Long-term safety of VIASKIN® Peanut Patch in 4-11-year-old children
Published online February 27, 2025
Peanut allergy is one of the most common food allergies among children. While it has become increasingly prevalent, peanut allergy is typically not outgrown. Current approved treatment options are limited and highlight the need for new therapies that are practical, easy to use, and well tolerated over multiple years of use. Epicutaneous immunotherapy with the VIASKIN® peanut patch containing 250 µg peanut protein (VP250) is a potential peanut allergy treatment in clinical development that introduces a small amount of peanut allergen (approximately 1/1000 of 1 peanut kernel) onto intact skin to induce desensitization. By targeting the specialized immune cells of the skin, there is limited entry of peanut allergen to the bloodstream, thereby decreasing the risk of systemic allergic reactions. The phase 3 clinical trial REALISE assessed the long-term safety of VP250 in peanut-allergic children aged 4 through 11 years.
In a recent article in The Journal of Allergy and Clinical Immunology: In Practice, Pongracic et al. described the long-term results of REALISE. This large, phase 3 study in nearly 400 children included a 6-month period where participants received either VP250 or placebo, followed by a period where all eligible participants received VP250 for up to a total of 3 years of treatment. The study was designed to mirror anticipated real-world use of VP250, meaning that participants who met pre-specified diagnostic criteria for peanut allergy were not required to complete a double-blind, placebo-controlled food challenge to enter the study. This approach allowed children with a history of severe peanut anaphylaxis to be included. Safety was assessed by the investigators according to frequency, duration, severity, and treatment-relatedness of treatment-emergent adverse events.
Based on the results of this study, the investigators concluded that long-term treatment with VP250 under conditions that approximated anticipated real-world use was well tolerated in peanut-allergic children aged 4 through 11 years. The safety results were consistent with prior phase 3 studies of VP250 in children, with the most common adverse events being local skin reactions at the site of patch application, which decreased in frequency (Year 1: 87.8%, Year 3: 19.2%) and severity over time. During 3 years of VP250 treatment, there were low rates of treatment-related anaphylaxis, epinephrine use, and discontinuations, and a high treatment adherence rate (96.4%). The results indicate the potential for real-world use of VP250 over multiple years and support its use as a treatment option for peanut allergy in children, if approved.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAI, focusing on practical information for the practicing clinician.
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