التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
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, Reich, Kristian |
| المصدر: |
Journal of the American Academy of Dermatology; Oct2022, Vol. 87 Issue 4, p815-824, 10p |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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