Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities

Carla M Davis; Lars Lange; Kirsten Beyer; David M Fleischer; Lara Ford; Gordon Sussman; Roxanne C Oriel; Jacqueline A Pongracic; Wayne Shreffler; Katharine J Bee; Dianne E Campbell; Todd D Green; Romain Lambert; Aurélie Peillon; Philippe Bégin

doi:10.1016/j.jacig.2022.07.009

Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities

J Allergy Clin Immunol Glob. 2022 Sep 22;2(1):69-75. doi: 10.1016/j.jacig.2022.07.009. eCollection 2023 Feb.

Authors

Carla M Davis¹, Lars Lange², Kirsten Beyer³, David M Fleischer⁴, Lara Ford^{5

6}, Gordon Sussman^{7

8}, Roxanne C Oriel⁹, Jacqueline A Pongracic¹⁰, Wayne Shreffler¹¹, Katharine J Bee¹², Dianne E Campbell¹², Todd D Green^{12

13}, Romain Lambert¹², Aurélie Peillon¹², Philippe Bégin¹⁴

Affiliations

¹ Department of Pediatrics, Immunology, Allergy and Retrovirology Section, Baylor College of Medicine, Houston, Tex.
² Department of Pediatrics, St. Marien Hospital Bonn, Bonn, Germany.
³ Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitatsmedizin Berlin, Berlin, Germany.
⁴ Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo.
⁵ Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, Australia.
⁶ Discipline of Child and Adolescent Health, University of Sydney School of Medicine, Sydney, Australia.
⁷ Division of Clinical Immunology and Allergy, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁸ Gordon Sussman Clinical Research, Toronto, Ontario, Canada.
⁹ Department of Pediatrics, Division of Allergy & Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.
¹⁰ Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
¹¹ Food Allergy Center, Departments of Pediatrics and Medicine, Massachusetts General Hospital, Boston, Mass.
¹² DBV Technologies SA, Montrouge, France.
¹³ UPMC Children's Hospital of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pa.
¹⁴ Oral Immunotherapy Clinic, CHU Sainte-Justine, Montreal, Quebec, Canada.

Abstract

Background: Co-occurring atopic conditions are common in children with peanut allergy. As such, it is important to examine the safety and efficacy of epicutaneous immunotherapy with Viaskin Peanut 250 μg patch (VP250) in peanut-allergic children with these conditions.

Objective: We sought to compare efficacy and safety of VP250 versus placebo in peanut-allergic children with/without ongoing atopic conditions at baseline, including asthma, atopic dermatitis/eczema, or concomitant food allergy.

Methods: A subgroup analysis of peanut-allergic children aged 4 to 11 years enrolled in PEPITES (12 months) and REALISE (6 months) randomized, placebo-controlled, phase 3 trials was conducted. The efficacy outcome measure was the difference in prespecified responder rate between placebo and VP250 groups at month 12 based on eliciting dose of peanut protein using double-blind, placebo-controlled food challenge in PEPITES. Safety profiles were evaluated by baseline concomitant disease subgroup in all randomized subjects who received 1 or more dose of the study drug in PEPITES and REALISE pooled data.

Results: Responder rates were significantly (P < .05, all comparisons) greater with VP250 compared with placebo treatment regardless of whether subjects had other atopic conditions. Safety and tolerability profiles were generally similar across subgroups, with no new safety concerns detected. A trend for both higher responder rates and rates of local reactions was observed in subjects with baseline atopic dermatitis versus those without. In subjects with concomitant food allergy at baseline, higher rates of treatment-emergent adverse events, but not study discontinuations or overall rates of anaphylaxis, were observed.

Conclusions: The results support the safety and efficacy of VP250 for treating peanut-allergic children with or without concomitant atopic conditions.

Keywords: Epicutaneous immunotherapy; Viaskin Peanut; children; concomitant atopic conditions; desensitization; food allergy; immunotherapy; peanut allergy.