LEO Pharma Inc., a leader in medical dermatology, announced the final results of ECZTEND, a five-year study on Adbry® (tralokinumab-ldrm). The study, presented at the Fall Clinical Dermatology Conference in Las Vegas, demonstrated the long-term safety and efficacy of Adbry® in treating moderate-to-severe atopic dermatitis (AD) in adults and adolescents.
ECZTEND, a Phase 3, open-label, single-arm, multi-center, long-term extension study, involved 1672 adult and adolescent participants aged 12 and above. Participants joined ECZTEND after completing treatment with Adbry® in previous trials. The study revealed no new safety concerns after long-term Adbry® use (up to one year in parent trials and up to five years in ECZTEND). The overall safety profile remained consistent with the initial placebo-controlled trials, with most adverse events reported as mild/moderate.
The study also showed that Adbry® provided sustained effectiveness for up to six years. A significant reduction in the Eczema Area and Severity Index (EASI-75) from baseline to Week 248 was observed in 92.9% of participants. Additionally, 66.7% of participants achieved an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1) within the same timeframe. Improvements in itch, sleep, and overall quality of life were also noted.
These findings provide valuable long-term data for healthcare professionals, supporting the sustained use of Adbry® in managing this chronic condition. The detailed results of the ECZTEND study will be published in the peer-reviewed journal, Skin.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
