Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: Placebo-controlled, randomized, phase III clinical trial (ECZTRA 7)
British Journal of Dermatology Jan 05, 2022
Gutermuth J, Pink AE, Worm M, et al. - Findings demonstrate the effectiveness as well as good tolerability of tralokinumab 300 mg plus topical corticosteroids (TCS) as needed in patients with severe atopic dermatitis (AD) whose disease was not adequately controlled with ciclosporin A (CSA; a commonly used, broad immunosuppressant in AD) or who had contraindications to oral CSA.
European adults with severe AD took part in this 26-week, multicenter, parallel, randomized, double-blind, placebo-controlled, phase III trial, and were randomly assigned (n=277) 1 : 1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks plus TCS as needed.
EASI 75 (a 75% improvement in Eczema Area and Severity Index) was achieved at week 16 in more patients treated with tralokinumab plus TCS vs placebo plus TCS [64·2% vs 50·5%; difference 14·1% (95% confidence interval 2·5–25·7); P = 0·018], which increased further up to week 26.
AD severity improved along with early improvements evident in patient-reported outcomes, including Dermatology Life Quality Index, Patient-Oriented Eczema Measure, pruritus and sleep interference.
A higher EASI75 response at week 16 was seen with tralokinumab plus TCS in patients who had previously failed CSA therapy vs placebo plus TCS (57% vs 41%).
Both treatment arms demonstrated a similar overall incidence of adverse events.
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