The long-term safety and tolerability of DBV712 (Viaskin; DBV Technologies) in children aged 4 through 11 years with peanut allergy have been observed, according to findings from the phase 3 PEOPLE study extension safety period.
Presented at the 2024 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting held in Washington, DC from February 23-26, 2024, the data was featured in a poster presentation titled “Long-Term Safety Results of Epicutaneous Immunotherapy (EPIT) With Viaskin Peanut in Peanut-Allergic Children Aged 4 Through 11 Years in the Phase 3 PEOPLE Study” (#379).
The study investigates DBV712’s potential as a treatment for peanut allergy, utilizing a novel approach to epicutaneous immunotherapy (EPIT) with a patch-based platform containing 250 μg peanut protein administered to intact skin to induce desensitization.
The PEOPLE study, an open-label trial, aimed to evaluate the long-term safety and efficacy of children previously enrolled in the PEPITES study, which included 365 peanut-allergic children aged 4 to 11 years. Of this cohort, 298 children continued in the PEOPLE study across 31 sites in Australia, Canada, Europe, and the United States.
Interim 3-year data from the PEOPLE study indicated that among individuals who completed 3 years of DBV712 treatment, 51.8% achieved an eliciting dose (ED) ≥1000 mg peanut protein at Month 36 compared to 40.4% at Month 12 double-blind, placebo-controlled food challenge (DBPCFC).
The peanut patch demonstrated overall tolerability, with a decrease in frequency and severity of application-site reactions over time. Treatment adherence over 3 years was high at 98.1%.
For the extension safety period analysis, data from Years 4 and 5 of the PEOPLE study were utilized. The duration and severity of treatment-emergent adverse events (TEAEs) and serious TEAEs were assessed, with skin reactions graded from 0 to 4.
Of the 217 participants who completed PEOPLE at Year 3, 87 continued in the extension period. The majority of TEAEs were local application reactions, predominantly mild or moderate in severity.
Throughout the study, only one serious treatment-related adverse event occurred in Year 1, and no permanent study discontinuations were attributed to TEAEs. Treatment-related anaphylactic reactions were reported in Years 1 and 2, and treatment-related epinephrine use decreased over time.
Approximately 93% of participants experienced a treatment-related TEAE, with a decreasing trend in frequency and severity over 5 years.
David M. Fleischer, MD, director of the Allergy and Immunology Center at Children’s Hospital Colorado and study author, emphasized the high safety profile of DBV712, along with its efficacy and ease of use, making it an attractive potential treatment option for patients, families, and clinicians.
In conclusion, the data suggest that long-term treatment with DBV712 in children with peanut allergy maintains a favorable safety and tolerability profile, supporting high treatment compliance over multiple years.
