Peanut patch treatment continues to help toddlers safely build tolerance over three years

ORLANDO (Nov. 6, 2025) – New research presented at the 2025 Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) offers encouraging news for parents of young children with peanut allergies. A long-term study found that a peanut patch treatment –  epicutaneous immunotherapy – continued to help toddlers safely build tolerance to peanuts over three years.

The treatment, known as the Viaskin Peanut Patch, delivers small amounts of peanut protein through the skin. The goal is to train the immune system to tolerate peanut exposure and reduce the risk of severe allergic reactions from accidental ingestion.

This new analysis looked at toddlers who originally received placebo in an earlier one-year study and then used the peanut patch for up to three years. After three years of treatment, more than 70% of these children could tolerate the equivalent of at least three to four peanut kernels – a significant improvement from their first year of treatment. Nearly half could tolerate even higher amounts.

Importantly, the treatment continued to show a strong safety record. No cases of treatment-related anaphylaxis (a severe allergic reaction) were reported in the third year. Skin irritation at the patch site – the most common side effect – became less frequent over time. Researchers also found that children’s reactions during food challenges became milder, with fewer severe symptoms after three years than after one year.

“These results show that ongoing treatment with the peanut patch continues to improve tolerance and remains safe over time,” said allergist Matthew Greenhawt, MD, MBA, lead author and ACAAI member. “For parents of toddlers with peanut allergies, this kind of approach may one day offer peace of mind by reducing the risk of having an allergic reaction, including severe reactions,  from accidental exposure.”

Peanut allergy affects about 2% of children in the U.S. and is a leading cause of severe allergic reactions. The study results add to growing evidence that early intervention in young children could help change the course of peanut allergy. Researchers stress that parents should not attempt any form of peanut desensitization at home and should discuss emerging treatment options with a board-certified allergist.

The research was funded by DBV Technologies.

Abstract Title: Long-Term Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Epopex End of Study Results (Full abstract below)

Presenter: Matthew Greenhawt, MD, MBA

For more information about diagnosis and treatment of food allergies, or to find an allergist in your area, visit AllergyandAsthmaRelief.org. The ACAAI Annual Scientific Meeting is Nov. 6-10. For more news and research from the ACAAI Scientific Meeting, go to our newsroom and follow the conversation on X/Twitter #ACAAI25.

About ACAAI

The American College of Allergy, Asthma & Immunology (ACAAI) is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. Founded in 1942, the College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy, and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org. Join us on Facebook, Pinterest, Instagram, Threads and X.

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LONG-TERM EFFICACY AND SAFETY OF EPICUTANEOUS IMMUNOTHERAPY IN PEANUT-ALLERGIC TODDLERS: EPOPEX END OF STUDY RESULTS
M. Greenhawt^*1, J. Wang², G. DuToit³, M. O'Sullivan⁴, T. Brown-Whitehorn⁵, T. Bois⁶, K. Bee⁷, T. Green⁸, H. Sampson², A. Burks⁹, 1. Arlington, VA; 2. New York, NY; 3. London, United Kingdom; 4. Murdoch, WA, Australia; 5. Philadelphia, PA; 6. Châtillon, France; 7. Ridgefield, CT; 8. Summit, NJ; 9. Chapel Hill, NC.

Introduction: In the phase 3 EPITOPE study of epicutaneous immunotherapy with the VIASKIN peanut patch (VP250), 67% of peanut-allergic toddlers were treatment responders (vs 33.5% placebo) after 1 year. Increases in treatment effect and a favorable safety profile were observed over the first 2 years of the open-label extension (OLE). Here we report end-of-study results from the OLE among EPITOPE placebo participants (placebo+VP250).
Methods: After 12 months of VP250 or placebo, participants were eligible to enroll in the OLE for up to 3 total years of treatment, with annual double-blind, placebo-controlled food challenges (DBPCFC) and safety assessments.
Results: Of 266 EPITOPE participants enrolled in the OLE, 91 were in the placebo+VP250 group.; 56/91 underwent Month 36 DBPCFC. After 3 years (M36) of VP250 71.2% of placebo+VP250 participants reached an eliciting dose (ED) ≥1000 mg vs 62.7% after 1 year of treatment (M12). Increases were also observed from M12 to M36 in ED ≥2000 mg (36.5% to 46.0%) and those completing the DBPCFC without meeting stopping criteria (28.4% to 42.0%). Reductions in DBPCFC reaction severity were observed, with 10.0% having severe symptoms at M36 vs 19.2% at M12. No treatment-related anaphylaxis or serious treatment-related adverse events occurred in year 3 of VP250 treatment. Continued decreases in local application-site reactions occurred over time.
Conclusions: Three years of VP250 in 1- 3-year-old peanut-allergic toddlers resulted in continued accumulated treatment benefit without any new safety signals among those initially randomized to placebo in EPITOPE. These results are consistent with outcomes observed after 36 months in VP250-treated EPITOPE participants.