IMPACT-PLuS follow-up found 80% of children treated with early-life peanut oral immunotherapy remained peanut tolerant 8 to 11 years later.
IMPACT-PLuS, a long-term follow-up of the Immune Tolerance Network's IMPACT trial, found 80% of children treated with
Most food OIT trials report outcomes measured in months, leaving limited data on what happens to desensitization or remission once children reach adolescence.2,3 IMPACT was the first randomized, placebo-controlled trial to test pnOIT in children aged 1 to 3 years, showing greater desensitization and remission rates than typically reported in older cohorts.¹ IMPACT-PLuS was designed specifically to answer whether these early gains persist, following participants 8 to 11 years after their original enrollment.
"OIT is not the best treatment choice for everyone," said Jennifer A. Dantzer, MD, MHS, assistant professor of pediatrics, Johns Hopkins University School of Medicine, "but it's something a family with a food allergy could discuss with their allergist, weighing the risks and benefits to see if it makes sense for their family."
IMPACT enrolled 146 children aged 12 to 47 months at 5 US sites, randomizing them 2:1 to pnOIT (2000 mg peanut protein daily) or placebo for 134 weeks, then 26 weeks of avoidance.¹ At the end of the trial, 71% of pnOIT-treated participants met desensitization criteria on an oral food challenge, compared with 2% of the placebo group.¹ Separately, 21% achieved remission after passing a 5000 mg peanut challenge following 26 weeks off therapy.¹
IMPACT-PLuS re-enrolled 78 of the original 146 participants (53%) between April 2023 and February 2024, then aged 9 to 14 years, a median of 9 years after their original enrollment.1 The primary analysis centered on group A, the 40 pnOIT-treated participants who pursued no additional peanut-directed intervention after IMPACT ended. In this group, 80% were still eating peanut at follow-up, and 35% were consuming ≥ 1000 mg of peanut protein in a single serving.1
Across the full pnOIT follow-up cohort of 58 participants, including those who pursued additional therapy after IMPACT, 83% remained peanut tolerant.1 This continuation rate exceeds the roughly 50% long-term rate reported in earlier OIT cohorts.1
All 15 participants from IMPACT's original remission group, those who passed a 5000 mg peanut challenge after 26 weeks of avoidance, were still eating peanut at follow-up, and none had reverted to full avoidance.1 In total, 60% were consuming ≥ 1000 mg of peanut protein per serving.1 Reactions were less frequent in this group than in participants who were desensitized without achieving remission or who were never desensitized, occurring in 14% versus 50% of those other subgroups (P =.12).1
Overall, 35% of group A reported an allergic reaction to peanuts since IMPACT ended, involving oral pruritus, hives, or wheezing.1 Eleven participants used medication to treat a reaction, and 5 received epinephrine.1 Eight participants (20%) had returned to peanut avoidance by follow-up, citing reactions, taste aversion, or difficulty maintaining the regimen.
"There's no test to say a patient would be fine spacing doses to an exact interval," Dantzer said. "I'd caution against spacing intervals without an allergist's guidance, since doing so could raise the risk of reactions for some patients."
Dantzer has no reported disclosures.
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