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.

Blauvelt, A., Langley, R. G., Lacour, J. -., Toth, D., Laquer, V., Beissert, S., Wollenberg, A., Herranz, P., Pink, A. E., Peris, K., Fangel, S., Gjerum, L., Corriveau, J., Saeki, H., Warren, R. B., Simpson, E., Reich, K., 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, <<JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY>>, 2022; 87 (4): 815-824. [doi:10.1016/j.jaad.2022.07.019] [https://hdl.handle.net/10807/229028]

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

Peris, Ketty;
2022

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.
2022
Inglese
Blauvelt, A., Langley, R. G., Lacour, J. -., Toth, D., Laquer, V., Beissert, S., Wollenberg, A., Herranz, P., Pink, A. E., Peris, K., Fangel, S., Gjerum, L., Corriveau, J., Saeki, H., Warren, R. B., Simpson, E., Reich, K., 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, <<JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY>>, 2022; 87 (4): 815-824. [doi:10.1016/j.jaad.2022.07.019] [https://hdl.handle.net/10807/229028]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/229028
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