Peanut OIT Shows Sustained Tolerance in Toddlers; Low-Dose OIT Safe for Preschoolers

Swedish trial data showed slow up-dosing peanut oral immunotherapy achieved sustained tolerance in most toddlers with peanut allergy after 3 years of treatment. In a separate study from the Netherlands, low-dose oral immunotherapy was found to be safe and generally well tolerated in preschoolers with single or multiple food allergies.

The randomized SMACHO trial, published in The Lancet Regional Health – Europe, evaluated 75 children aged 1 to 3 years with confirmed peanut allergy, randomly assigning 50 children to oral immunotherapy (OIT) and 25 to peanut avoidance. After 3 years of treatment followed by a 4- to 6-week peanut-free period, 82% of children in the OIT group tolerated at least 750 mg of peanut protein—equivalent to approximately 3.5 peanuts—without an allergic reaction, compared with 12% in the avoidance group. Among children completing the protocol, 98% achieved sustained unresponsiveness to at least 750 mg peanut protein after the treatment-free period, and 83% tolerated the maximum challenge dose of 5000 mg peanut protein, roughly equivalent to 25 peanuts.

Treatment began with a very small peanut dose administered in the hospital before transitioning to daily home dosing. Every 4 to 6 weeks, children returned for dose escalation until reaching a maintenance dose equivalent to approximately 1.5 peanuts daily. Investigators used commercially available peanut puffs for doses above 24 mg peanut protein. Across more than 43,000 administered peanut doses, adverse events occurred after 0.7% of doses and were primarily mild, including oral itching, lip symptoms, urticaria, and eczema. Six children experienced 8 severe dose-related reactions during treatment, most occurring during dose escalation. Epinephrine administration at home was reported 3 times in 2 children, all during the up-dosing phase. Severe reactions during final food challenges occurred in 2.4% of treated children compared with 25% of children in the avoidance group.

"This is the first randomised study of oral immunotherapy in toddlers involving a slow up-dosing and a low maintenance dose," said Caroline Nilsson, associate professor at the Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and senior consultant at Sachs' Children and Youth Hospital. "The peanut puffs were easily ingested, which made the treatment simple for families to follow, and we were surprised by how positive the results were."

Researchers emphasized that close medical supervision remains essential during treatment. "The cautious treatment approach appears to play an important role in safety, but this is not something that parents should attempt at home, as serious reactions can still occur," said Anna Asarnoj, associate professor at the Department of Women's and Children's Health, Karolinska Institutet, and senior consultant at Astrid Lindgren Children's Hospital, Karolinska University Hospital.

In the Dutch study, published in Frontiers in Allergy, researchers assessed 124 children (median age at inclusion, 17 months; 68.5% boys), of whom 80 received single OIT and 44 received multifood OIT. Peanut was the most frequently treated allergen (n = 52), followed by cashew nut (n = 46) and hen's egg (n = 38). Overall, 71.8% of children experienced allergic reactions within 2 hours of taking OIT, and 25.8% experienced nonallergic reactions. Ten severe reactions (Sampson grade 3-4) were reported, with only one requiring epinephrine administration. Temporary therapy adjustments, including dose reductions, therapy interruptions, and pretreatment with antihistamines, were required in 37.4% of children. Overall, 9.7% of children discontinued OIT, with 7.26% stopping because of therapy-related adverse events.

"If ongoing and future studies confirm the efficacy of preschool OIT, it could significantly change the standard of care for food allergy. OIT may be a rescue for many preschool-aged children in whom food allergy has already reached clinical disease expression," the authors of the study wrote.

A separate survey study examined the role of allergists in managing caregiver anxiety related to children's food allergies. The survey, published in the Annals of Allergy, Asthma & Immunology, included 419 caregivers of children with at least one immunoglobulin E-mediated food allergy. Only 16% of survey-takers reported their child's allergist had offered strategies to decrease either their own anxiety or that of their child. This subgroup was twice as likely to report a decrease in food allergy-related anxiety and worry compared with those who did not receive such guidance (odds ratio, 2.13; 95% CI, 1.26-3.62). Additionally, 32% of caregivers reported the allergist helped their child feel more comfortable about managing their food allergies, and these families were four times more likely to report a decrease in food allergy-related anxiety and worry (OR, 4.01; 95% CI, 2.59-6.22).