Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

Jacqueline A. Pongracic, Rémi Gagnon, Gordon Sussman, Dareen Siri, Roxanne C. Oriel, Terri F. Brown-Whitehorn, Todd D. Green, Dianne E. Campbell, Sara Anvari, William E. Berger, J. Andrew Bird, Edmond S. Chan, Amarjit Cheema, R. Sharon Chinthrajah, Hey Jin Chong, Paul J. Dowling, Stanley M. Fineman, David M. Fleischer, Erika Gonzalez-Reyes, Edwin H. KimBruce J. Lanser, Andrew MacGinnitie, Hemalini Mehta, Daniel Petroni, Ned Rupp, Lynda C. Schneider, Amy M. Scurlock, Lawrence D. Sher, Wayne G. Shreffler, Sayantani B. Sindher, Allan Stillerman, Robert Wood, William H. Yang, Timothée Bois, Hugh A. Sampson, Philippe Bégin

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Background: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children. Objective: To examine the safety of VP250 in children, using a study design approximating potential real-world use. Methods: REAL LIfe Use and Safety of EPIT (REALISE) is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment. Children aged 4 to 11 years with physician diagnosis of peanut allergy received daily treatment with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, randomized, controlled phase of REALISE are reported. Results: Three hundred ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. According to parent diary, all participants receiving VP250 and 83.8% receiving placebo reported at least 1 episode of local skin reaction, with frequency decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued because of adverse events (AEs). Epinephrine was administered for allergic reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the study; none involved severe anaphylaxis. Overall, AE rates were similar among participants with and without a history of peanut anaphylaxis. Conclusions: In a study designed to mirror real-world use, VP250 was observed to be well tolerated in peanut-allergic children, consistent with previous phase 2b and 3 studies.

Original languageEnglish (US)
JournalJournal of Allergy and Clinical Immunology: In Practice
StateAccepted/In press - 2022


  • Children
  • Desensitization
  • Epicutaneous immunotherapy (EPIT)
  • Food allergy
  • Immunotherapy
  • Peanut allergy
  • Real-world setting

ASJC Scopus subject areas

  • Immunology and Allergy


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