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J Allergy Clin Immunol Pract. 2019 Feb;7(2):479-491.e10. doi: 10.1016/j.jaip.2018.10.048. Epub 2018 Nov 10.

Efficacy, Safety, and Quality of Life in a Multicenter, Randomized, Placebo-Controlled Trial of Low-Dose Peanut Oral Immunotherapy in Children with Peanut Allergy.

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Department of Children and Adolescent Medicine, Division of Pneumology, Allergology and Cystic fibrosis, University Hospital Frankfurt, Frankfurt am Main, Germany; Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address:
Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
Children's Hospital "Altona", Hamburg, Germany.
Department of Pediatrics, Technical University Munich, Munich, Germany.
Department of Pediatrics, Allergy Center, Ruhr-University Bochum, Bochum, Germany; Children's Center Bethel, EvKB, Bielefeld, Germany.
Department of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.
Department of Pediatrics and Adolescent Medicine, University Medical Center, Medical Faculty, University of Freiburg, Freiburg, Germany.
Department of Pediatrics, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.
Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany.
Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany; Institute for Product Quality (IFP), Berlin, Germany.
Sphingotec, Hennigsdorf, Germany.



Only 2 small placebo-controlled trials on peanut oral immunotherapy (OIT) have been published.


We examined the efficacy, safety, immunologic parameters, quality of life (QOL), and burden of treatment (BOT) of low-dose peanut OIT in a multicenter, double-blind, randomized placebo-controlled trial.


A total of 62 children aged 3 to 17 years with IgE-mediated, challenge-proven peanut allergy were randomized (1:1) to receive peanut OIT with a maintenance dose of 125 to 250 mg peanut protein or placebo. The primary outcome was the proportion of children tolerating 300 mg or more peanut protein at oral food challenge (OFC) after 16 months of OIT. We measured the occurrence of adverse events (AEs), immunologic changes, and QOL before and after OIT and BOT during OIT.


Twenty-three of 31 (74.2%) children of the active group tolerated at least 300 mg peanut protein at final OFC compared with 5 of 31 (16.1%) in the placebo group (P < .001). Thirteen of 31 (41.9%) children of the active versus 1 of 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 dropouts 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, IL-10, and IL-2 production by PBMCs compared with the placebo group, as well as a significant increase in peanut-specific IgG4 levels and a significant improvement in QOL; 86% of children evaluated the BOT positively.


Low-dose OIT is a promising, effective, and safe treatment option for peanut-allergic children, leading to improvement in QOL, a low BOT, and immunologic changes showing tolerance development.


Children; Desensitization; Induction; Oral immunotherapy; Peanut allergy; Tolerance


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