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

Authors: Andrew Blauvelt, Richard G. Langley, J.‐P. Lacour, Darryl Toth, Vivian Laquer, Stefan Beissert, Andreas Wollenberg, Pedro Herranz, Andrew Pink, Ketty Peris, Stine Fangel, Le Gjerum, Joshua Corriveau, Hidehisa Saeki, Richard B. Warren, Eric L. Simpson, Kristian Reich - Journal of the American Academy of Dermatology 2022 cited by 75

BackgroundAdditional 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.ObjectiveTo evaluate the safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis.MethodsSafety 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 ≥1 year and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year in ECZTEND). Primary end point was the number of adverse events with additional efficacy end points.ResultsParticipants 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 2 years 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).LimitationsPossible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND.ConclusionOver 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms. 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 2 years 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 ≥1 year and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year 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 2 years 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 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.