Abstract
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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