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Ensayo controlado aleatorizado2012

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 · 523 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento
Consumo medido con
No se indica

Quién lo pagó

Financiación
Financiación independiente
Gobierno
National Institute of Allergy and Infectious Diseases
Gobierno
National Institute of Diabetes and Digestive and Kidney Diseases
Gobierno
National Center for Research Resources
Gobierno
NCRR NIH HHS
Gobierno
NIAID NIH HHS
Gobierno
NIDDK NIH HHS
Subvenciones
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)

Según 6 financiadores declarados.

Publicación

Publicado
2012-07-19 · N Engl J Med · vol. 367 · número 3 · págs. 233–243
Editorial
Massachusetts Medical Society
Citado
706 citas · más que el 100% de estudios similares · 33.3× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
40 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Food Allergy and Anaphylaxis Research · Pediatric health and respiratory diseases · Allergic Rhinitis and Sensitization
Palabras clave
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 autores

  • A. Wesley Burks🇺🇸Duke University; Duke Medical Center
  • Stacie M. Jones🇺🇸Arkansas Children's Hospital; University of Arkansas for Medical Sciences
  • Robert A. Wood🇺🇸Johns Hopkins University; University Medical Center
  • David Mark Fleischer🇺🇸National Jewish Health; University of Colorado Denver
  • Scott Howard Sicherer🇺🇸Icahn School of Medicine at Mount Sinai
  • Robert Lindblad🇺🇸Emmes (United States)
  • Donald M. Stablein🇺🇸Emmes (United States)
  • Alice K. Henning🇺🇸Emmes (United States)
  • Brian P. Vickery🇺🇸Duke Medical Center
  • Andrew H. Liu🇺🇸National Jewish Health; University of Colorado Denver
  • Amy M. Scurlock🇺🇸Arkansas Children's Hospital; University of Arkansas for Medical Sciences
  • Wayne G. Shreffler🇺🇸Harvard University; Massachusetts General Hospital
  • Marshall Plaut🇺🇸National Institutes of Health
  • Hugh A. Sampson🇺🇸Icahn School of Medicine at Mount Sinai

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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