Efficacy, safety, and quality of life in a multi-center, randomized, placebo-controlled trial of low-dose peanut oral immunotherapy in peanut allergic children

We examined the efficacy, safety, immunological parameters, quality of life (QoL) and burden of treatment (BoT) of low-dose peanut- OIT in a multicenter, double-blind, randomized placebo-controlled trial.Methods62 children aged 3-17 years with IgE-mediated, challenge-proven peanut allergy were randomized (1:1) to receive peanut-OIT with a maintenance dose of 125-250 mg peanut protein or placebo. The primary outcome was the proportion of children tolerating ≥300 mg peanut protein at oral food challenge (OFC) after 16 months of OIT. We measured occurrence of adverse events (AEs), immunological changes, QoL prior and post OIT and BoT during OIT.Results23/31 (74.2%) children of the active group tolerated at least 300 mg peanut protein at final OFC compared to 5 /31 (16.1%) in the placebo gro...

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