Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial

Abstract

Additional long-term treatments are needed for moderate-to-severe atopic dermatitis (AD). An ongoing, open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses tralokinumab plus optional topical corticosteroids in participants from previous tralokinumab parent trials (PTs) with moderate-to-severe AD. To evaluate the safety and efficacy of up to 2years tralokinumab treatment in a post hoc interim analysis. Safety analyses included adults from completed PTs enrolled in ECZTEND, regardless of tralokinumab exposure duration. Efficacy analyses included adult participants treated with tralokinumab in ECZTEND for ≥1year and subgroup analyses of those on tralokinumab for 2years (1year from PT, 1year in ECZTEND). Primary end point was the number of adverse events with additional efficacy end points. Participants on tralokinumab had an exposure-adjusted rate of 237.8 adverse events/100 patient-years' exposure (N=1174) in the safety analysis set. Exposure-adjusted incidence rates of common adverse events were comparable to PTs, although at lower rates. With 2years of tralokinumab, improvements in extent and severity of AD were sustained, with Eczema Area and Severity Index (EASI-75) in 82.5% of participants (N=345). Possible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND. Over 2years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.