Philippe Gevaert, Julia Eckl-Dorna, Rudolf Valenta, Renate Fröschl, Irene Steiner, Renata Kiss, Verena Niederberger, Thomas Perkmann, Katharina Gangl, Christian Lupinek, Peter Valent, Raffaela Campana, Andrea Mayer, Katharina Marth, Pia Gattinger, Regina Selb, Katharina Blatt, Jutta Gamper, Petra Zieglmayer
Background
Administration of the therapeutic anti-IgE antibody omalizumab to patients induces strong increases of IgE antibody levels.
Objective
To investigate the effect of intranasal administration of major birch pollen allergen Bet v 1, omalizumab or placebo on the levels of total and allergen-specific IgE in patients with birch pollen allergy.
Methods
Based on the fact that intranasal allergen application induces rises of systemic allergen-specific IgE we performed a double-blind placebo-controlled pilot trial in which birch pollen allergic subjects were challenged intranasally with omalizumab, placebo or birch pollen allergen Bet v 1. Total and allergen-specific IgE, IgG and basophil sensitivity were measured before and 8 weeks after challenge. For control purposes, total, allergen-specific IgE levels and omalizumab-IgE complexes as well as specific IgG levels were studied in subjects treated subcutaneously with either omalizumab or placebo. Effects of omalizumab on IgE production by IL-4/anti-CD40-treated PBMCs from allergic patients were studied in vitro.
Results
Intranasal challenge with Bet v 1 induced increases of Bet v 1-specific IgE levels by a median of 59.2% and this change differed significantly from the other treatment groups (p=0.016). No relevant change of allergen-specific and total IgE levels were observed in subjects challenged with omalizumab. Addition of omalizumab did not enhance IL-4/anti-CD40-induced IgE production in vitro. Significant rises in total IgE (mean IgE before: 131.83 kU/L to mean IgE after: 505.23 kU/L) and the presence of IgE-omalizumab complexes were observed after subcutaneous administration of omalizumab.
Conclusion
Intranasal administration of allergen induced rises of allergen-specific IgE levels whereas intranasal administration of omalizumab did not enhance systemic total or allergen-specific IgE levels.
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