title: Safety profile of oral immunotherapy with cow's milk and hen egg: A 10-year experience in controlled trials.
abstract: BACKGROUND
  Oral immunotherapy (OIT) for food allergy is gaining interest due to the favorable clinical results reported with cow's milk, hen egg and peanut. The safety of the procedure remains a critical aspect that can limit the introduction of OIT in clinical practice.
  
  
  OBJECTIVE
  We described herein, in detail, the occurrence and characteristics of adverse events (AE) with OIT in children who participated in controlled trials at our unit.
  
  
  METHODS
  The clinical records of 68 children who received active treatment (40 for cow's milk and 28 for hen egg) were carefully reviewed. The inclusion and exclusion criteria, and the grading of AEs were the same across the trials. Of the 68 children involved, 6 (9%) had to discontinue the OIT procedure due to severe AEs. Fifty percent of the children underwent the buildup and maintenance phases without AEs. Mild-to-moderate AEs were documented in 28 patients, who could complete the desensitization. The majority of reactions were mild or moderate, occurred during an acute intercurrent illness and required only symptomatic treatment.
  
  
  CONCLUSIONS
  A careful review of the patients who received food OIT in controlled trials confirmed that AEs were not rare but that ∼90% of children could achieve an effective desensitization. The procedure remains investigational and should be performed only by trained physicians, especially in the pediatric setting.
authors.affiliation: Pediatric Allergy Unit, University of Messina, Messina, Italy.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Pajno
authors.forename: Lucia
authors.initials: L
authors.lastname: Caminiti
authors.forename: Fernanda
authors.initials: F
authors.lastname: Chiera
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Crisafulli
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Salzano
authors.forename: Stefania
authors.initials: S
authors.lastname: Arasi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Passalacqua
mesh_terms: D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D000818:Animals; D002417:Cattle; D002648:Child; D002675:Child, Preschool; D018849:Controlled Clinical Trials as Topic; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods; D004531:Eggs / Q000009:adverse effects; D005260:Female; D005512:Food Hypersensitivity / Q000276:immunology* / Q000628:therapy*; D006801:Humans; D008297:Male; D008892:Milk / Q000009:adverse effects; D016269:Milk Hypersensitivity / Q000276:immunology / Q000628:therapy; D016896:Treatment Outcome
chemical_list: D000485:Allergens