Harmonization of Terminology for Tolerated and Reactive Dose in Food Allergy Immunotherapy.

Abstract

Currently, there is no Food and Drug Administration-approved therapy for food allergy. Several new potential treatments are under investigation, including food allergen immunotherapy via various routes of administration, such as oral immunotherapy, epicutaneous immunotherapy, subcutaneous immunotherapy, and sublingual immunotherapy. The double-blind, placebo-controlled food challenge (DBPCFC) has traditionally been used for diagnostic purposes, but extrapolation of the specific terminology used in food allergy diagnosis to interpretation of efficacy in clinical trials is incongruent and difficult to apply. There is a need for standardization of the terminology used in food allergy clinical trials, because inconsistencies can lead to potential misinterpretation of end points. The reactive dose, previously referred to as the eliciting dose, is defined as the dose given that induces the onset of unequivocal allergic symptoms, or the dose that stops the challenge based on physician discretion. Conversely, the single highest tolerated dose is defined as the highest dose given during a food challenge that elicits either no symptoms or symptoms that do not meet stopping criteria per the study protocol. The evolving field of food allergy provides a novel opportunity to define those end points that are most meaningful for patients, which is fundamental for successful implementation, education, and safety.