Short summary

Food allergy is a common disease in childhood affecting up to 8% in westernized countries. About 30% of these children are allergic to more than one food. Currently, there is no curative treatment for food allergy. A few studies have shown Omalizumab to be a promising drug in the treatment of food allergy. Treatment with Omalizumab may not only increase the threshold for a food allergic reaction to occur but may also have positive effects on concomitant allergic asthma and/or allergic rhinitis.

Rationale

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food. Causative foods in childhood are most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions and allergies to peanut and tree nut are infrequently outgrown compared to food allergies to milk, egg and wheat. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed. At present, patients are recommended to avoid the offending food(s) and to carry rescue medication (adrenalin autoinjector). Still, the ever-present fear of a severe allergic reaction from accidental ingestion of the offending food has a significant impact on quality of life for the food allergic children and their families. 

Different immunotherapy approaches such as oral immunotherapy, sublingual immunotherapy and subcutaneous immunotherapy are currently being evaluated for single allergens, especially peanut. Immunotherapy in food allergy is, however, associated with frequent and sometimes severe side effects and long term efficacy has not been evaluated sufficiently. Some studies have used the combination of Omalizumab (anti-IgE) and oral immunotherapy for the treatment of food allergy. For children suffering from more than one food allergy, generic treatment concepts targeting all IgE mediated anaphylactic reactions independently of allergen, would potentially protect these children from food anaphylaxis. A few studies have shown Omalizumab to be a promising drug in the treatment of food allergy by increasing the allergen threshold eliciting an allergic reaction, thereby protecting the patients against severe reactions by accidental intake of small amounts of the offending food allergen. However, larger controlled studies are needed especially in children. 

Children with food allergy often suffer from concomitant atopic dermatitis, allergic rhinitis and asthma. Omalizumab was initially licensed for the treatment of severe allergic asthma and subsequently for chronic urticaria, but is known also to have a positive effect on allergic rhinitis. Therefore, treatment with Omalizumab may not only increase the threshold for a food allergic reaction to occur but may also have positive effects for concomitant allergic asthma and/or allergic rhinitis in some of these children.

Description of the cohort

Children between 6 and 18 years with a clinical diagnosis of food allergy.

Data and biological material

Allergy test such as skin prick test and blood test will be performed.

To evaluate the threshold, food challenges will be performed.

Severity of comorbidity (asthma, allergic rhinitis, atopic dermatitis) and Quality of Life related to food allergy will be monitored.

Collaborating researchers and departments

Hans Christian Andersen Children's Hospital, Odense University Hospital

• Susanne Halken, Professor, MD, DMSci

Publications associated with the project

Study results, positive, negative or inconclusive, will be published in international peer reviewed allergy journals.