Source: Annual Congress 2002 - The development of allergic sensitization / asthma in children
Disease area: Airway diseases

Abstract

Tolerability Assessment of a recombinant humanized monoclonal anti-IgE antibody (Omalizumab) as a treatment for seasonal allergic rhinitis Immune responses mediated by IgE are important in the pathogenesis of seasonal allergic rhinitis. A recombinant humanized monoclonal antibody (omalizumab) forms complexes with free IgE and blocks interaction of IgE with mast cells and basophils. We studied the tolerability of subcutaneously administered omalizumab in combination with specific immune therapy (SIT) versus SIT alone in a randomized, double blind, placebo controlled multicenter study. The population was restricted to 219 patients 6-17 years of age who suffer from symptoms of seasonal allergic rhinitis due to birch and grass pollen. During a 12 week double blind period patients received SIT titration either for grass or birch pollen allergy on a weekly basis. This was followed by a 24 week period in which patients were randomly assigned to additionally receive either omalizumab or placebo. A total dose of 100-375 mg omalizumab per injection was selected depending on patients¿ IgE levels and body weight. We documented local reactions like erythema in 80% of the treatment group versus 66%, edema in 68% versus 65%, induration in 50% versus 40%, pain in 23% versus 18%, reduced mobility in 3% versus 1,5%. In both groups the incidence of adverse events was equivalent. We documented no major serious adverse events. These data show that omalizumab was well tolerated in this patient population.

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Citations should be made in the following way:
S. Heck, S. Stenglein, J. Brauburger, W. Kamin (Tübingen, Nuremberg, Mainz, Germany). Tolerability assessment of a recombinant humanized monoclonal anti-IgE antibody (omalizumab) as a treatment for seasonal allergic rhinitis. Eur Respir J 2002; 20: Suppl. 38, 784

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