The New England Journal of MedicinePhase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

A phase 3, multicenter, double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of epicutaneous immunotherapy with a peanut patch in children aged 1 to 3 years with peanut allergy. No approved treatment for peanut allergy exists for children under 4 years old. Participants with confirmed peanut allergy were assigned to either receive the peanut patch or a placebo daily for 12 months. The primary endpoint was the treatment response measured by the eliciting dose of peanut protein at 12 months. The trial showed that 67.0% of children in the intervention group demonstrated a treatment response compared to 33.5% in the placebo group. Adverse events occurred in both groups, with serious adverse events and anaphylaxis observed more frequently in the intervention group. However, serious treatment-related adverse events were rare.

In conclusion, this trial demonstrated that epicutaneous immunotherapy with a peanut patch for 12 months was more effective than placebo in desensitizing children aged 1 to 3 years with peanut allergy and increasing their tolerance to peanut protein. Although adverse events were observed in both groups, serious treatment-related adverse events were uncommon. These findings suggest that epicutaneous immunotherapy may be a potential treatment option for young children with peanut allergy, but careful monitoring and management of adverse events are necessary. Further research is needed to fully understand the safety profile and long-term effects of this treatment approach.