Abstract
What is this summary about? This is a summary of an article published in The New England Journal of Medicine about the EPITOPE clinical study, which tested a skin patch called ViaskinTM Peanut 250 µg (micrograms) as a treatment option for peanut allergy in children aged 1 through 3 years. The patch is a form of epicutaneous immunotherapy (EPIT), which is a new approach to allergen immunotherapy that delivers a small amount of peanut protein to the immune system through the skin. Viaskin Peanut is an investigational therapy, meaning it has not yet been approved by the United States Food and Drug Administration (FDA), that has been studied before in young children aged 4 through 11 years. In those studies, the children who received the patch were desensitized and were less likely to experience anaphylaxis when they ate peanut at the end of the study. The EPITOPE study included children aged 1 through 3 years with peanut allergy and looked at how well the peanut patch worked and how safe it was compared to a patch with no medicine (placebo) after 12 months. What were the key takeaways? The study showed that the peanut patch was better in desensitizing children to peanuts than the placebo patch. Most of the children in the study who received the peanut patch for 12 months (the treatment group) were able to eat and tolerate more peanut at the end of the study than those who received only the placebo patch (the control group). This demonstrates that the children in the treatment group were less likely to have an allergic reaction if they ate peanut by accident at the end of the study. The children in the treatment group also had less severe symptoms when they were given peanut during the oral food challenges at the end of the study. Most children in both groups experienced side effects. Mild to moderate local skin reactions where the patch was applied were most common. These side effects happened less often and were less serious over the 12-month treatment period. What were the main conclusions reported by the researchers? Overall, these results show the peanut patch may be a possible treatment option to help desensitize young children with peanut allergy.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 5-13 |
| Number of pages | 9 |
| Journal | Immunotherapy |
| Volume | 16 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 2024 |
Funding
DRS reports consulting fees from ARS Pharmaceuticals, Novartis, and Kaléo, royalties from Springer Publishing, and honoraria from the American Academy of Pediatrics and the Collegiate and Professional Sports Dietitians Association. RG reports receiving research support from the National Institutes of Health (NIH) (R21 ID # AI135705, R01 ID # AI130348, U01 ID # AI138907), Food Allergy Research & Education (FARE), Melchiorre Family Foundation, Sunshine Charitable Foundation, The Walder Foundation, UnitedHealth Group, Thermo Fisher Scientific, Novartis, and Genentech. RG serves as a medical consultant/advisor for Genentech, Novartis, Aimmune LLC, Allergenis LLC, and Food Allergy Research & Education (FARE), and has ownership interest in Yobee Care, Inc. DM reports being a principal investigator for DBV Technologies and ALK-Abelló, and on the advisory board and a speaker for ALK-Abelló, Bausch Health, and Pfizer. LM reports that her child was a participant in this clinical trial, which was funded by DBV Technologies. DS reports being a principal investigator for DBV Technologies, ALK-Abelló, Novartis, Alladapt Immunotherapeutics, IgGenix, COUR Pharmaceuticals, AstraZeneca, and on the advisory board and a speaker for Regeneron-Sanofi. VHT reports receiving a grant from the Immune Deficiency Foundation, consulting fees from Pharming and Kaléo, and is a speaker for Takeda and CSL, a panel participant for Amgen, an advisory board member for Takeda, Aimmune, Regeneron, Sanofi, Pfizer, Enzyvant, DBV Technologies, US WorldMeds, Kaléo, ARS Pharmaceuticals, and Bryn Pharma, and on the Vice Chair Practice Management Committee for the American Academy of Allergy, Asthma, and Immunology. VHT was a clinical trial investigator for the EPITOPE study. HAS reports consulting fees from N-Fold Technologies, DBV Technologies, Food Allergy Research and Education (FARE), and Siolta Therapeutics, grants to his institution from the National Institute of Allergy and Infectious Diseases and from Allergenis, royalties from Elsevier and Wiley, honoraria from the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology, on the Scientific Advisory Board for Siolta Therapeutics and FARE, and on the Adverse Reaction Adjudication Board for Abbvie. HAS was a clinical trial investigator for the EPITOPE study. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing disclosure
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Oncology