AGE-RELATED FINDINGS FROM THE PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION (PALISADE) STUDY

摘要

IntroductionOral immunotherapy (OIT) with AR101 is being developed for treatment of peanut allergy (PA). To better understand the promising phase 3 results, we sought to determine whether there were age-related treatment effects. MethodsThis randomized, double-blind, placebo-controlled study evaluated safety and efficacy of AR101, an investigational biologic OIT drug, in peanut-allergic subjects aged 4-55 years. ?The primary endpoint was the proportion of subjects aged 4-17 years tolerating a single-highest dose of ≥600mg of peanut protein at exit double-blind, placebo-controlled food challenge. ?This abstract presents age-specific (4-11, 12-17, 18-55 years) safety and efficacy analyses. ResultsThe proportions of subjects tolerating ≥600mg peanut protein (AR101 versus placebo) by age were: 4-11-year-olds: 70.6% versus 4.5% (Δ: 66.1% [95% CI: 53.9, 78.3; p<0.0001]); 12-17-year-olds: 61.2% versus 2.9% (Δ: 58.3% [95% CI: 39.7, 76.9; p<0.0001]); 18-55-year-olds: 41.5% versus 14.3% (Δ: 27.2% [95% CI -1.7, 56.0; p=0.07] (Table). Treatment-emergent allergic hypersensitivity adverse events were mostly mild-to-moderate in severity and affected 86.1% and 69.7% of active and placebo recipients aged 4-11 years, respectively; 89.6% and 68.6% of active and placebo recipients aged 12-17 years, respectively; and 87.8% and 78.6% of active and placebo recipients aged 18-55 years, respectively. One case of eosinophilic esophagitis was documented (4-11 years). ConclusionsAR101 treatment appeared to demonstrate clinical desensitization and an acceptable safety profile in children and adolescents with PA. Intent-to-treat results in adults were not statistically significant; however, among completers, the percentage of subjects tolerating ≥600mg peanut protein was consistent across all age groups.Table.Desensitization response rates for subjects aged 4–11, 12–17, and 18–55 years who tolerated at least 600 mg peanut protein with no symptoms or only mild allergy symptoms at the exit DBPCFC.