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 IgG4 levels 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: Stacie M Jones, Scott H Sicherer, A Wesley Burks, Donald Y M Leung, Robert W Lindblad, Peter Dawson, Alice K Henning, M Cecilia Berin, David Chiang, Brian P Vickery, Robbie D Pesek, Christine B Cho, Wendy F Davidson, Marshall Plaut, Hugh A Sampson, Robert A Wood, Consortium of Food Allergy Research
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 139 Issue 4 Pg. 1242-1252.e9 (Apr 2017) ISSN: 1097-6825 [Electronic] United States
• PMID: 28091362 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2016 American Academy of Allergy, Asthma & Immunology. All rights reserved.

Chemical References

• Allergens

Topics

• Adolescent
• Adult
• Allergens (administration & dosage)
• Child
• Child, Preschool
• Desensitization, Immunologic (methods)
• Double-Blind Method
• Female
• Humans
• Male
• Peanut Hypersensitivity (therapy)
• Transdermal Patch
• Young Adult