Treatment of Atopic Dermatitis with Tralokinumab, an Anti–IL-13 Monoclonal Antibody

Publication date: Available online 12 June 2018
Source:Journal of Allergy and Clinical Immunology
Author(s): Andreas Wollenberg, Michael D. Howell, Emma Guttman-Yassky, Jonathan I. Silverberg, Christopher Kell, Koustubh Ranade, Rachel Moate, René van der Merwe
BackgroundInterleukin (IL)-13 has an important role in atopic dermatitis (AD) pathogenesis. Tralokinumab is a fully human monoclonal antibody that potently and specifically neutralizes IL-13.ObjectiveTo evaluate the efficacy and safety of tralokinumab in adults with moderate to severe AD.MethodsIn this phase 2b study (NCT02347176), 204 adults were randomized 1:1:1:1 to receive subcutaneous tralokinumab 45 mg, 150 mg, or 300 mg, or placebo, every 2 weeks for 12 weeks, with concomitant topical glucocorticoids. Co-primary endpoints were change from baseline in Eczema Area Severity Index (EASI) and percentage of participants with an Investigator's Global Assessment (IGA) response (0/1 score and reduction of two grades or more from baseline) at week 12.ResultsAt week 12, tralokinumab 300 mg significantly improved change from baseline in EASI versus placebo (adjusted mean difference [95% confidence interval]: −4.9 [–8.76 to –1.13]; P = 0.01), and a greater percentage of participants achieved an IGA response: 26.7% versus 11.8%. Greater responses were found in participants with higher concentrations of biomarkers of increased IL-13 activity. Tralokinumab 300 mg-treated participants demonstrated improvements in Scoring of Atopic Dermatitis, Dermatology Life Quality Index, and pruritus numeric rating scale (7-day mean score) versus placebo. Upper respiratory tract infection was the most frequent treatment-emergent adverse event reported as related to study drug in the placebo (3.9%) and pooled tralokinumab groups (3.9%).ConclusionsTralokinumab treatment was associated with early and sustained improvements in AD symptoms, and an acceptable safety and tolerability profile, thereby providing evidence for targeting IL-13 in AD.

Teaser

Our data provide evidence for targeting IL-13 alone in atopic dermatitis. Tralokinumab demonstrated meaningful improvements in Eczema Area and Severity Index and Investigator's Global Assessment responses, with additional benefits in participants with increased IL-13 activity.


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