Reduction in Reaction Severity Following 12 Months of Epicutaneous Immunotherapy with Peanut Patch in Toddlers

Abstract

<h3>Introduction</h3> In a recent Phase 3 clinical trial (EPITOPE), treatment with a peanut patch containing 250 µg peanut protein for 12 months was statistically superior to placebo in desensitizing peanut-allergic children aged 1-3 years, with 67% vs 33.5% being treatment responders (difference: 33.4%; 95% CI: 22.4, 33.5 [p<0.001]). The ability of the peanut patch to reduce reaction severity, a major goal of allergen immunotherapy, was also characterized in a pre-specified analysis. <h3>Methods</h3> Double-blind, placebo-controlled food challenges (DBPCFC) were performed at baseline and Month 12 to determine eliciting dose (ED). Standardized DBPCFCs were stopped only after sufficient signs/symptoms, in accordance with PRACTALL guidelines. Symptoms in each body system were graded by prespecified criteria (scored 0-3). Maximum severity of symptoms at baseline and Month 12 between active and placebo groups was compared. <h3>Results</h3> At baseline, there was a similar proportion of mild/moderate/severe signs/symptoms between active and placebo (p=0.911). At baseline, an equal percentage of subjects in the active and placebo groups (24.6% in each group) had a maximum symptom severity score of 3 ("severe"). At Month 12, there was a significant difference between groups in maximum symptom severity (p<0.001), with 12.5% of active subjects having a symptom severity score of 3 ("severe") compared with 28.6% in placebo. At Month 12, 36.5% of active subjects had no or mild symptoms compared with 20.4% of placebo. <h3>Conclusion</h3> This analysis suggests that, in addition to achieving desensitization in 1-3-year-old peanut-allergic children, EPIT with a patch containing 250 µg peanut protein may also reduce the severity of allergic reactions.