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Enhanced benefit with long-term treatment using the VIASKIN® Peanut Patch

Published online February 14, 2025

Peanut allergy is often diagnosed in early childhood, is typically a lifelong condition, and has become more prevalent over the past 25 years. Currently, treatment options are limited, with most patients still choosing strict avoidance. The average age of diagnosis for peanut allergy has shifted younger, with data suggesting a particularly favorable and safe response to immunomodulatory treatments in infants and young children. This highlights the importance of developing new treatment options for very young children with peanut allergy. One new potential option currently under clinical investigation is epicutaneous immunotherapy with the VIASKIN® peanut patch (VP250). VP250 introduces a small amount of allergen (250 µg of peanut protein, or approximately 1/1000 of 1 peanut kernel) to intact skin to trigger desensitization, decreasing the risk of an allergic reaction. In the phase 3 EPITOPE clinical trial, two-thirds (67%) of peanut-allergic children aged 1 through 3 years (at the start of treatment) were treatment responders after 1 year of treatment, compared with 33.5% in the placebo group. Results of this study showed that VP250 was well tolerated; the most common adverse events were mild skin reactions at the site of patch application. Importantly, the proportion of severe reactions during food challenges decreased from baseline to the end of the study period. All eligible participants who successfully completed EPITOPE were invited to participate in the open-label extension (OLE) study, EPOPEX, where they received VP250 for a total of at least 36 months of treatment.

In a recent article in The Journal of Allergy and Clinical Immunology: In Practice, Greenhawt et al. describe the interim efficacy and safety results from the first year of the EPITOPE OLE. The OLE population included those who initially received VP250 in EPITOPE and received a second year of treatment in the OLE (VP250+VP250 group), as well as those who initially received placebo in EPITOPE and then received their initial year of VP250 in the OLE (placebo+VP250 group). Efficacy was assessed after the first year of the OLE (Month 24) according to eliciting dose (ED, the amount of peanut that triggers a reaction meeting the pre-specified symptom scoring criteria) during a double-blind, placebo-controlled food challenge. Safety was assessed by the investigators by evaluating adverse events, which were characterized according to severity, seriousness, duration, and relationship to treatment.

The treatment benefit previously demonstrated after 1 year in EPITOPE increased with a second year of VP250 treatment. At Month 24, 81.3% of participants reached an ED ≥1000 mg (the equivalent of 3-4 peanut kernels), 63.8% reached an ED ≥2000 mg (the equivalent of 6-8 peanut kernels), and 55.9% completed the food challenge without meeting stopping criteria (the equivalent of 12-14 peanut kernels). Moreover, the severity of observed allergic reactions occurring during the Month 24 food challenge decreased compared to Month 12 (which had already decreased compared with baseline), with more than half (58.4%) of participants experiencing no or mild symptoms (vs 37.4% at Month 12). There were no cases of treatment-related anaphylaxis or serious treatment-related adverse events during the second year of VP250 treatment. All participants experienced mild to moderate patch site reactions, which decreased in frequency over time. For the placebo+VP250 group, the efficacy results mirrored the EPITOPE 250 group, with one case of treatment-related anaphylaxis observed. Overall, VP250 was well tolerated, and treatment adherence rates were high. Based on the results of this interim analysis, the authors concluded that VP250 provides increased benefit beyond 1 year of treatment and may be a safe and effective treatment option for children with peanut allergy, if approved.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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