Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.
2017 Apr
Journal Article
Authors:
Jones, S.M.;
Sicherer, S.H.;
Burks, W.;
Leung, D.Y.M.;
Lindblad, R.W.;
Dawson, P.;
Henning, A.K.;
Berin, C.;
Chiang, D.;
Vickery, B.P.;
Pesek, R.D.;
Cho, C.B.;
Davidson, W.F.;
Plaut, M.;
Sampson, H.A.;
Wood, R.A.
Secondary:
J Allergy Clin Immunol
Volume:
139
Pagination:
1242-1252.e9
Issue:
4
PMID:
28091362
DOI:
10.1016/j.jaci.2016.08.017
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.