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The problem
Intervention: Epicutaneous immunotherapy using daily patch containing 250-μg peanut protein (Viaskin Peanut 250 μg)
Who it was tested with: Children aged 4–11 years with physician-diagnosed peanut allergy (393 randomized; 72.3% with history of peanut anaphylaxis).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"REALISE is a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, placebo-controlled period followed by open-label active treatment"; this randomized controlled design with a placebo comparator provides strong evidence for safety assessment in a real-world-like setting.
The study only reports safety outcomes over 6 months and does not evaluate efficacy in desensitizing children to peanut or reducing allergic reactions to peanut ingestion. Parent-reported diary data for local skin reactions may be subject to reporting bias.
Across countries and designs
3 studies · 9 countries
