LEO Pharma has shared final results from a long-term extension study of its atopic dermatitis (AD) drug Adbry (tralokinumab-ldrm) in adult and adolescent patients aged 12 years and older with moderate-to-severe cases of the condition.

The phase 3 ECZTEND study evaluated Adbry, marketed for AD outside of the US under the brand name Adtralza, for up to five years in patients who completed their treatment with the drug in one of nine parent trials.

The data presented at the Fall Clinical Dermatology Conference showed that Adbry demonstrated sustained efficacy after up to one year in the parents trials plus up to five years in ECZTEND.

A reduction of at least 75% in Eczema Area and Severity Index from baseline to week 248 was observed in 92.9% of patients, and 66.7% achieved an Investigator’s Global Assessment score of clear or almost clear in the same period. Improvements in Itch, sleep and quality of life were also observed.

No new safety signals were identified, and the overall long-term safety profile was similar to that observed in the initial placebo-controlled treatment period of the parent trials.

Affecting over 26 million people in the US, AD is an inflammatory skin disease characterised by intense itch and eczematous lesions.

Adbry is designed to bind to and inhibit the interleukin-13 cytokine, which plays a role in the immune and inflammatory processes underlying AD.

Brian Hilberdink, executive vice president and president, region North America, LEO, said: “With the release of the final results from the ECZTEND open-label extension study, we are pleased to present robust evidence further supporting the long-term safety and efficacy of [Adbry] in the treatment of moderate-to-severe AD.”

International coordinating investigator of the ECZTEND trial, Andrew Blauvelt, Blauvelt Consulting, added that the long-term findings are “crucial for clinical practice, providing healthcare professionals with the data needed to prescribe [Adbry] for sustained use confidently”.