Quantitative risk reduction through peanut immunotherapy: Safety benefits of an increased threshold in Europe

The clinical relevance of increasing an allergic individual's peanut sensitivity threshold by immunotherapy, that is, eliciting dose (ED) to 300 or 1000 mg peanut protein, has not been previously characterized in a European population. In this study, we quantify the clinical benefits of an increased threshold of reaction following immunotherapy for the peanut-allergic individual.

Quantitative risk assessments incorporated numerous inputs to predict the risk of an allergic reaction after exposure to residual peanut protein in packaged foods. The three primary inputs for the risk assessment were the peanut-allergic individual's clinical threshold value, the amount of food consumed per eating occasion of selected packaged foods, and the concentration of peanut protein in the consumed product. Individual risk reductions were calculated for both children and adolescents-adults.

Using available consumption and packaged food contamination data, children reaching an ED of 300 mg (if initial ED ≤ 100 mg) or 1000 mg (if initial ED 300 mg) achieved >99.99% risk reduction. Adolescents-adults also achieved >99.99% risk reduction in all cases but one. Adolescents-adults who reached an ED of 300 mg (if initial ED ≤ 100 mg) achieved 99.3%-99.9% risk reduction when consuming ice cream.

It is concluded that an increase in threshold following immunotherapy which achieves an eliciting dose of 300 or 1000 mg peanut protein is clinically relevant for the European peanut-allergic population. Benefits of an increased threshold include a significant reduction in risk due to traces of peanut protein.