Safety and efficacy of eblasakimab, an interleukin 13 receptor α1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: A phase 1b, multiple-ascending dose study

Authors

Karen A. Veverka, ASLAN Pharmaceuticals, San Mateo, California and Singapore.
Steven T. Thng, Skin Research Institute of Singapore, Agency for Science, Technology and Research, National Skin Center, Singapore.
Jonathan I. Silverberg, Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.
April W. Armstrong, Division of Dermatology, University of California, Los Angeles, Los Angeles, California.
Josemund Menezes, ASLAN Pharmaceuticals, San Mateo, California and Singapore.
Alexandre Kaoukhov, ASLAN Pharmaceuticals, San Mateo, California and Singapore.
Andrew Blauvelt, Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.

Document Type

Journal Article

Publication Date

10-20-2023

Journal

Journal of the American Academy of Dermatology

DOI

10.1016/j.jaad.2023.10.026

Keywords

EASI; IL-13; IL-4; atopic dermatitis; eblasakimab; moderate-to-severe AD; pruritus; type 2 inflammation

Abstract

BACKGROUND: Eblasakimab, an interleukin (IL)-13 receptor α1 antagonist, blocks IL-4 and IL-13 signaling through the type 2 receptor. OBJECTIVE: The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD). METHODS: In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes included percentage change in the Eczema Area and Severity Index from baseline; Eczema Area and Severity Index improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline. RESULTS: Treatment-emergent adverse events were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in Eczema Area and Severity Index versus placebo (-65% vs -27%, P = .014). Other key secondary physician- and patient-reported end points were met. LIMITATIONS: Longer studies are required to confirm eblasakimab safety and efficacy in AD patients. CONCLUSIONS: Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.

APA Citation

Veverka, Karen A.; Thng, Steven T.; Silverberg, Jonathan I.; Armstrong, April W.; Menezes, Josemund; Kaoukhov, Alexandre; and Blauvelt, Andrew, "Safety and efficacy of eblasakimab, an interleukin 13 receptor α1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: A phase 1b, multiple-ascending dose study" (2023). GW Authored Works. Paper 3569.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/3569

Department

Dermatology