Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy.

Matthew Greenhawt*, Sayantani B. Sindher, Julie Wang, Michael Osullivan, George Du Toit, Edwin H. Kim, Deborah Albright, Sara Anvari, Nicolette Arends, Peter D. Arkwright, Philippe Begin, Katharina Blumchen, Thierry Bourrier, Terri Brown-Whitehorn, Heather Cassell, Edmond S. Chan, Christina E. Ciaccio, Antoine Deschildre, Amandine Divaret-Chauveau, Stacy L. DorrisMorna J. Dorsey, Thomas Eiwegger, Michel Erlewyn-Lajeunesse, David M. Fleischer, Lara S. Ford, Maria Garcia-Lloret, Lisa Giovannini-Chami, Jonathan O. Hourihane, Nicola Jay, Stacie M. Jones, Leigh Ann Kerns, Kirsten M. Kloepfer, Stephanie Leonard, Guillaume Lezmi, Jay A. Lieberman, Jeanne Lomas, Melanie Makhija, Christopher Parrish, Jane Peake, Kirsten P. Perrett, Daniel Petroni, Wolfgang Pfutzner, Jacqueline A. Pongracic, Patrick Quinn, Rachel G. Robison, Georgiana Sanders, Lynda Schneider, Hemant P. Sharma, Juan Trujillo, Paul J. Turner, Katherine Tuttle, Julia E. Upton, Pooja Varshney, Brian P. Vickery, Christian Vogelberg, Brynn Wainstein, Robert A. Wood, Katharine J. Bee, Dianne E. Campbell, Todd D. Green, Rihab Rouissi, Aurelie Peillon, Henry T. Bahnson, Timothee Bois, Hugh A. Sampson, A. Wesley Burks

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

41 Scopus citations


Abstract Background No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown. Methods We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo. Results Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group. Conclusions In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE number, NCT03211247.)

Original languageEnglish (US)
Pages (from-to)1755-1766
Number of pages12
JournalNew England Journal of Medicine
Issue number19
StatePublished - 2023


  • Allergy
  • Allergy/Immunology
  • Allergy/Immunology General
  • Pediatrics
  • Pediatrics General

ASJC Scopus subject areas

  • General Medicine


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