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Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results. The journal of allergy and clinical immunology. In practice Pongracic, J. A., Gagnon, R., Sussman, G., Siri, D., Oriel, R. C., Brown-Whitehorn, T., Green, T. D., Campbell, D. E., Anvari, S., Berger, W. E., Bird, J. A., Chan, E. S., Cheema, A., Chinthrajah, S., Chong, H., Dowling, P. J., Fineman, S. M., Fleischer, D. M., Gonzalez-Reyes, E., Kim, E. H., Lanser, B. J., MacGinnitie, A., Mehta, H., Petroni, D., Rupp, N., Schneider, L. C., Scurlock, A. M., Sher, L. D., Shreffler, W. G., Sindher, S. B., Stillerman, A., Wood, R., Yang, W. H., Bois, T., Sampson, H. A., Begin, P. 2021

Abstract

BACKGROUND: Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-mug peanut protein (Viaskin Peanut 250 mug [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: 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 due to adverse events. 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 adverse event rates were similar among participants with and without 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.

View details for DOI 10.1016/j.jaip.2021.11.017

View details for PubMedID 34848381