Scientific Study

Rationale: Previously reported interim results from PEOPLE (PEPITES Open-Label Extension) demonstrated Viaskin Peanut 250 μg (VP250) led to continued treatment response and was well-tolerated out to 3 years. Here we report PEOPLE end-of-study safety results. Methods: In PEPITES, 356 peanut-allergic participants (aged 4-11 years) were randomized to placebo or VP250. In PEOPLE, 298 participants were treated with open-label VP250 for up to 48 (placebo+VP250) or 60 (VP250+VP250) months. Safety outcomes included duration and severity of treatment-emergent adverse events (TEAEs) and serious TEAEs. Results: 87/298 (29.2%) participants continued treatment in the PEOPLE extension period (Years 4 and 5); mean (range) age was 11.1 (8-16) years. During the Extension Period, there were no discontinuations due to TEAEs, or treatment-related serious TEAEs; 1 (1.1%) participant experienced a treatment-related severe TEAE. Treatment-related TEAEs decreased over time: 63/87 (72.4%) in Year 1 to 9/59 (15.3%) in Year 5. Subjects reporting TEAEs leading to systemic or inhaled corticosteroid use decreased from 20/87 (23.0%) in Year 1 to 1/59 (1.7%) in Year 5. Treatment-related anaphylaxis occurred in 2/87 (2.3%) (Years 1 and 2 only). Treatment-related TEAEs leading to epinephrine use occurred in 1/87 (1.1%) participants (Year 1 only). Overall mean treatment compliance remained high out to 5 years (93%). Conclusions: VP250 treatment over 5 years in PEOPLE showed decreasing frequency and severity of TEAEs, no new safety signals, and high treatment compliance. These data suggest long-term VP250 treatment in peanut-allergic children may have a favorable safety and tolerability profile, which may facilitate its use over multiple years of treatment. https://doi.org/10.1016/j.jaci.2023.11.406