COMPARING SYMPTOM SEVERITY BETWEEN BASELINE AND 1-YEAR ORAL FOOD CHALLENGES IN PEANUT ORAL IMMUNOTHERAPY

Abstract

Introduction Peanut oral immunotherapy (POIT) trials have examined the adverse effects of double blind placebo-controlled food challenges (DBPCFC) with a cumulative top dose of 5000mg of peanut protein following maintenance dosing. Comparison of the severity of adverse reactions during DBPCFC beyond 5000mg of peanut protein between baseline and 1 year have not yet been evaluated. Methods In a single center phase 1 clinical trial of POIT, patients underwent a baseline DBPCFC, subsequent build-up daily dosing to 3900mg of peanut protein over 1-year, followed by a second DBPCFC to a cumulative dose of 26,225mg. Total symptom score (TSS) was determined by the sum of the individual system symptom severity scores during the challenge reaction (1=mild, 2=moderate, 3=severe). Challenge TSS and system scores were compared at baseline and after 1 year of treatment by the Kruskal-Wallis test. Results In 12 POIT subjects, DBPCFC symptoms decreased in 83% of patients after 1 year of therapy when compared to baseline. Mean TSS was 8.6 (4-16) at baseline and 4.5 (0-10) at 1 year (p Conclusions Overall, in this POIT trial with 3900mg maintenance dosing, symptoms during a DBPCFC beyond 5000mg significantly improved from baseline to 1 year. Specifically, respiratory and gastrointestinal symptom severity decreased. After high-dose POIT, most patients experience reduced severity of allergic reactions to peanut.