Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy
- 1 September 2020
- journal article
- research article
- Published by S. Karger AG in International Archives of Allergy and Immunology
- Vol. 181 (9), 699-705
- https://doi.org/10.1159/000508627
Abstract
Introduction:Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required.Objectives:We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy.Methods:Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL;n= 19) or high (100 mL;n= 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated.Results:The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose,p= 0.000; high-dose,p= 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p= 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events;p= 0.018).Conclusions:An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.This publication has 9 references indexed in Scilit:
- Epidemiology of Cow’s Milk AllergyNutrients, 2019
- High‐ and low‐dose oral immunotherapy similarly suppress pro‐allergic cytokines and basophil activation in young childrenClinical & Experimental Allergy, 2018
- Diets Supplemented with 1% Egg White Induce Oral Desensitization and Immune Tolerance in an Egg White-Specific Allergic Mouse ModelInternational Archives of Allergy and Immunology, 2018
- Allergen immunotherapy for IgE-mediated food allergy: a systematic review and meta-analysisAllergy, 2017
- Erratum to: Two-weeks-sustained unresponsiveness by oral immunotherapy using microwave heated cow’s milk for children with cow’s milk allergyAllergy, Asthma & Clinical Immunology, 2016
- A Single-Center, Case-Control Study of Low-Dose-Induction Oral Immunotherapy with Cow's MilkInternational Archives of Allergy and Immunology, 2015
- Japanese Guideline for Food Allergy 2014Allergology International, 2014
- Evaluation of a portable manual for parents of children with food allergies that assesses the severity of allergic symptomsNihon Shoni Arerugi Gakkaishi. The Japanese Journal of Pediatric Allergy and Clinical Immunology, 2014
- Rush oral immunotherapy in children with persistent cow's milk allergyJournal of Allergy and Clinical Immunology, 2008