Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy

J Allergy Clin Immunol. 2016 Apr;137(4):1117-1127.e10. doi: 10.1016/j.jaci.2015.12.1316. Epub 2016 Mar 9.


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.

Trial registration: ClinicalTrials.gov NCT00461097.

Keywords: Egg allergy; IgE; desensitization; follow-up; food allergy; immune tolerance; oral immunotherapy; sustained unresponsiveness.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Desensitization, Immunologic / methods*
  • Double-Blind Method
  • Egg Hypersensitivity / immunology
  • Egg Hypersensitivity / therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00461097