Early Intervention with Oral Immunotherapy is a Promising Strategy for the Treatment of Peanut Allergy

Abstract

RationalePeanut oral immunotherapy (OIT) causes desensitization, but long-term tolerance induction has not been shown and safety and adherence remain important concerns. We designed a clinical trial to test the hypothesis that early intervention (EI) improves the efficacy of peanut OIT without adversely affecting safety or adherence.MethodsForty peanut-sensitized children aged 9-36 months were enrolled within six months of their initial reaction, or if the peanut-specific IgE (psIgE) exceeded 5 kUA/L in the absence of exposure. All subjects underwent baseline oral peanut challenge and were randomized to receive low- or high-dose OIT. Peanut-specific immune responses were serially analyzed. We utilized our research database to compare demographic, safety, adherence, and immunologic data between the EI cohort and an ongoing, previously reported trial of OIT in older children (PMIT).ResultsCompared to the PMIT group, at enrollment subjects receiving EI had lower median age (30 mo vs. 58 mo) and psIgE levels (15 kUA/L vs. 87 kUA/L) [both p<0.0001]. EI subjects were approximately half as likely as PMIT subjects to have an allergic side effect (ASE) deemed “likely” or “possibly” related to OIT [RR 0.56 (95%CI 0.50-0.62), p<0.0001]. Study termination due to ASE occurred in 3/26 (11.5%) PMIT compared to 1/40 (2.5%) EI [p=0.29]. After one year, peanut skin test size decreased similarly in both groups, and psIgE levels remained stable.ConclusionsEarly intervention with OIT may enhance safety and targets young peanut-allergic children for treatment while their psIgE levels are low. This may lead to improved long term outcomes. RationalePeanut oral immunotherapy (OIT) causes desensitization, but long-term tolerance induction has not been shown and safety and adherence remain important concerns. We designed a clinical trial to test the hypothesis that early intervention (EI) improves the efficacy of peanut OIT without adversely affecting safety or adherence. Peanut oral immunotherapy (OIT) causes desensitization, but long-term tolerance induction has not been shown and safety and adherence remain important concerns. We designed a clinical trial to test the hypothesis that early intervention (EI) improves the efficacy of peanut OIT without adversely affecting safety or adherence. MethodsForty peanut-sensitized children aged 9-36 months were enrolled within six months of their initial reaction, or if the peanut-specific IgE (psIgE) exceeded 5 kUA/L in the absence of exposure. All subjects underwent baseline oral peanut challenge and were randomized to receive low- or high-dose OIT. Peanut-specific immune responses were serially analyzed. We utilized our research database to compare demographic, safety, adherence, and immunologic data between the EI cohort and an ongoing, previously reported trial of OIT in older children (PMIT). Forty peanut-sensitized children aged 9-36 months were enrolled within six months of their initial reaction, or if the peanut-specific IgE (psIgE) exceeded 5 kUA/L in the absence of exposure. All subjects underwent baseline oral peanut challenge and were randomized to receive low- or high-dose OIT. Peanut-specific immune responses were serially analyzed. We utilized our research database to compare demographic, safety, adherence, and immunologic data between the EI cohort and an ongoing, previously reported trial of OIT in older children (PMIT). ResultsCompared to the PMIT group, at enrollment subjects receiving EI had lower median age (30 mo vs. 58 mo) and psIgE levels (15 kUA/L vs. 87 kUA/L) [both p<0.0001]. EI subjects were approximately half as likely as PMIT subjects to have an allergic side effect (ASE) deemed “likely” or “possibly” related to OIT [RR 0.56 (95%CI 0.50-0.62), p<0.0001]. Study termination due to ASE occurred in 3/26 (11.5%) PMIT compared to 1/40 (2.5%) EI [p=0.29]. After one year, peanut skin test size decreased similarly in both groups, and psIgE levels remained stable. Compared to the PMIT group, at enrollment subjects receiving EI had lower median age (30 mo vs. 58 mo) and psIgE levels (15 kUA/L vs. 87 kUA/L) [both p<0.0001]. EI subjects were approximately half as likely as PMIT subjects to have an allergic side effect (ASE) deemed “likely” or “possibly” related to OIT [RR 0.56 (95%CI 0.50-0.62), p<0.0001]. Study termination due to ASE occurred in 3/26 (11.5%) PMIT compared to 1/40 (2.5%) EI [p=0.29]. After one year, peanut skin test size decreased similarly in both groups, and psIgE levels remained stable. ConclusionsEarly intervention with OIT may enhance safety and targets young peanut-allergic children for treatment while their psIgE levels are low. This may lead to improved long term outcomes. Early intervention with OIT may enhance safety and targets young peanut-allergic children for treatment while their psIgE levels are low. This may lead to improved long term outcomes.