Oral Immunotherapy in Peanut-Allergic Adults Using Real-World Materials

Area of Science:

• Allergy and Immunology
• Clinical Trials
• Food Allergy Research

Background:

• Peanut oral immunotherapy (OIT) is effective for children but lacks evidence in adults.
• The Grown Up Peanut Immunotherapy (GUPI) study investigated OIT in adults.
• ClinicalTrials.gov identifier: NCT03648320.

Purpose of the Study:

• To evaluate the efficacy and safety of peanut OIT in adults with peanut allergy.
• To determine the proportion of adult participants tolerating a significant cumulative peanut protein dose after OIT.
• To compare mechanistic parameters between OIT and untreated control groups.

Main Methods:

• A phase II trial using a Simon's minimax two-stage design with real-world peanut products.
• Participants underwent baseline and exit double-blind placebo-controlled food challenges (DBPCFC).
• Daily OIT with 2-weekly updosing to a maintenance dose of 1000 mg peanut protein.

Main Results:

• 67% of adult participants achieved the maintenance dose and met the primary endpoint.
• The median tolerated peanut protein dose increased 100-fold, from 30 mg to 3000 mg (p < 0.0001).
• OIT improved Quality of Life (QoL) measures and showed suppression of skin prick test sizes and induced peanut-specific IgG.

Conclusions:

• Peanut OIT is an efficacious treatment for adults with peanut allergy.
• Further research is required to confirm efficacy and characterize safety in diverse adult subgroups.