LEO Pharma reveals final long-term results for Adbry in atopic dermatitis

LEO Pharma has unveiled the final results from a long-term extension study of its atopic dermatitis (AD) medication, Adbry (tralokinumab-ldrm), targeting adult and adolescent patients aged 12 and above who suffer from moderate-to-severe forms of this condition.

The phase 3 ECZTEND study focused on assessing the safety and effectiveness of Adbry, which is known outside the United States as Adtralza, over a duration of up to five years. This study included patients who had already completed their treatment with Adbry in one of nine earlier parent trials. The recent data, presented at the Fall Clinical Dermatology Conference, revealed that Adbry maintained its efficacy for up to one year during the parent trials and extended to five years within the ECZTEND study.

The study's findings highlighted significant improvements, with 92.9% of patients experiencing a reduction of at least 75% in the Eczema Area and Severity Index from baseline to week 248. Furthermore, 66.7% of the participants attained an Investigator’s Global Assessment score of clear or almost clear over the same period. Patients also reported enhancements in itch relief, sleep quality, and overall quality of life.

The safety profile of Adbry remained consistent, with no new safety concerns identified during the long-term study. The overall long-term safety was comparable to the initial placebo-controlled treatment phase of the parent trials.

Atopic dermatitis, which affects over 26 million individuals in the United States, is an inflammatory skin disorder characterized by intense itching and the presence of eczematous lesions. Adbry works by binding to and inhibiting the interleukin-13 cytokine, which plays a crucial role in the immune and inflammatory processes associated with AD.

Brian Hilberdink, Executive Vice President and President for Region North America at LEO Pharma, expressed satisfaction with the release of the final results from the ECZTEND study. He emphasized the strong evidence supporting the long-term safety and efficacy of Adbry in treating moderate-to-severe AD. Hilberdink remarked, "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."

Andrew Blauvelt, the International Coordinating Investigator of the ECZTEND trial and representative of Blauvelt Consulting, underscored the importance of these long-term findings for clinical practice. He noted that the comprehensive data equips healthcare professionals with the necessary information to confidently prescribe Adbry for sustained use. Blauvelt added, "Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care."

These results follow closely on the heels of another significant development for LEO Pharma. Just one month prior, the European Commission approved LEO Pharma's Anzupgo (delgocitinib) cream. This approval is aimed at treating adults with moderate-to-severe chronic hand eczema, particularly for those who find topical corticosteroids inadequate or unsuitable.