Abstract

IgE-mediated food allergies are caused by adverse immunologic responses to food proteins. Allergic reactions may present locally in different tissues such as skin, gastrointestinal and respiratory tract and may result is systemic life-threatening reactions. During the last decades, the prevalence of food allergies has significantly increased throughout the world, and considerable efforts have been made to develop curative therapies. Food allergen immunotherapy is a promising therapeutic approach for food allergies that is based on the administration of increasing doses of culprit food extracts, or purified, and sometime modified food allergens. Different routes of administration for food allergen immunotherapy including oral, sublingual, epicutaneous and subcutaneous regimens are being evaluated. Although a wealth of data from clinical food allergen immunotherapy trials has been obtained, a lack of consistency in assessed clinical and immunological outcome measures presents a major hurdle for evaluating these new treatments. Coordinated efforts are needed to establish standardized outcome measures to be applied in food allergy immunotherapy studies, allowing for better harmonization of data and setting the standards for the future research. Several immunological parameters have been measured in food allergen immunotherapy, including allergen-specific immunoglobulin levels, basophil activation, cytokines, and other soluble biomarkers, T cell and B cell responses and skin prick tests. In this review we discuss different immunological parameters and assess their applicability as potential outcome measures for food allergen immunotherapy that may be included in such a standardized set of outcome measures.

Highlights

  • Food allergy (FA) affects a large number of children and adults throughout the world, with more than 170 foods being reported to cause food-induced allergic reactions

  • Administration of omalizumab permitted a safe and effective desensitization treatment in these patients, 60% of the cow’s milk (CM) treated patients and 33% of the egg allergic patients relapsed after omalizumab suspension

  • In the context of FAAIT trials, it is important to distinguish between the two major objectives of immunological outcome measurements: 1) To identify outcome measures that have predictive value for the probability of successful Allergen-specific immunotherapy (AIT) that can be assessed at baseline

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Summary

Introduction

Food allergy (FA) affects a large number of children and adults throughout the world, with more than 170 foods being reported to cause food-induced allergic reactions. Allergen-specific immunotherapy (AIT) is a treatment option for immunoglobulin E- (IgE) mediated allergic diseases, including FA. Food allergen immunotherapy (FA-AIT) involves administration of increasing doses of a specific food until achievement of maintenance dosage [1]. Researchers and clinicians have focused on four major application routes of AIT, namely oral immunotherapy (OIT), sublingual immunotherapy (SLIT), subcutaneous immunotherapy (SCIT) and epicutaneous immunotherapy (EPIT) for the treatment of food allergies. Different routes and/or doses of AIT delivery results in similar immunologic changes [3, 4]. Before, during and after FA-AIT, an oral food challenge (OFC), either in open or double-blind placebo-controlled (DBPCFC) format, can be used to assess the allergen reactivity threshold and functional tolerance [7]. The cellular and molecular mechanisms that determine successful change in threshold and/or sustained unresponsiveness (SU) following long-term AIT in patients with FA are not fully understood, and FA-AIT is often

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