title: Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy.
abstract: BACKGROUND
  Although peanut oral immunotherapy (OIT) has been conclusively shown to cause desensitization, it is currently unknown whether clinical protection persists after stopping therapy.
  
  
  OBJECTIVE
  Our primary objective was to determine whether peanut OIT can induce sustained unresponsiveness after withdrawal of OIT.
  
  
  METHODS
  We conducted a pilot clinical trial of peanut OIT at 2 US centers. Subjects age 1 to 16 years were recruited and treated for up to 5 years with peanut OIT. The protocol was modified over time to permit dose increases to a maximum of 4000 mg/d peanut protein. Blood was collected at multiple time points. Clinical end points were measured with 5000-mg double-blinded, placebo-controlled food challenges once specific criteria were met.
  
  
  RESULTS
  Of the 39 subjects originally enrolled, 24 completed the protocol and had evaluable outcomes. Twelve (50%) of 24 successfully passed a challenge 1 month after stopping OIT and achieved sustained unresponsiveness. Peanut was added to the diet. At baseline and the time of challenge, such subjects had smaller skin test results, as well as lower IgE levels specific for peanut, Ara h 1, and Ara h 2 and lower ratios of peanut-specific IgE/total IgE compared with subjects not passing. There were no differences in peanut IgG₄ levels or functional activity at the end of the study.
  
  
  CONCLUSIONS
  This is the first demonstration of sustained unresponsiveness after peanut OIT, occurring in half of subjects treated for up to 5 years. OIT favorably modified the peanut-specific immune response in all subjects completing the protocol. Smaller skin test results and lower allergen-specific IgE levels were predictive of successful outcome.
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC. Electronic address: bvickery@email.unc.edu.
authors.forename: Brian P
authors.initials: BP
authors.lastname: Vickery
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Scurlock
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: Michael
authors.initials: M
authors.lastname: Kulis
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: Pamela H
authors.initials: PH
authors.lastname: Steele
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: Janet
authors.initials: J
authors.lastname: Kamilaris
authors.affiliation: Duke Translational Medicine Institute, Durham, NC.
authors.forename: Jelena P
authors.initials: JP
authors.lastname: Berglund
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: Caitlin
authors.initials: C
authors.lastname: Burk
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Anne
authors.initials: A
authors.lastname: Hiegel
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Suzanna
authors.initials: S
authors.lastname: Carlisle
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Lynn
authors.initials: L
authors.lastname: Christie
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Tamara T
authors.initials: TT
authors.lastname: Perry
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Robbie D
authors.initials: RD
authors.lastname: Pesek
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: Saira
authors.initials: S
authors.lastname: Sheikh
authors.affiliation: Department of Pediatrics, Duke University School of Medicine, Durham, NC.
authors.forename: Yamini
authors.initials: Y
authors.lastname: Virkud
authors.affiliation: Department of Pediatrics, Duke University School of Medicine, Durham, NC.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College, London, United Kingdom.
authors.forename: Mohamed H
authors.initials: MH
authors.lastname: Shamji
authors.affiliation: Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College, London, United Kingdom.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Durham
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors.forename: Stacie M
authors.initials: SM
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
mesh_terms: D055516:2S Albumins, Plant / Q000276:immunology; D000284:Administration, Oral; D000293:Adolescent; D052179:Antigens, Plant / Q000276:immunology; D010367:Arachis / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D006023:Glycoproteins / Q000276:immunology; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007223:Infant; D008565:Membrane Proteins; D021183:Peanut Hypersensitivity / Q000097:blood / Q000276:immunology / Q000628:therapy*; D010940:Plant Proteins / Q000276:immunology; D012882:Skin Tests
chemical_list: D055516:2S Albumins, Plant; D052179:Antigens, Plant; C500889:Ara h 1 protein, Arachis hypogaea; C078642:Ara h II protein, Arachis hypogaea; D006023:Glycoproteins; D008565:Membrane Proteins; D010940:Plant Proteins; D007073:Immunoglobulin E
keywords: DOFC; Desensitization oral food challenge; FAB; Facilitated antigen binding; OFC; OIT; Oral food challenge; Oral immunotherapy; Peanut allergy; SOFC; Sustained unresponsiveness oral food challenge; TF; TS; Treatment failure; Treatment success; desensitization; oral immunotherapy; sustained unresponsiveness; tolerance