As there is currently no cure for food allergy, the focus of drug development has been on providing protection against accidental exposure reactions, with caregivers often expressing a desire for a “buffer” against accidental exposure reactions that involve minimal risk. Recent studies have aimed to quantitatively demonstrate the benefits of increasing an individual’s threshold to the foods to which they are allergic through immunotherapy. However, published quantitative analyses investigating the relative risk reduction in a food-allergic population receiving a specific investigational immunotherapeutic treatment for their allergies are lacking.
For a recent modeling analysis published in Annals of Allergy, Asthma & Immunology, my colleagues and I utilized three primary inputs to estimate the relative risk reduction upon accidental peanut consumption from peanut-contaminated package food products. The first was dose distribution data from the Phase III PEPITES EPIT (epicutaneous immunotherapy) study; the other two were peanut protein concentrations and consumption data for specific packaged products.
This modeling analysis estimated up to a 78.4% relative risk reduction of an allergic reaction due to accidental exposure from consuming peanut in specific packaged products for participants treated for 12 months with an investigational 250-μg EPIT patch, compared with no statistically significant change for those randomized to the placebo group. The clinical significance of this model and its correlation to clinical effect is not clear.
An important limitation is that exposure scenarios exist beyond the scope of our specific packaged food risk assessment. For example, restaurant or catered meals, meals prepared at home, and other unpackaged foods were not included because controlled research into potential exposure amounts outside of packaged foods is currently lacking. Studies into potential exposures due to shared cooking utensils and cooking equipment are ongoing. Additionally, the data from the PEPITES study used in this modeling is limited to 12 months of treatment. It should also be noted that EPIT for peanut allergy has not been approved for marketing, nor evaluated for safety and efficacy, by the FDA or any other health authority. However, our findings support the potential real-world clinical relevance of this investigational immunotherapy and its possible role as a future therapy for peanut-allergic children.
Rebecca Shover