Epicutaneous Immunotherapy Shows Potential as an Effective Treatment for Peanut Allergies in Toddlers

Peanut allergy is a common and potentially life-threatening condition, particularly in children. A recent phase 3 clinical trial published in the New England Journal of Medicine showed promising results for epicutaneous immunotherapy via a peanut patch in toddlers with peanut allergies.

The multicenter, double-blind, randomized, placebo-controlled trial included children aged 1 to 3 years with peanut allergies, which were confirmed through a double-blind, placebo-controlled food challenge. The researchers specifically targeted patients with an eliciting dose of <300 mg of peanut protein. These children were then assigned randomly in a 2:1 ratio to receive either the peanut patch or a placebo daily for 12 months.

The study’s primary objective was to measure the treatment response in terms of the eliciting dose of peanut protein at the end of the 12-month period. Safety was also a significant concern, and adverse events (AEs) were closely monitored throughout the trial.

Of the 362 patients who were enrolled in the study, 84.8% completed the trial. The results were striking, with 67.0% of children in the intervention group who received the peanut patch demonstrating a treatment response compared with 33.5% in the placebo group. These results translated to a risk difference of 33.4 percentage points, which was statistically significant (95% CI, 22.4-44.5; P<.001).

Melanie Makhija, MD, an associate professor of pediatrics at Northwestern University Feinberg School of Medicine and co-author of the study, said in a statement: “We were excited to contribute to this landmark study that carries so much promise for our young patients with peanut allergy.” She went on to say that “children who originally reacted to a small fraction of a peanut were able to tolerate the equivalent of 1 to 4 peanuts after completing the treatment course. This means that these children will be well protected from accidental exposure to peanuts.”

As expected, AEs were observed in both groups, with 100% of patients in the intervention group and 99.2% in the placebo group experiencing AEs during the study period. Serious AEs were reported in 8.6% of patients in the intervention group compared with 2.5% in the placebo group. Anaphylaxis, a severe allergic reaction, occurred in 7.8% of patients in the intervention group and 3.4% of those in the placebo group. However, it is worth noting that serious treatment-related AEs were minimal, occurring in only 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis was observed in 1.6% of patients in the intervention group and no patients in the placebo group.

The study’s findings suggest that epicutaneous immunotherapy with a peanut patch can effectively desensitize children aged 1 to 3 years with peanut allergies. Not only did the treatment result in an increased threshold for triggering allergic symptoms, but it also showed a significant improvement compared with placebo. While some AEs were reported, the overall safety profile of the treatment was deemed acceptable.

These results bring hope to parents and caregivers of young children with peanut allergies, as they show that epicutaneous immunotherapy is a potential treatment option where none previously existed for this age group. “Importantly, we found that the peanut patch was safe, with very low chances of a severe allergic reaction. This is terrific news for families of kids with peanut allergies,” Dr. Makhija remarked.