·mL1) every 4 weeks.
Compared to placebo, 16 weeks of treatment with omalizumab significantly inhibited allergen challenge-induced nasal symptoms (median symptom score 7.00.5 versus 7.07.0) and inhibited the increase of human serum albumin (median 15.30.12 mg·mL1 versus 8.219.7 mg·mL1) in the NAL after allergen challenge. Treatment with omalizumab induced a significant decrease in tumour necrosis factor-
These results indicate that subcutaneously administered monoclonal anti-immunoglobulin-E antibody, omalizumab, inhibits the nasal responses to allergen challenge of patients with allergic rhinitis. Omalizumab may provide a new strategy for the treatment of allergic rhinitis.
levels in basal NAL, but no change was seen for histamine.
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