VIASKIN Peanut Patch Efficacy Holds in Kids With Atopic Comorbidities

New data from the Phase 3 VITESSE trial of the VIASKIN Peanut Patch (DBV Technologies) presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026 in Istanbul, Turkey, show that the epicutaneous immunotherapy device produced statistically significant efficacy versus placebo in children aged 4 to 7 years with peanut allergy and ≥ 1 additional atopic condition. Response rates at 12 months ranged from 46.8% to 48.3% across subgroups defined by concomitant asthma, additional food allergies, or atopic dermatitis, all closely tracking the overall responder rate of 46.6% in the patch arm compared with 14.9% for placebo.1

The findings are particularly meaningful given how well the enrolled population mirrors patients seen in real-world allergy practice. In VITESSE, atopic comorbidities were highly prevalent: 61.8% of the 654 randomized participants had atopic dermatitis, 56.6% had ≥ 1 additional food allergy, and 35.8% had asthma. For David Fleischer, MD, director of allergy and immunology at Children's Hospital Colorado, the composition of the trial population was not surprising.

"Most of our patients with food allergy often have atopic dermatitis. Many of them have other food allergies… [or] asthma,” Fleischer said in an interview with HCPLive. “It’s very reassuring to show that the typical patient we're going to see in our clinic was seen in this trial and that patients with these atopic conditions did well.”

The risk difference between the patch and placebo arms was largest in the atopic dermatitis subgroup, at 34.0 percentage points (95% confidence interval [CI], 25.09 to 42.94; response rates: 47.2 vs 13.2%), compared with 33.2 points in the food allergy subgroup (95% CI, 23.50 to 42.83; response rates: 46.8% vs 13.6%) and 28.8 points in the asthma subgroup (95% CI, 15.79 to 41.76; response rates: 48.3% vs 19.6%). Fleischer said the signal in the atopic dermatitis group, while notable, was consistent with the broader understanding of skin-mediated immunologic responses.1

“While we think that atopic dermatitis sets patients up for developing food allergy because they can become sensitized to the skin, the skin can actually desensitize patients, meaning [it] actually [does] what it's supposed to do here by increasing the threshold of the amount that patients can tolerate,” Fleischer said. He added that the data confirm the patch is safe to use in this population and that the localized skin reactions associated with its use are typically self-resolving or manageable with topical steroids.

A recurring theme in Fleischer's assessment was the practical advantages of epicutaneous delivery in a patient population that is already complex to manage. Unlike oral immunotherapy, the VIASKIN Peanut Patch does not require dose holds during illness or exercise restrictions, which Fleischer described as meaningful for families juggling concurrent atopic conditions.

"Throwing a peanut patch, a cutaneous immunotherapy, into your treatment regimen, along with treating your eczema… [or] asthma, is not going to add a significant burden onto what you're already managing," Fleischer said. “It's really an easy product that’s practical and easy to use."

He also acknowledged that patients need to be prepared for a longer timeline to response and that patients need to be patient with the product. Fleischer said that expectation-setting with families is part of appropriate counseling.

Looking ahead, Fleischer said the next steps include publication of the data and submission of a US Food & Drug Administration (FDA) application. DBV Technologies announced in late February that the company plans to submit a biologics license application (BLA) to the FDA this year.2 A separate safety study in children aged 1 to 3 years, requested by the FDA, is also underway. Fleischer said that data, once available, will support an application to extend the indication to that age group.

“Hopefully by next year, 1–7-year-olds will have the opportunity to be treated with a very safe, effective treatment that's very practical for families,” he said.

Editor’s note: Relevant disclosures for Fleischer include DBV Technologies, ARS Pharmaceuticals; UpToDate, Bryn Pharma, Aquestive Therapeutics, Nasus, and Genentech, and Grow Happy.

References

1. Jonathan. DBV Technologies to Present New Positive Data from VITESSE Study and Preview Recently Initiated THRIVE Study at the EAACI Congress 2026 | DBV Technologies. Dbv-technologies.com. Published June 8, 2026. Accessed June 15, 2026. https://dbv-technologies.com/press_releases/dbv-technologies-to-present-new-positive-data-from-vitesse-study-and-preview-recently-initiated-thrive-study-at-the-eaaci-congress-2026/

2. Fleischer D. VIASKIN Peanut Patch Shows Strong Phase 3 VITESSE Results, With David Fleischer, MD. HCPLive. March 23, 2026. Accessed June 15, 2026. https://www.hcplive.com/view/viaskin-peanut-patch-shows-strong-phase-3-vitesse-results-david-fleischer-md