Estimated Risk Reduction to Packaged Food Reactions by Epicutaneous Immunotherapy (EPIT) for Peanut Allergy

To estimate the relative risk reduction (RRR) when consuming peanut-contaminated packaged food products in children treated with epicutaneous immunotherapy (EPIT) for 12 months versus placebo.

A double-blind, placebo-controlled Phase 3 study population of children (n = 356) treated with EPIT for 12 months with either a patch containing 250 μg peanut protein (n = 238) or a placebo patch (n = 118).

The probability of an allergic reaction to packaged food products was modeled using Monte Carlo simulations. Study-population threshold dose distributions were fitted from a recently described phase 3 clinical trial population. An interval-censoring survival analysis approach was used for food challenge data. Peanut protein concentrations were from European and North American packaged food retail surveys and four commonly eaten packaged food groups (cookies, doughnuts, ice cream, and salty snacks) previously indicated to have high risk for unintended allergen presence and a high rate of product recall were selected. Consumption data were obtained from American and Dutch national surveys.

The population treated with the 250-μg patch demonstrated a significantly increased dose-response distribution after 12 months of treatment, which resulted in a relative risk reduction of 73.2% to 78.4% when consuming peanut-contaminated packaged food products versus no statistically significant change in the placebo group.

This study estimates a substantial RRR for allergic reactions among peanut-allergic children after 12 months of EPIT with the 250-μg patch, supporting the potential real-world clinical relevance of this investigational immunotherapy and its possible role as a future therapy for peanut-allergic children.

This is the first study to investigate the quantitative risk reduction of a food allergic population receiving a specific immunotherapeutic treatment of allergies. Prior studies served only to measure changes in reaction threshold according to predefined clinical trial protocols. This study used sound statistical models and a variety of investigational values to simulate the impact of EPIT on risk of an allergic reaction caused by accidental exposures to peanuts in real world situations. Caregivers often express a desire for a treatment that involves minimal risk, which could “buffer” against reactions from accidental exposure. EPIT may eventually serve this utility and can help to provide hope to patients and their loved ones. This study was limited with regard to exposure scenarios beyond packaged food and was limited by duration of EPIT therapy, because it is possible that with longer duration of therapy, the 250 μg population would increase reaction threshold even further, thus experiencing even greater risk reduction over time.