Research ExplorerPublicationsLong-term 2-year safety and efficacy of tralokinumab in adul...

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

Standard

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, Vol. 87, No. 4, 10.2022, p. 815-824.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Blauvelt, A, Langley, RG, Lacour, J-P, Toth, D, Laquer, V, Beissert, S, Wollenberg, A, Herranz, P, Pink, AE, Peris, K, Fangel, S, Gjerum, L, Corriveau, J, Saeki, H, Warren, RB, Simpson, E & Reich, K 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', J AM ACAD DERMATOL, vol. 87, no. 4, pp. 815-824. https://doi.org/10.1016/j.jaad.2022.07.019

APA

Blauvelt, A., Langley, R. G., Lacour, J-P., 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. (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. J AM ACAD DERMATOL, 87(4), 815-824. https://doi.org/10.1016/j.jaad.2022.07.019

Vancouver

Blauvelt A, Langley RG, Lacour J-P, Toth D, Laquer V, Beissert S et al. 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. J AM ACAD DERMATOL. 2022 Oct;87(4):815-824. https://doi.org/10.1016/j.jaad.2022.07.019

Bibtex

@article{b1f34ce2a61a4f7894b5721fe27f1369,
title = "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",
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.",
keywords = "Adult, Antibodies, Monoclonal/adverse effects, Dermatitis, Atopic/drug therapy, Double-Blind Method, Glucocorticoids/therapeutic use, Humans, Severity of Illness Index, Treatment Outcome",
author = "Andrew Blauvelt and Langley, {Richard G} and Jean-Philippe Lacour and Darryl Toth and Vivian Laquer and Stefan Beissert and Andreas Wollenberg and Pedro Herranz and Pink, {Andrew E} and Ketty Peris and Stine Fangel and Le Gjerum and Joshua Corriveau and Hidehisa Saeki and Warren, {Richard B} and Eric Simpson and Kristian Reich",
note = "Copyright {\textcopyright} 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.",
year = "2022",
month = oct,
doi = "10.1016/j.jaad.2022.07.019",
language = "English",
volume = "87",
pages = "815--824",
journal = "J AM ACAD DERMATOL",
issn = "0190-9622",
publisher = "Mosby Inc.",
number = "4",

}

RIS

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 -