title: Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy.
abstract: BACKGROUND
  We previously reported the results of a randomized placebo-controlled study of egg oral immunotherapy (eOIT) in which 27.5% of subjects achieved sustained unresponsiveness (SU) after 2 years. Here we report the results of treatment through 4 years and long-term follow-up.
  
  
  OBJECTIVE
  We sought to evaluate the efficacy and safety of eOIT in participants treated up to 4 years.
  
  
  METHODS
  Children with egg allergy (5-18 years old) received eOIT (n = 40) for up to 4 years or placebo (n = 15) for 1 year or less. The key outcome was the percentage of subjects achieving SU by year 4. Safety and immunologic assessments were performed, and long-term follow-up questionnaires (LFQs) were administered after study conclusion (LFQ-1) and 1 year later (LFQ-2).
  
  
  RESULTS
  Of 40 eOIT-treated subjects, 20 (50.0%) of 40 demonstrated SU by year 4. For those subjects still dosing during years 3 and 4, mild symptoms were present in 12 (54.5%) of 22 subjects. At the time of the LFQ, more subjects receiving eOIT (LFQ-1, 23/34 [68%]; LFQ-2, 21/33 [64%]) were consuming unbaked and baked egg versus placebo (LFQ-1, 2/11 [18%], P = .006; LFQ-2, 3/12 [25%], P = .04). Of subjects achieving SU, 18 (90%) of 20 completed the LFQ, with 18 (100%) of 18 reporting consumption of all forms of egg. When compared with subjects not achieving SU, subjects achieving SU had higher IgG4 values (P = .001) and lower egg skin prick test scores (P = .0002) over time and a lower median baseline ratio of egg-specific IgE to total IgE (1.1% vs 2.7%, P = .04).
  
  
  CONCLUSIONS
  SU after eOIT is enhanced with longer duration of therapy and increases the likelihood of tolerating unbaked egg in the diet.
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: JonesStacieM@uams.edu.
authors.forename: Stacie M
authors.initials: SM
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.affiliation: Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md.
authors.forename: Corinne
authors.initials: C
authors.lastname: Keet
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
authors.forename: Brian P
authors.initials: BP
authors.lastname: Vickery
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Scurlock
authors.affiliation: Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Md.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wood
authors.affiliation: Department of Pediatrics, National Jewish Health, Denver, Colo.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Liu
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Scott H
authors.initials: SH
authors.lastname: Sicherer
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Alice K
authors.initials: AK
authors.lastname: Henning
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Lindblad
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Peter
authors.initials: P
authors.lastname: Dawson
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Berin
authors.affiliation: Department of Pediatrics, National Jewish Health, Denver, Colo.
authors.forename: David M
authors.initials: DM
authors.lastname: Fleischer
authors.affiliation: Department of Pediatrics, National Jewish Health, Denver, Colo.
authors.forename: Donald Y M
authors.initials: DYM
authors.lastname: Leung
authors.affiliation: National Institutes of Health (National Institute of Allergy and Infectious Diseases), Bethesda, Md.
authors.forename: Marshall
authors.initials: M
authors.lastname: Plaut
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Sampson
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D021181:Egg Hypersensitivity / Q000276:immunology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Egg allergy; IgE; desensitization; follow-up; food allergy; immune tolerance; oral immunotherapy; sustained unresponsiveness