The University of Southampton
University of Southampton Institutional Repository
Warning ePrints Soton is experiencing an issue with some file downloads not being available. We are working hard to fix this. Please bear with us.

Randomized trial of peanut consumption in infants at risk for peanut allergy

Randomized trial of peanut consumption in infants at risk for peanut allergy
Randomized trial of peanut consumption in infants at risk for peanut allergy
BACKGROUND: The prevalence of peanut allergy among children in Western countries has doubled in the past 10 years, and peanut allergy is becoming apparent in Africa and Asia. We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy.

METHODS: We randomly assigned 640 infants with severe eczema, egg allergy, or both to consume or avoid peanuts until 60 months of age. Participants, who were at least 4 months but younger than 11 months of age at randomization, were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract, which was determined with the use of a skin-prick test--one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter. The primary outcome, which was assessed independently in each cohort, was the proportion of participants with peanut allergy at 60 months of age.

RESULTS: Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test, the prevalence of peanut allergy at 60 months of age was 13.7% in the avoidance group and 1.9% in the consumption group (P<0.001). Among the 98 participants in the intention-to-treat population who initially had positive test results, the prevalence of peanut allergy was 35.3% in the avoidance group and 10.6% in the consumption group (P=0.004). There was no significant between-group difference in the incidence of serious adverse events. Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody. A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4:IgE were associated with peanut allergy.

CONCLUSIONS: The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00329784.).
803-813
Du Toit, George
7930b820-e6f7-4c4c-866c-4334017d1106
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Sayre, Peter H.
d9839665-ad89-43ff-b4fd-1f048446a182
Bahnson, Henry T.
2ecc6945-97fd-46bc-8d46-42606d4ccfe0
Radulovic, Suzana
8e9bce98-67a2-4999-9898-ccae71e55aa3
Santos, Alexandra F.
f5b69586-7f5c-4972-88dd-c463990bda94
Brough, Helen A.
ad550b22-eed8-4a61-9703-bd16aea45873
Phippard, Deborah
641cee80-36a2-4c93-8710-83fb509bb98f
Basting, Monica
0b4bc8e4-88a3-46d5-80ee-40228ad58c17
Feeney, Mary
29a6a117-af58-431f-90ad-d29495c665c8
Turcanu, Victor
8cfa4bfb-3ef3-484d-8211-3572a1754185
Sever, Michelle L.
77ce753e-b94e-4304-8e98-01719887348e
Gomez Lorenzo, Margarita
4319b080-6f7c-4cd0-a69e-15a930b8a6ac
Plaut, Marshall
d6491653-2a2f-4a73-bbfa-cb9b541fac46
Lack, Gideon
cac030a2-c358-4880-a91d-d67d06e8e321
Du Toit, George
7930b820-e6f7-4c4c-866c-4334017d1106
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Sayre, Peter H.
d9839665-ad89-43ff-b4fd-1f048446a182
Bahnson, Henry T.
2ecc6945-97fd-46bc-8d46-42606d4ccfe0
Radulovic, Suzana
8e9bce98-67a2-4999-9898-ccae71e55aa3
Santos, Alexandra F.
f5b69586-7f5c-4972-88dd-c463990bda94
Brough, Helen A.
ad550b22-eed8-4a61-9703-bd16aea45873
Phippard, Deborah
641cee80-36a2-4c93-8710-83fb509bb98f
Basting, Monica
0b4bc8e4-88a3-46d5-80ee-40228ad58c17
Feeney, Mary
29a6a117-af58-431f-90ad-d29495c665c8
Turcanu, Victor
8cfa4bfb-3ef3-484d-8211-3572a1754185
Sever, Michelle L.
77ce753e-b94e-4304-8e98-01719887348e
Gomez Lorenzo, Margarita
4319b080-6f7c-4cd0-a69e-15a930b8a6ac
Plaut, Marshall
d6491653-2a2f-4a73-bbfa-cb9b541fac46
Lack, Gideon
cac030a2-c358-4880-a91d-d67d06e8e321

Du Toit, George, Roberts, Graham, Sayre, Peter H., Bahnson, Henry T., Radulovic, Suzana, Santos, Alexandra F., Brough, Helen A., Phippard, Deborah, Basting, Monica, Feeney, Mary, Turcanu, Victor, Sever, Michelle L., Gomez Lorenzo, Margarita, Plaut, Marshall and Lack, Gideon (2015) Randomized trial of peanut consumption in infants at risk for peanut allergy. New England Journal of Medicine, 372 (9), 803-813. (doi:10.1056/NEJMoa1414850). (PMID:25705822)

Record type: Article

Abstract

BACKGROUND: The prevalence of peanut allergy among children in Western countries has doubled in the past 10 years, and peanut allergy is becoming apparent in Africa and Asia. We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy.

METHODS: We randomly assigned 640 infants with severe eczema, egg allergy, or both to consume or avoid peanuts until 60 months of age. Participants, who were at least 4 months but younger than 11 months of age at randomization, were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract, which was determined with the use of a skin-prick test--one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter. The primary outcome, which was assessed independently in each cohort, was the proportion of participants with peanut allergy at 60 months of age.

RESULTS: Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test, the prevalence of peanut allergy at 60 months of age was 13.7% in the avoidance group and 1.9% in the consumption group (P<0.001). Among the 98 participants in the intention-to-treat population who initially had positive test results, the prevalence of peanut allergy was 35.3% in the avoidance group and 10.6% in the consumption group (P=0.004). There was no significant between-group difference in the incidence of serious adverse events. Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody. A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4:IgE were associated with peanut allergy.

CONCLUSIONS: The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00329784.).

Text
DU TOIT LEAP NEJM 2015.pdf - Accepted Manuscript
Restricted to Repository staff only
Request a copy

More information

Published date: 26 February 2015
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 388684
URI: http://eprints.soton.ac.uk/id/eprint/388684
PURE UUID: 4be1d7e3-9967-4cd3-a2ad-fb8a5ad6deb0
ORCID for Graham Roberts: ORCID iD orcid.org/0000-0003-2252-1248

Catalogue record

Date deposited: 02 Mar 2016 09:25
Last modified: 13 Nov 2021 02:43

Export record

Altmetrics

Contributors

Author: George Du Toit
Author: Graham Roberts ORCID iD
Author: Peter H. Sayre
Author: Henry T. Bahnson
Author: Suzana Radulovic
Author: Alexandra F. Santos
Author: Helen A. Brough
Author: Deborah Phippard
Author: Monica Basting
Author: Mary Feeney
Author: Victor Turcanu
Author: Michelle L. Sever
Author: Margarita Gomez Lorenzo
Author: Marshall Plaut
Author: Gideon Lack

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×