In the REALISE study (ClinicalTrials.gov Identifier: NCT02916446), the safety of epicutaneous immunotherapy (EPIT) with Viaskin Peanut (VP250) was evaluated over 3 years in an analysis that approximated anticipated real-world use. Results of the study are being presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2021 Annual Scientific Meeting, November 4 to 8, in New Orleans.
Notably, the recently completed PEPITES phase 3 trial (ClinicalTrials.gov Identifier: NCT02636699) evaluated the efficacy and safety of VP250. In the current study, researchers sought to assess the safety of VP250 over 3 years in children with peanut allergies. All participants were between 4 and 11 years of age, had a well-documented clinical history of peanut allergy, a skin-prick test of 8 mm or more, and peanut-specific immunoglobulin E of at least kUA/L. There was no requirement for entry food challenges. Individuals with a history of severe peanut anaphylaxis were eligible for study enrollment as well. Participants who were initially randomized to 6 months of treatment with VP250 or placebo were offered VP250 for 3 years in an open-label extension study. Safety and compliance data were obtained from all participants.
A total of 393 children were enrolled in the REALISE study, 294 of whom were randomized to VP250 and 99 of whom were randomized to placebo. Overall, 392 participants received VP250. The median age of the participants was 7.0 years; 3.6% of the children had a history of severe anaphylaxis. The median treatment exposure to VP250 was 1093.0 days; 96.4% compliance with the treatment was reported.
Most of the children experienced at least 1 treatment-emergent adverse event (TEAE), the majority of which were mild (in 97.4% of participants) or moderate (in 70.4% of participants) in intensity and decreased over time. The most common TEAEs were pruritus and application-site erythema. A total of 16 participants experienced 17 anaphylactic reactions, none of which were considered severe and all of which were linked to the use of VP250. Two serious VP250-related TEAEs were reported — 2 anaphylactic reactions, with 1 of them leading to study discontinuation.
The investigators concluded that the use of VP250 in the current study provided further support for its safety. VP250 was generally well tolerated over 36 months, with a reduced intensity and frequency of local and systemic TEAEs observed over time. Compliance among the participants was high.
Disclosure: None of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies.
Brown-Whitehorn T, Bégin P, Gagnon R, et al. REALISE (Real-Life Use and Safety of EPIT) study: 3 year results in peanut-allergic children. Ann Allergy Asthma Immunol. 2021;127:S3-S17:Abstract D030. Presented at: American College of Allergy, Asthma & Immunology (ACAAI) 2021 Annual Scientific Meeting; November 4-8, 2021; New Orleans, Louisiana.
Source: Medical Bag https://www.medicalbag.com/home/news/realise-trial-safety-of-viaskin-peanut-patch-in-children-with-peanut-allergies/