An Oral Food Challenge Is Required for Accurate Diagnosis of Peanut Allergy in Infants Prior to Oral Immunotherapy: Evaluation of the Allergy Development to an Accelerated Pathway to Tolerance Peanut Oral Immunotherapy Program.

Abstract

Oral immunotherapy (OIT) practices for food allergy vary globally. Whereas oral food challenges (OFCs) are not routinely performed before OIT, they can prevent unnecessary treatment. In 2024, the Allergy Development to an Accelerated Path to Tolerance (ADAPT) OIT program was established as the first nationally standardized model of care for treatment of peanut allergy. Threshold OFCs (TOFCs) were used to confirm peanut allergy and determine the OIT starting dose. We evaluated the diagnostic accuracy and safety of this approach before starting OIT across the 10 ADAPT public hospital sites. Infants aged less than 12 months with a history of Consortium for Food Allergy Research grade 1 to 2 reaction to peanut and sensitization (skin prick test result of 3 mm or greater or peanut/Ara h 2 specific IgE result 0.35 kUA/L or greater) were eligible. A TOFC involved seven escalating doses of 15-1,300 mg peanut protein). Data were collected by retrospective chart review. Between April 2024 and October 2025, we assessed 1,275 infants; 778 underwent TOFC (median age, 13 months). The TOFCs were positive in 65.2% (507 of 778), with median eliciting dose of 120 mg. Anaphylaxis occurred in 12.0% of positive OFCs (61 of 507; 7.8% overall). Median skin prick test and Ara h 2 specific IgE results were higher in positive versus negative TOFCs but did not predict the reaction threshold or severity. Among 394 infants commencing OIT, 97.5% (384 of 394) successfully initiated treatment at a dose below the TOFC-determined threshold. Within ADAPT, 34.8% of infants had negative TOFCs despite prior reactions and sensitization, enabling early delabeling. Although TOFCs carried an anaphylaxis risk, events were safely managed. Oral food challenge should be routinely considered in infant peanut allergy evaluation regardless of the proposed management strategy (immunotherapy or allergen avoidance).