Home-Based Therapy Achieves 100% Success Rate in Children with High-Threshold Peanut Allergy

In a phase 2 trial presented at the 2025 AAAAI/WAO Joint Congress, researchers reported that peanut oral immunotherapy (POIT) using store-purchased, home-measured peanut products achieved significantly higher rates of desensitization in children with high‐threshold peanut allergy compared with an avoidance strategy.

The study enrolled peanut‐sensitized children aged 4 to 14 years (IgE >0.35–50 kU/L) who reacted to cumulative peanut doses between 443 and 5043 mg. Seventy‐three participants meeting entry criteria were randomized 1:1 to either POIT or peanut avoidance. The POIT regimen consisted of a maintenance dose of approximately 3400 mg of peanut product administered using readily available, home‐measured peanut, with an oral food challenge (OFC) conducted up to 9043 mg of peanut protein.

The primary endpoint was defined as the proportion of participants tolerating a 2‐dose increase from baseline or 9043 mg. With pre‐specified imputation for missing values, the POIT group achieved a 100% success rate compared with 21.0% in the avoidance group (P<0.001). In the observed analysis, all 32 treated participants (100%) tolerated the 9043 mg challenge, versus 3 (10%) in the avoidance cohort. Among those on POIT, 86.7% maintained tolerance to 9043 mg on sustained unresponsiveness (SU) evaluation after 16 weeks of ad libitum ingestion followed by 8 weeks of avoidance, and by intention-to-treat analysis, 68.4% achieved SU/natural tolerance compared with 8.6% in the avoidance group (P<0.001).

Dr Scott H. Sicherer, MD, of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai, commented that the study uniquely addressed a subset of patients with high-threshold peanut allergy—often termed “bite safe”—who represent nearly half of the peanut-allergic population. He noted that the approach was safe, with treatment-related adverse events not exceeding grade 1, and may offer a cost-effective alternative for patients managed under careful allergist supervision.

Reference: Peanut Oral Immunotherapy Using Store-Bought, Home-Measured Products is Effective for Children with High-Threshold Peanut Allergy. News release. American Academy of Allergy, Asthma & Immunology. February 10, 2025. Accessed February 26, 2025. https://www.aaaai.org/about/news/news/2025/peanut