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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 69-75 |
| Number of pages | 7 |
| Journal | Journal of Allergy and Clinical Immunology: Global |
| Volume | 2 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 2023 |
Funding
The study was sponsored by DBV Technologies . DBV Technologies was involved in the design and general oversight of the study but not in the collection and management of data; analysis and interpretation of the data included contributions from DBV Technologies–employed and –contracted statisticians; and nonauthor contributors from DBV Technologies were involved in the preparation, review, approval, and decision to submit the manuscript for publication. DBV Technologies did not have the right or ability to veto the authors’ final decision to submit the manuscript for publication. All data were collected electronically, managed, analyzed, and locked by the contract research organization (Parexel International) before being released to the authors. An independent data and safety monitoring board oversaw the study conduct and reviewed blinded and unblinded adverse event data (see this article’s Online Repository available at www.jaci-global.org ). In addition, checks of data integrity were performed by DBV Technologies, which included site visits and site audits, as well as contract research organization oversight.
Keywords
- Epicutaneous immunotherapy
- Viaskin Peanut
- children
- concomitant atopic conditions
- desensitization
- food allergy
- immunotherapy
- peanut allergy
ASJC Scopus subject areas
- Immunology and Allergy