Epicutaneous Immunotherapy patch may effectively manage peanut allergies among Toddlers

EPITOPE trial found that an epicutaneous immunotherapy patch having 250 ug peanut protein has shown a significant response, and there were very low treatment-related anaphylaxis and discontinuations among peanut-allergic children aged 1-3 years. The trial results were published in the journal Annals of Allergy, Asthma & Immunology. 

Peanut allergy is very common in children and there are no approved peanut allergy treatments that can be used for children <4 years old. Hence researchers conducted a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of epicutaneous immunotherapy with a patch containing 250 µg peanut protein among peanut-allergic children ages 1-3 years. 

In the EPITOPE trial, peanut-allergic children developing symptoms that met the stopping criteria during a double-blind, placebo-controlled food challenge (DBPCFC) were given an eliciting dose (ED) of ≤300 mg peanut protein. They were randomized for 2:1 to 12 months of daily treatment with the peanut patch or placebo patch. There were 244 participants in the peanut patch group and 118 participants in the placebo group with a median age of 2.5 years and nearly 68.8% were male. The primary outcome was the percent difference in responders between active and placebo, based on DBPCFC ED at baseline and 12 months. Treatment-emergent adverse event (TEAE) rate was used to assess the safety.