Short summary

Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Currently, there is no cure for food allergy and the only prophylaxis and treatment is avoidance of the offending food and carrying a adrenaline autoinjection in case of an allergic reaction. A generic treatment that could prevent a anaphylactic reactions is therefore highly needed.

Rationale

Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Allergen immunotherapy is currently under investigation with peanut allergen both via the subcutaneous and oral route and will probably prove efficient in many patients. Treatment of peanut allergy will however only cover 5-10% of the eligible candidates for protection since also nuts, milk, egg, kernels, meat, wheat among others are well known triggers of food anaphylaxis. Development of specific tools for each allergy will be very costly and thus not be available in the near future. A generic treatment concept, covering all IgE mediated anaphylactic reactions would therefore be instrumental for protecting the patients from the potentially lethal reactions by accidental intake. Such a treatment could also be beneficial for patients with more than one food allergy and even in idiopathic anaphylaxis or patients with systemic mastocytosis. 

The level of specific IgE in serum may constitute a target point for preventive intervention. Levels of IgE in serum can be reduced by two different interventions; by plasmapheresis using IgE binding columns (> 90 % reduction of IgE)(Miltenyi Biotech GmbH) and by treatment with anti-IgE (Omalizumab [Xolair®]) (? 50 % reduction). A combination of initial immunoadsorption (plasmapheresis) followed by prolonged therapy with Omalizumab would theoretically maintain the reduced level.

The aim is to investigate if the combination treatment will increase the clinical threshold to the culprit food and thus prevent medical emergencies in patients with food anaphylaxis due to the reduction of specific IgE to the culprit food.

A proof-of-concept study will be performed in patients allergic to grass pollen and house dust mites to evaluate the efficacy of immunoadsorption alone by investigating changes in specific IgE levels and histamine release in wheals elicited by grass/dust mite allergens (Experiment #1).

Subsequently, food allergic patients will be included, and changes in threshold to the culprit during oral food challenges and changes in levels of specific IgE will be investigated (Experiment #2).  

Description of the cohort

Experiment #1: 6 male or female patients 18-70 years of age with verified allergy to grass and/or house dust mites and positive skin prick test and specific IgE for the culprit allergen.

Experiment #2: 10 male or female patients, 18-65 years of age with verified food allergy and positive skin prick test and specific IgE to the culprit food.

Data and biological material

Blood samples 

Skin prick test

Lung function 

Skin microdialysis eluate (only experiment #1)

Clinical data

Collaborating researchers and departments

Odense Research Center for Anaphylaxis (ORCA), Dept. of Dermatology and Allergy Center, Odense University Hospital

• Consultant Henrik Fomsgaard Kjær, PhD
• M.D., Line K. Tannert, PhD
• Professor Per Stahl Skov, PhD
• Professor Carsten Bindslev-Jensen, DmSci, PhD

Department of Clinical Immunology

• Professor Torben Barington, 
• Consultant Kjell Titlestad, PhD 

Miltenyi Biotech GmbH, Germany

• Dr. med. Thomas Schreiner
• Dr. med. Liane Preussner