Stacie M Jones1, Scott H Sicherer2, A Wesley Burks3, Donald Y M Leung4, Robert W Lindblad5, Peter Dawson5, Alice K Henning5, M Cecilia Berin2, David Chiang2, Brian P Vickery3, Robbie D Pesek6, Christine B Cho5, Wendy F Davidson7, Marshall Plaut7, Hugh A Sampson2, Robert A Wood8. 1. Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. Electronic address: JonesStacieM@uams.edu. 2. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. 3. Department of Pediatrics, University of North Carolina, Chapel Hill, NC. 4. Department of Pediatrics, National Jewish Health, Denver, Colo. 5. EMMES Corporation, Rockville, Md. 6. Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark. 7. National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md. 8. Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
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.
RCT Entities:
BACKGROUND:Peanutallergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanutallergy treatment. OBJECTIVE: We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanutallergy. METHODS: In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanutallergy (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: David Chiang; Xintong Chen; Stacie M Jones; Robert A Wood; Scott H Sicherer; A Wesley Burks; Donald Y M Leung; Charuta Agashe; Alexander Grishin; Peter Dawson; Wendy F Davidson; Leah Newman; Robert Sebra; Miriam Merad; Hugh A Sampson; Bojan Losic; M Cecilia Berin Journal: J Allergy Clin Immunol Date: 2018-01-31 Impact factor: 10.793
Authors: Charuta Agashe; David Chiang; Alexander Grishin; Madhan Masilamani; Stacie M Jones; Robert A Wood; Scott H Sicherer; A Wesley Burks; Donald Y M Leung; Peter Dawson; Hugh A Sampson; M Cecilia Berin Journal: J Immunol Methods Date: 2017-06-16 Impact factor: 2.303