title: Efficacy and safety of high-dose rush oral immunotherapy in persistent egg allergic children: A randomized clinical trial.
abstract: Egg oral immunotherapy is effective but time consuming.
  
  
  
  To assess the efficacy and safety of egg rush oral immunotherapy (ROIT) with a targeted dose equivalent to a raw egg white.
  
  
  
  Thirty-three persistent egg allergic children confirmed by double-blind, placebo-controlled food challenge (DBPCFC) were randomized to receive egg ROIT immediately after randomization (ROIT1 group), or to continue an egg avoidance diet for 5 months after randomization (control group [CG]). A 5-day build-up phase starting with the highest single tolerated dose at baseline DBPCFC was scheduled and several doses administered daily until achieving a dose of approximately 2,808 mg of egg white protein. In the maintenance phase, patients ate an undercooked egg every 48 hours for 5 months. The CG participants who failed the DBPCFC at 5 months began active treatment. Children from the ROIT1 group plus children from the CG who failed a second DBPCFC at 5 months and then received egg ROIT were randomized to the ROIT2 group. Adverse events (AEs) and immune marker evolution were recorded.
  
  
  
  A total of 17 (89%) of 19 children in the ROIT1 group and no CG patients were desensitized at 5 months (P < .001). A total of 31 (97%) of the 32 children in the ROIT2 group completed the build-up phase in a median of 3 days (range, 1-14 days), and 30 (94%) of 32 maintained desensitization at 5 months. From baseline to 5 months of treatment, skin prick test, specific IgE, and specific IgE/IgG4 ratio to egg fractions significantly decreased, whereas specific IgG4 increased. During the build-up phase, AEs occurred in 69% of patients (50% had ≤2 AEs) and 31% of doses (2% severe, 55% gastrointestinal). Lower threshold dose in the DBPCFC and higher egg white and ovalbumin specific IgE levels at baseline revealed an association with a higher rate of AEs.
  
  
  
  The proposed 5-day egg ROIT desensitized 94% of the allergic patients, with most AEs being mild or moderate.
authors.affiliation: Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Pérez-Rangel
authors.affiliation: Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Rodríguez Del Río
authors.affiliation: Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Escudero
authors.affiliation: Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Sánchez-García
authors.affiliation: Unidad de Investigación en Salud Pública, Monterrey, Mexico.
authors.forename: José Javier
authors.initials: JJ
authors.lastname: Sánchez-Hernández
authors.affiliation: Allergy Department, Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Health Research Institute Princesa, Madrid, Spain. Electronic address: mibanezs@salud.madrid.org.
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Ibáñez
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology*; D015415:Biomarkers; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D021181:Egg Hypersensitivity / Q000175:diagnosis / Q000276:immunology* / Q000628:therapy*; 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; D010641:Phenotype; D012307:Risk Factors; D016896:Treatment Outcome; D057188:Workflow
chemical_list: D000485:Allergens; D015415:Biomarkers; D007074:Immunoglobulin G; D007073:Immunoglobulin E