Early sustained unresponsiveness after short-course egg oral immunotherapy: a randomized controlled study in egg-allergic children

Clin Exp Allergy. 2015 Dec;45(12):1833-43. doi: 10.1111/cea.12604.

Abstract

Background: No studies have evaluated the potential of egg oral immunotherapy (egg-OIT) to induce sustained unresponsiveness after discontinuing therapy following short-term treatments.

Objective: We assessed the efficacy of short-course egg-OIT to induce sustained unresponsiveness.

Methods: Sixty-one egg-allergic children, 5 to 17 years old, with positive double-blind placebo-controlled food challenge (DBPCFC) to dehydrated egg white (EW) were randomized to receive egg-OIT (OITG) for 3 months (maintenance dose one undercooked egg every 48 hours) or to continue egg avoidance diet (control group, CG) for 4 months. Children who completed egg-OIT avoided egg for 1 month. At 4 months, both groups underwent a DBPCFC. OITG participants who passed this challenge were instructed to add egg to their diet ad libitum. Immune markers were studied at different time points.

Results: Ninety-three percent (28/30) of OITG children were desensitized in a median of 32.5 days (IQR, 14 days). At 4 months, 1/31 (3%) in CG passed DBPCFC and 11/30 (37%) of OITG (95% CI, 14 to 51%; P = 0.003), all of them were consuming egg at 36 months. A decrease in EW, OVA and OVM skin test results and OVA-specific IgE (sIgE) levels was observed on OITG at 4 months (P = 0.001). EW-, OVA- and OVM-sIgE levels prior to the start of egg avoidance diet were lower in OITG children who passed DBPCFC at 4 months than in those who did not pass it. EW- and OVM-sIgE showed the best diagnostic performance in predicting DBPCFC result at 4 months. Levels above optimal EW-sIgE cut-off of 7.1 kU/L indicated 90% probability of failing DBPCFC.

Conclusion: This is the first demonstration of sustained unresponsiveness with a three-month egg-OIT protocol. Almost all treated subjects were desensitized and 37% achieved sustained unresponsiveness. EW-sIgE levels at the end of treatment predicted sustained unresponsiveness. This protocol shows a new approach to OIT for egg-allergic children.

Keywords: clinical tolerance; desensitization; egg allergy; food allergy; oral immunotherapy; sustained unresponsiveness.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Allergens / administration & dosage
  • Allergens / immunology*
  • Biomarkers
  • Child
  • Child, Preschool
  • Desensitization, Immunologic* / adverse effects
  • Desensitization, Immunologic* / methods
  • Egg Hypersensitivity / diagnosis
  • Egg Hypersensitivity / immunology*
  • Egg Hypersensitivity / therapy*
  • Egg White / adverse effects
  • Eggs / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Immunoglobulin E / blood
  • Immunoglobulin E / immunology
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology
  • Male
  • Risk Factors
  • Skin Tests
  • Time Factors
  • Treatment Outcome

Substances

  • Allergens
  • Biomarkers
  • Immunoglobulin G
  • Immunoglobulin E