title: Adverse effects during specific oral tolerance induction: in home phase.
abstract: BACKGROUND
  Specific oral tolerance induction (SOTI) is a promising approach for severe food allergies. There are little data in the literature regarding the home-phase of SOTI, not only with regard to type and frequency of adverse reactions but also regarding the most suitable treatment and protocol.
  
  
  OBJECTIVE
  To define the incidence and severity of adverse reactions, possible risk factors, and the safety and effectiveness of the home-phase of an original SOTI protocol in a large group of children with severe cow's milk (CM) allergy, after the hospital "rush" phase.
  
  
  METHODS
  The study was conducted by recording in-home phase adverse events, success and failure as reported by parents, and calling families. Adverse reactions were treated following the International Guidelines, arbitrarily modified by introducing nebulised epinephrine for respiratory reactions, oral beclomethasone for acute gastric pain and oral cromolyn for recurrent gastric pain.
  
  
  RESULTS
  Out of 140 patients, 132 were contacted; eight were inaccessible (follow-up 2-84 months). The number of adverse reactions was 1 in every 100 doses. The reactions were treated with nebulised epinephrine (221 reactions), IM epinephrine (6 reactions), and other drugs. Patients with high specific IgE levels (greater than 100 kU(A)/L) and lower CM dose (less than 5 ml) at the end of in-hospital phase showed a higher risk both for number of reactions and use of nebulised epinephrine.
  
  
  CONCLUSIONS
  The home phase of SOTI was characterised by a significant number of adverse reactions, mostly managed with an acceptable rate of side effects. Nebulised epinephrine played a pivotal role in respiratory reactions.
authors.affiliation: Emergency Department, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, University of Trieste, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Barbi
authors.forename: G
authors.initials: G
authors.lastname: Longo
authors.forename: I
authors.initials: I
authors.lastname: Berti
authors.forename: L
authors.initials: L
authors.lastname: Matarazzo
authors.forename: L
authors.initials: L
authors.lastname: Rubert
authors.forename: A
authors.initials: A
authors.lastname: Saccari
authors.forename: I
authors.initials: I
authors.lastname: Lenisa
authors.forename: L
authors.initials: L
authors.lastname: Ronfani
authors.forename: O
authors.initials: O
authors.lastname: Radillo
authors.forename: A
authors.initials: A
authors.lastname: Ventura
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D004837:Epinephrine / Q000008:administration & dosage; D005260:Female; D005512:Food Hypersensitivity / Q000628:therapy*; D006801:Humans; D007108:Immune Tolerance; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D016269:Milk Hypersensitivity / Q000628:therapy; D009330:Nebulizers and Vaporizers
chemical_list: D000485:Allergens; D007073:Immunoglobulin E; D004837:Epinephrine