Peer-reviewed article
Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results
Jacqueline A. Pongracic, Rémi Gagnon, Gordon Lloyd Sussman, Dareen D. Siri, Roxanne Carbonell Oriel et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This clinical trial tested the safety of epicutaneous immunotherapy (a patch containing peanut protein) in children aged 4–11 years with peanut allergies. Nearly 400 children received the patch daily or placebo for 6 months. Most children experienced minor skin reactions at the patch site, but only 4 children stopped treatment due to adverse effects, and epinephrine was needed in only 7 children for allergic reactions. The treatment appeared safe and well-tolerated even in children with a history of severe peanut anaphylaxis.
Key points
- 393 children aged 4–11 years with diagnosed peanut allergy were randomized to receive VP250 patch or placebo for 6 months
- 72.3% of children had a history of peanut anaphylaxis
- All children on VP250 and 83.8% on placebo reported at least one local skin reaction, with frequency decreasing over time
- Only 4 children (1.4%) on VP250 discontinued due to adverse events; epinephrine was administered in 7 children (2.4%)
- No severe anaphylaxis was reported; adverse event rates were similar regardless of history of anaphylaxis
Limitations
The report focuses only on the 6-month randomized controlled phase and does not provide long-term safety data from the extended open-label treatment period. The study does not evaluate whether the patch actually reduces peanut allergy symptoms or improves quality of life, only whether it is safe to use.
Abstract
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Epicutaneous immunotherapy using daily patch containing 250-μg peanut protein (Viaskin Peanut 250 μg)
- Population
- Children aged 4–11 years with physician-diagnosed peanut allergy (393 randomized; 72.3% with history of peanut anaphylaxis)
Key finding
Only 1.4% (4 children) discontinued VP250 due to adverse events