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Cited by 331

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Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE)

Open access
Simpson, Eric L., Flohr, Carsten, Eichenfield, Lawrence F., Bieber, Thomas, Sofen, Howard, Taïeb, Alain, Owen, Ryan, Putnam, Wendy, Castro, Marcela, DeBusk, Kendra, Lin, Chin-Yu, Voulgari, Athina, Yen, Karl, Omachi, Theodore A.·2018·Journal of the American Academy of Dermatology

Abstract

BACKGROUND: Interleukin (IL)-13 plays a key role in type 2 inflammation and is an emerging pathogenic mediator in atopic dermatitis (AD). OBJECTIVE: We investigated the efficacy and safety of lebrikizumab, an IL-13 monoclonal antibody, as an add-on to topical corticosteroid (TCS) treatment. METHODS: A randomized, placebo-controlled, double-blind, phase 2 study. Adults with moderate-to-severe AD were required to use TCS twice daily and then randomized (1:1:1:1) to lebrikizumab 125 mg single dose, lebrikizumab 250 mg single dose, lebrikizumab 125 mg every 4 weeks for 12 weeks, or placebo every 4 weeks for 12 weeks, after a 2-week TCS run-in. The primary endpoint was percentage of patients achieving Eczema Area and Severity Index (EASI)-50 at week 12. RESULTS: In total, 209 patients received the study drug. At week 12, significantly more patients achieved EASI-50 with lebrikizumab 125 mg every 4 weeks (82.4%; P = .026) than placebo every 4 weeks (62.3%); patients receiving a single dose of lebrikizumab showed no statistically significant improvements in EASI-50 compared with placebo. Adverse events were similar between groups (66.7% all lebrikizumab vs 66.0% placebo) and mostly mild or moderate. LIMITATIONS: Protocol-mandated twice daily TCS treatment limits our understanding of the efficacy of lebrikizumab as a monotherapy. The short study duration did not enable long-term efficacy or safety evaluations. CONCLUSION: When combined with TCS, lebrikizumab 125 mg taken every 4 weeks led to a significant improvement and was well tolerated in patients with moderate-to-severe AD.

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Metadata

Authors
Simpson, E. L., Flohr, C., Eichenfield, L. F., Bieber, T., Sofen, H., Taïeb, A., Owen, R., Putnam, W., Castro, M., DeBusk, K., Lin, C.-Y., Voulgari, A., Yen, K., & Omachi, T. A.
Venue
Journal of the American Academy of Dermatology
Publisher
Elsevier BV
Published
2018-05
Volume
78
Issue
5
Pages
863-871.e11
ISSN
0190-9622 (ISSN-L)
OpenAlex
W2783829013
Cited by
331
References
29
FWCI
44.80
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). https://app.cochat.ai/papers/10.1016/j.jaad.2018.01.017
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Simpson, E. L., Flohr, C., Eichenfield, L. F., Bieber, T., Sofen, H., Taïeb, A., Owen, R., Putnam, W., Castro, M., DeBusk, K., Lin, C.-Y., Voulgari, A., Yen, K., & Omachi, T. A. (2018). Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2018.01.017

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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