Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.

Publication Type
Journal Article
Year of Publication
2017
Authors
Jones, Stacie M; Sicherer, Scott H; Burks, A Wesley; Leung, Donald Y M; Lindblad, Robert W; Dawson, Peter; Henning, Alice K; Berin, M Cecilia; Chiang, David; Vickery, Brian P; Pesek, Robbie D; Cho, Christine B; Davidson, Wendy F; Plaut, Marshall; Sampson, Hugh A; Wood, Robert A; Consortium of Food Allergy Research
Secondary
J Allergy Clin Immunol
Volume
139
Pagination
1242-1252.e9
Date Published
2017 Apr
Keywords
Adolescent; Adult; allergens; Child; Child, Preschool; Desensitization, Immunologic; Double-Blind Method; Female; Humans; Male; Peanut Hypersensitivity; Transdermal Patch; Young Adult
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 IgG levels and IgG/IgE ratios were observed in peanut EPIT-treated participants, along with trends toward reduced basophil activation and peanut-specific T2 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.