• 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, and Theodore A Omachi.
• Department of Dermatology, School of Medicine, Oregon Health & Science University, Portland, Oregon.
• J. Am. Acad. Dermatol. 2018 May 1; 78 (5): 863-871.e11.

BackgroundInterleukin (IL)-13 plays a key role in type 2 inflammation and is an emerging pathogenic mediator in atopic dermatitis (AD).ObjectiveWe investigated the efficacy and safety of lebrikizumab, an IL-13 monoclonal antibody, as an add-on to topical corticosteroid (TCS) treatment.MethodsA 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.ResultsIn 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.LimitationsProtocol-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.ConclusionWhen 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.Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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