Final results from the ECZTEND trial, a five-year extension study, demonstrate the long-term safety and efficacy of Adbry® (tralokinumab-ldrm) in adults and adolescent patients (aged 12 years and over) with moderate-to-severe atopic dermatitis (AD). Presented at the Fall Clinical Dermatology Conference, the findings offer robust evidence supporting the sustained benefits of tralokinumab-ldrm in managing this chronic condition. The study identified no new safety signals and showed lasting improvements in disease severity and quality of life.
ECZTEND Trial Design and Key Findings
The ECZTEND trial was a Phase 3, open-label, single-arm, multi-center, long-term extension study involving 1672 patients with moderate-to-severe AD. Participants had previously completed treatment with tralokinumab-ldrm in one of nine parent trials. The study evaluated the long-term safety and efficacy of tralokinumab-ldrm over a period of up to five years.
Results from the long-term use of tralokinumab-ldrm, up to one year in parent trials plus up to five years in ECZTEND, identified no new safety signals. The overall long-term safety profile was similar to that observed in the initial placebo-controlled treatment periods of the parent trials. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild or moderate.
Sustained Efficacy Over Six Years
Long-term treatment with tralokinumab-ldrm demonstrated sustained efficacy, with 92.9% of patients achieving at least a 75% reduction in Eczema Area and Severity Index (EASI-75) from baseline to Week 248. Additionally, 66.7% of patients achieved an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1) during the same period. Improvements in itch, sleep, and quality of life were also observed.
Implications for Atopic Dermatitis Treatment
The ECZTEND trial provides crucial data for healthcare professionals, supporting the long-term use of tralokinumab-ldrm in managing moderate-to-severe atopic dermatitis. “These long-term findings are crucial for clinical practice, providing healthcare professionals with the data needed to prescribe tralokinumab-ldrm for sustained use confidently,” said Dr. Andrew Blauvelt, Blauvelt Consulting, LLC, and International Coordinating Investigator (ICI) of the ECZTEND trial. “Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care.”
The availability of a single-dose autoinjector for adults in the U.S. further empowers patients to manage their symptoms effectively over the long term. These findings underscore LEO Pharma's commitment to improving the lives of individuals affected by atopic dermatitis.
