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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)

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Eric L. Simpson, Carsten Flohr, Lawrence F. Eichenfield, Thomas Bieber, Howard Sofen, Alain Taïeb, Ryan Owen, Wendy Putnam, Marcela Castro, Kendra DeBusk, Chin-Yu Lin, Athina Voulgari, Karl Yen, Theodore A. Omachi

Original languageEnglish
Pages (from-to)863-871.e11
JournalJournal of the American Academy of Dermatology
Early online date17 Jan 2018
DOIs
Accepted/In press9 Jan 2018
E-pub ahead of print17 Jan 2018
PublishedMay 2018

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Abstract

Background Interleukin (IL)-13 plays a key role in type 2 inflammation and is an emerging pathogenic mediator in atopic dermatitis. Objective We investigated the efficacy and safety of lebrikizumab, an anti-IL-13 monoclonal antibody, as add-on to topical corticosteroid (TCS). Methods A randomized, placebo-controlled, double-blind, phase II study. Adults with moderate-to-severe AD were required to use twice-daily TCS, and randomized (1:1:1:1) to lebrikizumab 125 mg single dose (SD), 250 mg SD, 125 mg once every 4 weeks (Q4W), or placebo Q4W for 12 weeks, after 2-week TCS run-in. Primary endpoint was percentage of patients achieving Eczema Area and Severity Index (EASI)-50 at Week 12. Results 209 patients received study drug. At Week 12, significantly more patients achieved EASI-50 with lebrikizumab 125 mg Q4W (82.4%; p=0.026) versus placebo (62.3%); patients receiving lebrikizumab SD showed no statistically significant improvements in EASI-50 versus placebo. Adverse events were similar between groups (66.7% all lebrikizumab vs 66.0% placebo), mostly mild or moderate. Limitations Protocol-mandated twice-daily TCS limits understanding of lebrikizumab efficacy as monotherapy. Short study duration did not allow long-term efficacy or safety evaluation. Conclusions Lebrikizumab 125 mg Q4W led to significant improvement in patients with moderate-to-severe AD, when added to TCS, and was well tolerated.

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