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

Publication date: Available online 10 November 2018

Source: The Journal of Allergy and Clinical Immunology: In Practice

Author(s): Katharina Blumchen, Valerie Trendelenburg, Frank Ahrens, Armin Gruebl, Eckard Hamelmann, Gesine Hansen, Andrea Heinzmann, Katja Nemat, Thomas Holzhauser, Martin Roeder, Leonard Rosenfeld, Oliver Hartmann, Bodo Niggemann, Kirsten Beyer

Abstract

Background

Only two, small placebo-controlled trials on peanut- oral immunotherapy (OIT) have been published.

Objective

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.

Methods

62 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.

Results

23/31 (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 group (p<.001). 13/31 (41.9%) children of the active versus 1/31 (3.2%) of the placebo group tolerated the highest dose of 4.5 g peanut protein at final OFC (p<.001). There was no significant difference between the groups in the occurrence of AE-related drop-outs or in the number, severity and treatment of objective AEs. In the peanut-OIT group, we noted a significant reduction in peanut specific IL-4, IL-5, IL10 and IL-2 production by PBMCs compared to the placebo group, as well as a significant increase in peanut specific-IgG4 levels and a significant improvement of QoL. 86% of children evaluated the BoT positively.

Discussion

Low-dose OIT is a promising, effective and safe treatment option for peanut allergic children, leading to improvement of QoL, a low BoT and immunological changes showing tolerance development.

from #Head and Neck by Sfakianakis via simeraentaxei on Inoreader https://ift.tt/2z5l3tp