LEO Pharma has announced final results from the ECZTEND long-term extension study, showcasing the sustained efficacy and safety of Adbry (tralokinumab-ldrm) in treating adult and adolescent patients (12 years and older) with moderate-to-severe atopic dermatitis (AD). The study, which followed patients for up to five years, provides crucial data for healthcare professionals managing this chronic condition.
The phase 3 ECZTEND study evaluated Adbry, also marketed as Adtralza outside the US, in patients who had completed treatment in one of nine parent trials. The data, presented at the Fall Clinical Dermatology Conference, revealed that Adbry maintained its efficacy for up to one year in the initial trials and for up to five years in the ECZTEND extension.
Sustained Clinical Improvement
The study demonstrated that 92.9% of patients achieved at least a 75% reduction in the Eczema Area and Severity Index (EASI 75) from baseline to week 248. Furthermore, 66.7% of patients achieved an Investigator’s Global Assessment (IGA) score of clear or almost clear during the same period. Patients also reported improvements in itch, sleep quality, and overall quality of life.
Safety Profile
The long-term safety profile of Adbry remained consistent with that observed in the initial placebo-controlled treatment periods of the parent trials. No new safety signals were identified, reinforcing the drug's favorable risk-benefit profile for extended use.
Addressing a Significant Unmet Need
Atopic dermatitis affects over 26 million people in the US and is characterized by intense itch and eczematous lesions. Adbry is designed to specifically target and inhibit the interleukin-13 (IL-13) cytokine, a key driver of the immune and inflammatory processes underlying AD.
Brian Hilberdink, executive vice president and president, region North America, LEO Pharma, stated, "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."
Andrew Blauvelt, international coordinating investigator of the ECZTEND trial from Blauvelt Consulting, emphasized the importance of these findings for clinical practice, stating that the long-term data provides healthcare professionals with the confidence to prescribe Adbry for sustained use, ultimately improving their ability to manage this debilitating condition and enhance patient care.
