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Elucidation of the mechanism of SIT will also provide new tools to monitor efficacy. At present efficacy can only be monitored by double-blind placebo-controlled food challenge (DBPCFC). While the DBPCFC will always remain the primary read-out for establishing efficacy, it is not an appropriate tool for monitoring efficacy at many (early) time-points during treatment. At present, reliable early (composite) biomarkers for efficacy that correlate with the outcome of the DBPCFC are not available. In depth monitoring of humoral and cellular immune parameters will help identify such (early) biomarkers for efficacy.



In the context of this proposal we focus on IgE-mediated food hypersensitivity, hereafter referred to as food allergy. The only available treatment for food allergy is avoidance, in conjunction with rescue medication in case of accidental exposure. Hidden allergens in composite foods or unwanted contaminations and occasional poor adherence to dietary restrictions make avoidance difficult and ineffective. Most food allergies are chronic life-long diseases that are potentially life-threatening. It is the main cause of emergency hospital ward visits for anaphylaxis. Food allergy is estimated to affect around 10 million EU citizens, and the threat of severe anaphylaxis has great impact on the quality of life of patients and their relatives. A curative treatment for food allergy is the only way to change this situation. Allergen-specific immunotherapy (SIT) is the only treatment available that comes close to a cure by targeting the immunological basis of the disease. During classical SIT allergic patients receive monthly injections with allergen extract for three to five years. It is a successful treatment for insect venom allergies and for respiratory allergies like rhino-conjunctivitis to pollen and house dust mite. Despite that almost 95% of the market for treatment of allergic diseases is covered by symptomatic drugs. The burden of monthly injections for prolonged periods and the variable quality of products based on biological extracts provide the basis for the current niche position of SIT. For food allergy, SIT is not used at all. Attempts to treat food allergies by SIT have failed because anaphylactic side-effects were too numerous and severe.