LEO Pharma Inc.’s tralokinumab (Adbry) demonstrated safety and efficacy in adults and adolescent patients with moderate-to-severe atopic dermatitis (AD) for up to five years, according to the final results from the ECZTEND extension study.
Interim analyses have previously demonstrated the safety and efficacy of the interleukin (IL)-13 blocker in patients followed up to 4.5 years in ECZTEND. The final five-year results were presented for the first time at Fall Clinical 2024 in Las Vegas, NV.
“These long-term findings are crucial for clinical practice, providing healthcare professionals with the data needed to prescribe tralokinumab-ldrm for sustained use confidently,” says study author Andrew Blauvelt, MD, of Blauvelt Consulting, LLC in Lake Oswego, OR. “Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care.”
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 the safety profile observed in the initial placebo-controlled treatment period of the parent trials. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild/moderate.
Long-term treatment with tralokinumab-ldrm also demonstrated sustained efficacy after up to six years of treatment. A reduction of at least 75% in Eczema Area and Severity Index (EASI-75) from baseline to Week 248 was observed in 92.9% of patients. In the same period, 66.7% of patients achieved an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1). Improvements in itch, sleep, and quality of life were observed.
The ECZTEND abstract and poster will also be published in Skin at a later date.
