Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials

Authors

Andrew Blauvelt, Oregon Medical Research Center, Portland, OR, USA.
Jacob P. Thyssen, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Emma Guttman-Yassky, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Thomas Bieber, University Hospital Bonn, Bonn, Germany.
Esther Serra-Baldrich, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Eric Simpson, Oregon Health & Science University, Portland, OR, USA.
David Rosmarin, Indiana University School of Medicine, Indianapolis, IN, USA.
Hany Elmaraghy, Eli Lilly and Company, Indianapolis, IN, USA.
Eric Meskimen, Eli Lilly and Company, Indianapolis, IN, USA.
Chitra R. Natalie, Eli Lilly and Company, Indianapolis, IN, USA.
Zhuqing Liu, Eli Lilly and Company, Indianapolis, IN, USA.
Chenjia Xu, Eli Lilly and Company, Indianapolis, IN, USA.
Evangeline Pierce, Eli Lilly and Company, Indianapolis, IN, USA.
MaryAnn Morgan-Cox, Eli Lilly and Company, Indianapolis, IN, USA.
Esther Garcia Gil, Almirall S.A., Barcelona, Spain.
Jonathan I. Silverberg, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.

Document Type

Journal Article

Publication Date

3-30-2023

Journal

The British journal of dermatology

DOI

10.1093/bjd/ljad022

Abstract

BACKGROUND: Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to interleukin (IL)-13. OBJECTIVES: To evaluate the efficacy and safety of lebrikizumab monotherapy in adolescent and adult patients with moderate-to-severe atopic dermatitis (AD) over 52 weeks of treatment in ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). METHODS: Patients who responded to lebrikizumab 250 mg every 2 weeks (Q2W) at the end of the 16-week induction period were re-randomized 2 : 2 : 1 to receive lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W) or placebo Q2W (lebrikizumab withdrawal) for 36 additional weeks. Response at week 16 was defined as achieving a 75% reduction in Eczema Area Severity Index (EASI 75) or an Investigator's Global Assessment (IGA) of 0 or 1, with a ≥ 2-point improvement and no rescue medication use. Multiple imputation was used to handle missing data. Intermittent use of topical therapy was permitted during the maintenance period. RESULTS: After 52 weeks, an IGA of 0 or 1 with a ≥ 2 point improvement was maintained by 71.2% of patients treated with lebrikizumab Q2W, 76.9% of patients treated with lebrikizumab Q4W and 47.9% of patients in the lebrikizumab withdrawal arm. EASI 75 was maintained by 78.4% of patients treated with lebrikizumab Q2W, 81.7% of patients treated with lebrikizumab Q4W and 66.4% of patients in the lebrikizumab withdrawal arm at week 52. Across treatment arms, proportions of patients using any rescue therapy were 14.0% (ADvocate1) and 16.4% (ADvocate2). During the combined induction and maintenance periods of ADvocate1 and ADvocate2, 63.0% of lebrikizumab-treated patients reported any treatment emergent adverse event, with most events (93.1%) being mild or moderate in severity. CONCLUSIONS: After a 16-week induction period with lebrikizumab Q2W, lebrikizumab Q2W and Q4W maintained similar improvement of the signs and symptoms of moderate-to-severe AD, with a safety profile consistent with previously published data.

APA Citation

Blauvelt, Andrew; Thyssen, Jacob P.; Guttman-Yassky, Emma; Bieber, Thomas; Serra-Baldrich, Esther; Simpson, Eric; Rosmarin, David; Elmaraghy, Hany; Meskimen, Eric; Natalie, Chitra R.; Liu, Zhuqing; Xu, Chenjia; Pierce, Evangeline; Morgan-Cox, MaryAnn; Garcia Gil, Esther; and Silverberg, Jonathan I., "Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials" (2023). GW Authored Works. Paper 2525.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/2525

Department

Dermatology