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On February 12, 2025, we reported on new data presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress from the phase 3 PEOPLE clinical trial.
The study
The PEOPLE study is an extension of the PEPITES (Peanut EPIT Efficacy and Safety) trial, which assessed the efficacy of daily treatment with the VIASKIN peanut patch containing 250 μg of peanut protein (VP250). PEPITES participants, aged 4 to 11 years, were randomized to either placebo or VP250 for 12 months. Those who completed the study were eligible to enroll in PEOPLE for up to 60 months of open-label treatment. Of the 356 participants in PEPITES, 298 enrolled in PEOPLE, and 87 (29.2%) continued treatment through month 60. At study entry, the mean age was 11.1 years.
The findings
After 60 months of treatment, 73.3% of participants, aged 4 to 11 years, were treatment responders, with two-thirds able to consume 3 to 4 peanuts.
The VIASKIN peanut patch demonstrated a favorable safety profile throughout the 60-month study period, with no reports of severe systemic allergic reactions. Localized skin reactions such as mild erythema or pruritus were the most common adverse events but generally resolved without intervention. The long-term tolerability of the treatment is a crucial factor for patient adherence.
Author's comments
“It is promising that more than 73% of participants were treatment responders, especially in an adolescent patient population, with two-thirds consuming 3 to 4 peanuts at month 60. We know that VIASKIN peanut patch is a well-tolerated product with a promising safety profile, which is further supported by an average treatment compliance of 93% up to 5 years.”
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