[HTML][HTML] Quantitative assessment of the safety benefits associated with increasing clinical peanut thresholds through immunotherapy
JL Baumert, SL Taylor, SJ Koppelman - The Journal of Allergy and Clinical …, 2018 - Elsevier
JL Baumert, SL Taylor, SJ Koppelman
The Journal of Allergy and Clinical Immunology: In Practice, 2018•ElsevierBackground Peanut immunotherapy studies are conducted with the aim to decrease the
sensitivity of patients to peanut exposure with the outcome evaluated by testing the
threshold for allergic response in a double-blind placebo-controlled food challenge. The
clinical relevance of increasing this threshold is not well characterized. Objective We aimed
to quantify the clinical benefit of an increased threshold for peanut-allergic patients. Methods
Quantitative risk assessment was performed by matching modeled exposure to peanut …
sensitivity of patients to peanut exposure with the outcome evaluated by testing the
threshold for allergic response in a double-blind placebo-controlled food challenge. The
clinical relevance of increasing this threshold is not well characterized. Objective We aimed
to quantify the clinical benefit of an increased threshold for peanut-allergic patients. Methods
Quantitative risk assessment was performed by matching modeled exposure to peanut …
Background
Peanut immunotherapy studies are conducted with the aim to decrease the sensitivity of patients to peanut exposure with the outcome evaluated by testing the threshold for allergic response in a double-blind placebo-controlled food challenge. The clinical relevance of increasing this threshold is not well characterized.
Objective
We aimed to quantify the clinical benefit of an increased threshold for peanut-allergic patients.
Methods
Quantitative risk assessment was performed by matching modeled exposure to peanut protein with individual threshold levels. Exposure was modeled by pairing US consumption data for various food product categories with potential contamination levels of peanut that have been demonstrated to be present on occasion in such food products. Cookies, ice cream, doughnuts/snack cakes, and snack chip mixes were considered in the risk assessment.
Results
Increasing the baseline threshold before immunotherapy from 100 mg or less peanut protein to 300 mg peanut protein postimmunotherapy reduces the risk of experiencing an allergic reaction by more than 95% for all 4 food product categories that may contain trace levels of peanut residue. Further increase in the threshold to 1000 mg of peanut protein had an additional quantitative benefit in risk reduction for all patients reacting to 300 mg or less at baseline.
Conclusions
We conclude that achieving thresholds of 300 mg and 1000 mg of peanut protein by peanut immunotherapy is clinically relevant, and that the risk for peanut-allergic patients who have achieved this increased threshold to experience an allergic reaction is reduced in a clinically meaningful way.
Elsevier