“Evaluating primary endpoints in peanut immunotherapy clinical trials”

Publication date: Available online 24 October 2018

Source: Journal of Allergy and Clinical Immunology

Author(s): Pablo Rodríguez del Río, Carmelo Escudero, Silvia Sánchez-García, María Dolores Ibáñez, Brian P. Vickery

Abstract

Food immunotherapy has been the focus of several allergy research initiatives over the last decade. Though many questions remain unanswered, the evidence suggests that this treatment may be available in the near future outside clinical trials. Additionally, pharmaceutical companies, in light of promising early stage results, have shown interest in developing commercially available products, thus increasing the likelihood that new immunotherapy treatments will be introduced, especially for peanut allergy.

Given this optimistic scenario, and given the prospect of rigorously developed products for peanut allergy treatment, each allergist will need to understand the specificities of these treatments and their expected efficacy and adverse event profiles. It is thus imperative that allergists understand the differences in efficacy between the different management options as well as how the endpoints are measured in the relevant literature. However, given the significant heterogeneity detected among food immunotherapy trials, this task may not be as straightforward as desired.

This article aims to dissect how primary efficacy endpoints are defined and assessed in order to facilitate understanding of the design of these trials and the potential impact that this variation may have on the reported outcomes.

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