Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study)

Authors

• Jacqueline A Pongracic
• Rémi Gagnon
• Gordon Sussman
• Dareen Siri
• Roxanne C Oriel
• Terri F Brown-Whitehorn
• Sara Anvari
• William E Berger
• J Andrew Bird
• Edmond S Chan
• R Sharon Chinthrajah
• Hey J Chong
• Stanley M Fineman
• David M Fleischer
• Erika Gonzalez-Reyes
• Edwin H Kim
• Bruce J Lanser
• Andrew MacGinnitie
• Hemalini Mehta
• Daniel Petroni
• Ned Rupp
• Lynda C Schneider
• Amy M Scurlock
• Lawrence D Sher
• Wayne G Shreffler
• Sayantani B Sindher
• Robert Wood
• William H Yang
• Hugh A Sampson
• Timothée Bois
• Todd D Green
• Dianne E Campbell
• Katharine J Bee
• Philippe Bégin

Language

English

Publication Date

5-1-2025

Journal

The Journal of Allergy and Clinical Immunology: In Practice

DOI

10.1016/j.jaip.2025.02.024

PMID

40023371

Abstract

Background: Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy.

Objective: This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.

Methods: REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months.

Results: Of the 392 participants (male 54.8%; median age 7.2 y) who received at least 1 dose of treatment, 77.8% completed the 36-month active treatment. Mean adherence to treatment was high at 96.4%. Most participants (98.7%) experienced at least 1 treatment-emergent adverse event (TEAE); the majority were mild or moderate and decreased in frequency and severity over time. Most participants (94.6%) experienced at least 1 treatment-related TEAE. Local skin reactions were the most common treatment-related TEAE with the incidence decreasing from year 1 (87.8%) to year 3 (19.2%). Serious treatment-related TEAEs were reported in 2 participants. No specific safety signals were identified in the 14 participants enrolled with a history of severe anaphylaxis (Anaphylaxis Staging System grade 3).

Conclusion: Consistent with previous phase 3 studies, long-term EPIT with VIASKIN peanut patch 250 μg was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446).

Keywords

Humans, Peanut Hypersensitivity, Male, Child, Child, Preschool, Female, Desensitization, Immunologic, Allergens, Double-Blind Method, Arachis, Treatment Outcome, Administration, Cutaneous, Desensitization, Epicutaneous immunotherapy, Food allergy, Immunotherapy, Long-term safety, Peanut allergy, Real-world setting, Children, VIASKIN

Published Open-Access

yes

Recommended Citation

Pongracic, Jacqueline A; Gagnon, Rémi; Sussman, Gordon; et al., "Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study)" (2025). Faculty, Staff and Students Publications. 7652.
https://digitalcommons.library.tmc.edu/baylor_docs/7652