Randomized controlled trial2012

Oral immunotherapy for treatment of egg allergy in children

Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, Stablein D, Henning AK, Vickery BP, Liu AH, Scurlock AM, Shreffler WG, Plaut M, Sampson HA, Consortium of Food Allergy Research (CoFAR)

The New England journal of medicine · 521 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function
Intake measured by
Not stated

Who paid for it

Funding
Independent funding
Government
National Institute of Allergy and Infectious Diseases
Government
National Institute of Diabetes and Digestive and Kidney Diseases
Government
National Center for Research Resources
Government
NCRR NIH HHS
Government
NIAID NIH HHS
Government
NIDDK NIH HHS
Grants
National Institute of Diabetes and Digestive and Kidney Diseases (P30 DK 040561); National Center for Research Resources (RR-025780); National Institute of Allergy and Infectious Diseases (U01 AI066560); National Center for Research Resources (UL 1 RR024128); National Center for Research Resources (UL1 RR029884); National Center for Research Resources (RR-024128); National Center for Research Resources (RR025005); National Center for Research Resources (UL1-RR‐029887); National Center for Research Resources (#UL1 RR025780); National Center for Research Resources (RR029887); National Center for Research Resources (UL1 RR025005.); National Center for Research Resources (RR029884); National Institute of Allergy and Infectious Diseases (U19 AI 066738)

Based on 6 listed funder(s).

Publication

Published
2012-07-19 · N Engl J Med · vol. 367 · issue 3 · pp. 233–243
Publisher
Massachusetts Medical Society
Cited
706 citations · more than 100% of similar papers · 33.3× the field average
Impact
Top 10% most cited in its field
References
40 works
Access
Free to read
Research areas
Food Allergy and Anaphylaxis Research · Pediatric health and respiratory diseases · Allergic Rhinitis and Sensitization
Keywords
Oral immunotherapy, Egg allergy, Immunotherapy, Allergy, Medicine, Immunology, Dermatology, Food allergy, Immune system
MeSH
humans, egg hypersensitivity, immunoglobulin e, immunoglobulin g, desensitization, immunologic, administration, oral, double-blind method, age of onset, eggs, child, child, preschool, female, male

14 authors

From US

  • A. Wesley BurksDuke University; Duke Medical Center
  • Stacie M. JonesArkansas Children's Hospital; University of Arkansas for Medical Sciences
  • Robert A. WoodJohns Hopkins University; University Medical Center
  • David Mark FleischerNational Jewish Health; University of Colorado Denver
  • Scott Howard SichererIcahn School of Medicine at Mount Sinai
  • Robert LindbladEmmes (United States)

Abstract

Background

For egg allergy, dietary avoidance is the only currently approved treatment. We evaluated oral immunotherapy using egg-white powder for the treatment of children with egg allergy.

Methods

In this double-blind, randomized, placebo-controlled study, 55 children, 5 to 11 years of age, with egg allergy received oral immunotherapy (40 children) or placebo (15). Initial dose-escalation, build-up, and maintenance phases were followed by an oral food challenge with egg-white powder at 10 months and at 22 months. Children who successfully passed the challenge at 22 months discontinued oral immunotherapy and avoided all egg consumption for 4 to 6 weeks. At 24 months, these children underwent an oral food challenge with egg-white powder and a cooked egg to test for sustained unresponsiveness. Children who passed this challenge at 24 months were placed on a diet with ad libitum egg consumption and were evaluated for continuation of sustained unresponsiveness at 30 months and 36 months.

Results

After 10 months of therapy, none of the children who received placebo and 55% of those who received oral immunotherapy passed the oral food challenge and were considered to be desensitized; after 22 months, 75% of children in the oral-immunotherapy group were desensitized. In the oral-immunotherapy group, 28% (11 of 40 children) passed the oral food challenge at 24 months and were considered to have sustained unresponsiveness. At 30 months and 36 months, all children who had passed the oral food challenge at 24 months were consuming egg. Of the immune markers measured, small wheal diameters on skin-prick testing and increases in egg-specific IgG4 antibody levels were associated with passing the oral food challenge at 24 months.

Conclusions

These results show that oral immunotherapy can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness in a clinically significant subset. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00461097.).

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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