"After three years, 82% of treated children achieved sustained unresponsiveness... vs. 12% in the avoidance group."
Peanut Oral Immunotherapy Shows Promise for Toddlers
A randomized controlled trial in Stockholm, Sweden, has evaluated the safety and effectiveness of slow up-dosing peanut oral immunotherapy with a low maintenance dose. The study involved 75 children aged 1-3 years with confirmed peanut allergy.
Trial Design
Children were assigned 2:1 to receive peanut oral immunotherapy or peanut avoidance. The immunotherapy protocol used dose escalation every 4-6 weeks to a maintenance dose of 285 mg of peanut protein. The full course of treatment lasted three years.
Key Results
After three years, 82% of treated children achieved sustained unresponsiveness—meaning they could tolerate peanut after 4-6 weeks of avoidance—compared to just 12% in the avoidance group.
- Treated children tolerated a median cumulative dose of 5000 mg peanut protein (equivalent to 70-80 peanuts), while the avoidance group tolerated only 3 mg.
- Severe reactions during the final challenge occurred in 2.4% of treated children vs. 25% in the avoidance group.
- Immune markers showed decreased peanut-specific IgE and increased IgG4 in treated children.
Safety and Adherence
"Out of over 43,000 doses, 0.7% were associated with adverse reactions, mostly mild."
Adverse reactions included oral itching, lip symptoms, eczema, and urticaria. Severe dose-related events occurred in 6 children, and epinephrine was used at home 3 times in 2 children due to dose-related reactions.
Adherence was strong: median missed doses were only 4.2% over three years. The dropout rate was 16% in the immunotherapy group and 20% in the avoidance group.
Limitations
The study was open-label, had a small sample size (n=75), relied on parent-reported adverse events, and had differing starting doses for follow-up challenges. Generalizability is limited to younger children sensitized to peanuts.