Phase III ECZTEND long term study of Adbry shows consistency with other studies in atopic dermatitis.- LEO Pharma
LEO Pharma announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD). The 3.5-year interim safety analysis in more than 1,400 patients from the phase III ECZTEND long-term, open-label extension trial (NCT03587805) showed that the overall safety profile of Adbry 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS) was consistent with that observed in the parent trials of tralokinumab-ldrm, with no new safety signals emerging.
The interim efficacy analysis showed Adbry 300 mg Q2W plus optional TCS demonstrated sustained improvement in extent and severity of atopic dermatitis, itch severity, and quality of life in adult patients treated with Adbry for up to 3 years.
Patients who had enrolled in the parent trials and continued into ECZTEND were on treatment for up to 3.5 years, including up to 2.5 years in ECZTEND and up to one year in the parent trials. From ECZTEND baseline to data cut-off (up to 2.5 years in ECZTEND), 22.9% of patients had withdrawn from the study, and discontinuation rates due to an adverse event (AE) were 2.4%. The most frequently reported AEs (occurring in at least 5% of participants) included viral upper respiratory tract infection (mainly reported as common cold), atopic dermatitis, upper respiratory infection, headache, and conjunctivitis. And in the cohort of 616 patients who received Adbry for up to 3 years, 85.1% achieved at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75). Half of the patients (50.5%) achieved an Investigator Global Assessment score of 0/1 (IGA 0/1), indicating clear or almost clear skin. Interim results were shared as a poster presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting.
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