Low doses of peanut early in life may lead to long-term allergy control

(Press Release)

Houston, TX – An early-intervention oral immunotherapy (EI-OIT) trial for peanut allergy shows promising results and could represent a new, effective approach to food allergy management.

“Although the results from several OIT trials have been encouraging, there are still many ongoing concerns primarily related to safety and long-term effectiveness. In addition, there is very little understanding of which individuals should be selected for therapy and with what dose. Based on studies that showed how peanut allergy develops early in life, we developed the hypothesis that treating young children with OIT shortly after their diagnosis would more easily correct the immune response and lead to improved outcomes,” according to Brian P. Vickery, MD, FAAAAI, of UNC-Chapel Hill.

Results were made public at The American Academy of Allergy, Asthma & Immunology 2015 Annual Meeting, which demonstrated that early-intervention OIT was relatively safe and led to a high proportion of subjects achieving the primary outcome, sustained unresponsiveness (SU).

The researchers enrolled 40 children aged 9-36 months. Those who had previously had an allergic reaction to peanut were enrolled within six months of their first reaction. Others entered the study with positive peanut testing and no history of exposure. Qualifying subjects had an allergic reaction to peanut during an oral food challenge (OFC) performed at study entry who were then randomized to receive low- or high-dose OIT in a double-blind fashion. SU was assessed with an OFC performed four weeks after stopping OIT, when patients achieved predetermined goals, or completed three maintenance years.

“We observed an acceptable safety profile with EI-OIT, and the highest proportion of subjects reported to date that were able to achieve SU one month after stopping OIT,” Vickery said.

Of the 40 participants, three did not qualify, five withdrew for nonadherence or adverse events (including one child with eosinophilic esophagitis), and two are currently dosing. All 29 remaining 30 subjects who qualified for treatment and adhered to the dosing schedule successfully achieved SU.

While it is important to note that 80% experienced possibly-related adverse events during OIT, most were relatively mild. Peanut-specific IgE dramatically declined from the patients’ baseline numbers. The median concentration of allergic antibodies dropped from 13.6 kUa/L to only 1.8 kUa/L.

“Without a placebo group, we cannot say for sure that all of the favorable outcomes were caused by EI-OIT. However, the treatment was generally well-tolerated, and the success rate we observed with EI-OIT for peanut allergy was much higher than the 20% rate of spontaneous resolution reported in other studies,” Vickery said. “This is the first study to specifically target the preschool age group with peanut OIT and we are involved in an ongoing, multicenter, randomized, placebo-controlled trial to further test this idea.”

For more information on food allergies, oral immunotherapy, or the Annual Meeting, please visit the AAAAI website.