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
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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; Reich, Kristian.
in: J AM ACAD DERMATOL, Jahrgang 87, Nr. 4, 10.2022, S. 815-824.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - Blauvelt, Andrew
AU - Langley, Richard G
AU - Lacour, Jean-Philippe
AU - Toth, Darryl
AU - Laquer, Vivian
AU - Beissert, Stefan
AU - Wollenberg, Andreas
AU - Herranz, Pedro
AU - Pink, Andrew E
AU - Peris, Ketty
AU - Fangel, Stine
AU - Gjerum, Le
AU - Corriveau, Joshua
AU - Saeki, Hidehisa
AU - Warren, Richard B
AU - Simpson, Eric
AU - Reich, Kristian
N1 - Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - Adult
KW - Antibodies, Monoclonal/adverse effects
KW - Dermatitis, Atopic/drug therapy
KW - Double-Blind Method
KW - Glucocorticoids/therapeutic use
KW - Humans
KW - Severity of Illness Index
KW - Treatment Outcome
U2 - 10.1016/j.jaad.2022.07.019
DO - 10.1016/j.jaad.2022.07.019
M3 - SCORING: Journal article
C2 - 35863467
VL - 87
SP - 815
EP - 824
JO - J AM ACAD DERMATOL
JF - J AM ACAD DERMATOL
SN - 0190-9622
IS - 4
ER -