Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition

Authors

Eric L. Simpson, Department of Dermatology, Oregon Health and Science University, Portland, Oregon, USA.
Emma Guttman-Yassky, Department of Dermatology and the Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Lawrence F. Eichenfield, Departments of Dermatology and Pediatrics, University of California San Diego and Rady Children's Hospital San Diego, San Diego, California, USA.
Mark Boguniewicz, Division of Allergy-Immunology, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver, Colorado, USA.
Thomas Bieber, Department of Dermatology and Allergy, Christine Kühne-Center for Allergy Research and Education (CK-CARE), University Hospital Bonn, Bonn, Germany.
Shannon Schneider, LEO Pharma, Madison, New Jersey, USA.
Adriana Guana, LEO Pharma, Madison, New Jersey, USA.
Jonathan I. Silverberg, Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA.

Document Type

Journal Article

Publication Date

7-16-2023

Journal

Allergy

DOI

10.1111/all.15811

Keywords

atopic dermatitis; interleukin-13; tralokinumab

Abstract

Atopic dermatitis (AD) is a chronic, inflammatory, intensely pruritic skin disorder associated with significant patient burden. Interleukin (IL)-13 is a cytokine that acts as a driver of immune dysregulation, skin-barrier dysfunction, and microbiome dysbiosis that characterizes AD, and is consistently overexpressed in AD skin. Tralokinumab is a fully human immunoglobulin (Ig) G4 monoclonal antibody that binds specifically to IL-13 with high affinity, thereby inhibiting subsequent downstream IL-13 signaling. Three pivotal phase 3 clinical trials demonstrated that tralokinumab 300 mg every other week, as monotherapy or in combination with topical corticosteroids as needed, provides significant improvements in signs and symptoms of moderate-to-severe AD, as measured by Investigator's Global Assessment 0/1 (clear/almost clear) and Eczema Area and Severity Index-75 at Week 16. Improvements were observed soon after tralokinumab initiation and were maintained over 52 weeks of therapy. Tralokinumab significantly improved patient-reported outcomes such as itch and sleep, and demonstrated a safety profile comparable with placebo; conjunctivitis during tralokinumab therapy was generally mild. Similar results were observed in a phase 3 adolescent trial. The role of IL-13 in the pathophysiology of AD justifies a targeted approach and a wealth of clinical data supports tralokinumab as a new therapeutic option for people with moderate-to-severe AD.

APA Citation

Simpson, Eric L.; Guttman-Yassky, Emma; Eichenfield, Lawrence F.; Boguniewicz, Mark; Bieber, Thomas; Schneider, Shannon; Guana, Adriana; and Silverberg, Jonathan I., "Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition" (2023). GW Authored Works. Paper 3068.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/3068

Department

Dermatology