Peanut Oral Immunotherapy Is Safe and Effective in Toddlers in Large Placebo-Controlled Trial

About 2% of children in the United States are allergic to peanuts, and most will not outgrow this allergy. In addition, other research suggests that the immune system is more malleable during early childhood. Consistent with this idea, prior research showed that toddlers can succeed with peanut oral immunotherapy (OIT) — a regimen that builds tolerance through small amounts of the allergen consumed daily for months. However, the initial trial was small, was conducted at a single site, and had no placebo group.

In contrast, the Peanut Oral Immunotherapy in Children Trial (IMPACT) enrolled 146 children aged 1–3 years at five academic medical centers in the United States — the first placebo-controlled study of OIT in this younger age group.The trial was long and demanding for families.

Toddlers who reacted to minimal amounts of peanut protein (e.g. 500 mg) in an entry food challenge were randomized to receive daily peanut flour or oat flour placebo. After initial dose escalation (from 0.1 mg to 6 mg) and biweekly buildup to a 2000-mg target dose over the course of the first Year (by week 30), participants continued with 2000-mg daily maintenance dosing for over 2 years (through week 134) — at which point they underwent a food challenge with actual peanut protein. They then went off treatment for 26 weeks and had another food challenge almost 3 years after starting the trial (week 160).

After 2 years of treatment 71% were able to clearly take the 5000-mg peanut challenge. Of special interest even if individuals stopped the oral immunotherapy for 6 months, 21% could still tolerate 5000 mg of peanut protein.

Beyond the science, there are practical advantages to starting oral immunotherapy early as trying to convince a 9-year-old who's been petrified of peanuts for their whole life to start doing this every day is not an easy task, but introducing foods to a 1-2 year old , one could easily build a routine. Thus pediatricians are reconsidering introducing more foods earlier.

Oil immunotherapy presents another growing holistic approach to addressing allergic disorders specifically food allergy.