Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2)

Summary Background Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin‐13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in...

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Published in:British journal of dermatology (1951) 2021-03, Vol.184 (3), p.437-449
Main Authors: Wollenberg, A., Blauvelt, A., Guttman‐Yassky, E., Worm, M., Lynde, C., Lacour, J.‐P., Spelman, L., Katoh, N., Saeki, H., Poulin, Y., Lesiak, A., Kircik, L., Cho, S.H., Herranz, P., Cork, M.J., Peris, K., Steffensen, L.A., Bang, B., Kuznetsova, A., Jensen, T.N., Østerdal, M.L., Simpson, E.L.
Format: Article
Language:English
Subjects:
Adverse events
Atopic dermatitis
Clinical Trial
Clinical trials
Corticosteroids
Dermatitis
Double-blind studies
Eczema
Immunoglobulin A
Inflammation
Monoclonal antibodies
Original
Placebos
Pruritus
Quality of life
Sleep
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Summary:Summary Background Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin‐13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. Objectives To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate‐to‐severe AD who had an inadequate response to topical treatments. Methods In two 52‐week, randomized, double‐blind, placebo‐controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate‐to‐severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885. Results At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1–13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8–16·4; P 
ISSN:0007-0963
1365-2133
DOI:10.1111/bjd.19574