title: Early sustained unresponsiveness after short-course egg oral immunotherapy: a randomized controlled study in egg-allergic children.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Allergy Department, Hospital InfantilUniversitario Niño Jesús, IIS-Princesa, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Escudero
authors.affiliation: Allergy Department, Hospital InfantilUniversitario Niño Jesús, IIS-Princesa, Madrid, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Rodríguez Del Río
authors.affiliation: Allergy Department, Hospital InfantilUniversitario Niño Jesús, IIS-Princesa, Madrid, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Sánchez-García
authors.affiliation: Allergy Department, Hospital InfantilUniversitario Niño Jesús, IIS-Princesa, Madrid, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Pérez-Rangel
authors.affiliation: Preventive Medicine Department, School of Medicine, Universidad Complutense, Madrid, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Pérez-Farinós
authors.affiliation: Preventive Medicine Department, Hospital Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: García-Fernández
authors.affiliation: Allergy Department, Hospital InfantilUniversitario Niño Jesús, IIS-Princesa, Madrid, Spain.
authors.forename: M D
authors.initials: MD
authors.lastname: Ibáñez
mesh_terms: D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D015415:Biomarkers; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods; D021181:Egg Hypersensitivity / Q000175:diagnosis / Q000276:immunology* / Q000628:therapy*; D004529:Egg White / Q000009:adverse effects; D004531:Eggs / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D008297:Male; D012307:Risk Factors; D012882:Skin Tests; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D015415:Biomarkers; D007074:Immunoglobulin G; D007073:Immunoglobulin E
keywords: clinical tolerance; desensitization; egg allergy; food allergy; oral immunotherapy; sustained unresponsiveness