title: Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.
abstract: BACKGROUND
  Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment.
  
  
  OBJECTIVE
  We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy.
  
  
  METHODS
  In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France). The primary outcome was treatment success after 52 weeks, which was defined as passing a 5044-mg protein oral food challenge or achieving a 10-fold or greater increase in successfully consumed dose from baseline to week 52. Adverse reactions and mechanistic changes were assessed.
  
  
  RESULTS
  At week 52, treatment success was achieved in 3 (12%) placebo-treated participants, 11 (46%) VP100 participants, and 12 (48%) VP250 participants (P = .005 and P = .003, respectively, compared with placebo; VP100 vs VP250, P = .48). Median change in successfully consumed doses were 0, 43, and 130 mg of protein in the placebo, VP100, and VP250 groups, respectively (placebo vs VP100, P = .014; placebo vs VP250, P = .003). Treatment success was higher among younger children (P = .03; age, 4-11 vs >11 years). Overall, 14.4% of placebo doses and 79.8% of VP100 and VP250 doses resulted in reactions, predominantly local patch-site and mild reactions (P = .003). Increases in peanut-specific IgG4levels and IgG4/IgE ratios were observed in peanut EPIT-treated participants, along with trends toward reduced basophil activation and peanut-specific TH2 cytokines.
  
  
  CONCLUSIONS
  Peanut EPIT administration was safe and associated with a modest treatment response after 52 weeks, with the highest responses among younger children. This, when coupled with a high adherence and retention rate and significant changes in immune pathways, supports further investigation of this novel therapy.
authors.affiliation: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: JonesStacieM@uams.edu.
authors.forename: Stacie M
authors.initials: SM
authors.lastname: Jones
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Scott H
authors.initials: SH
authors.lastname: Sicherer
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.affiliation: Department of Pediatrics, National Jewish Health, Denver, Colo.
authors.forename: Donald Y M
authors.initials: DY
authors.lastname: Leung
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Lindblad
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Peter
authors.initials: P
authors.lastname: Dawson
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Alice K
authors.initials: AK
authors.lastname: Henning
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: M Cecilia
authors.initials: MC
authors.lastname: Berin
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: David
authors.initials: D
authors.lastname: Chiang
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
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: Robbie D
authors.initials: RD
authors.lastname: Pesek
authors.affiliation: EMMES Corporation, Rockville, Md.
authors.forename: Christine B
authors.initials: CB
authors.lastname: Cho
authors.affiliation: National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.
authors.forename: Wendy F
authors.initials: WF
authors.lastname: Davidson
authors.affiliation: National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.
authors.forename: Marshall
authors.initials: M
authors.lastname: Plaut
authors.affiliation: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Sampson
authors.affiliation: Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wood
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D021183:Peanut Hypersensitivity / Q000628:therapy*; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D000485:Allergens
keywords: IgE; Peanut hypersensitivity; desensitization; epicutaneous; food allergy; immunotherapy