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

Blauvelt, Andrew; Langley, Richard G.; Lacour, Jean-Philippe; Toth, Darryl; Laquer, Vivian; Beissert, Stefan; Wollenberg, Andreas; Herranz, Pedro; Pink, Andrew E.; Peris, Ketty; Fangel, Stine; Gjerum, Le; Corriveau, Joshua; Saeki, Hidehisa; Warren, Richard B.; Simpson, Eric und Reich, Kristian (2022): 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. In: Journal of the American Academy of Dermatology, Bd. 87, Nr. 4: S. 815-824

Abstract

Background: 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. Objective: To evaluate the safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis. Methods: 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. Results: 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). Limitations: Possible selection bias;no placebo arm;some participants experienced treatment gaps between PTs and ECZTEND. Conclusion: Over 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0190-9622
• Sprache: Englisch