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Peanut patch trial produces mixed results
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Young children with peanut allergy who received 12 months of treatment with a peanut patch had a significant difference in treatment response rate vs. those who received placebo, according to findings published in JAMA. However, the trial did not meet a prespecified criterion for a positive trial result.
“Several approaches to treating peanut allergy have been evaluated, including oral, sublingual, and epicutaneous immunotherapies,” David M. Fleischer, MD, of Children’s Hospital in Colorado and colleagues, wrote.
“While both oral and sublingual immunotherapies are well described, less is known about epicutaneous immunotherapy. Epicutaneous immunotherapy uses substantially lower dosing (micrograms vs. milligrams), avoids oral allergen ingestion, and may have a more advantageous adverse event profile and better adherence than other therapies,” they added.
Fleischer and colleagues conducted a phase 3 double-blind trial with 356 children aged between 4 and 11 years without severe anaphylactic reaction history. These children (mean age, 7 years) were randomly assigned to receive an eliciting dose of either 300 mg or less of peanut protein or a placebo.
The primary outcome was the percentage difference in responders between these two groups predicated on eliciting dose as ascertained by food challenges at baseline and the 12th month. A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was specified before the trial to ascertain a positive trial result, according to researchers.
Fleischer and colleagues found that the responder rate was 35.3% in those who received peanut-patch treatment compared with 13.6% in those who received placebo (difference, 21.7%; 95% CI,12.4-29.8). However, the prespecified lower bound of the CI threshold was not met.
“The clinical relevance of not meeting this lower bound of the confidence interval with respect to the treatment of peanut allergic children with epicutaneous immunotherapy remains to be determined,” researchers wrote.
In addition, and regardless of treatment received, pruritus, erythema and site swelling were the most common treatment-emergent adverse events. These reactions occurred in 95.4% of those who received the peanut patch and 89% of those who received placebo. The rate of study discontinuation, across all causes, was 10.5% in the peanut-patch group compared to 9.3% in the placebo group, according to researchers. – by Janel Miller
Disclosures: Please see the study for the authors’ relevant financial disclosures.