Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: Results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial
British Journal of Dermatology Oct 07, 2020
Silverberg JI, Toth D, Bieber T, et al. - Whether tralokinumab (a fully human monoclonal antibody) in combination with TCS has efficacy and safety in the treatment of patients with moderate‐to‐severe atopic dermatitis (AD) who were candidates for systemic therapy, was determined in this double‐blind, placebo plus optional TCS‐controlled phase III trial. Using randomization 2 : 1, patients were assigned to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Re-randomization 1 : 1 to tralokinumab Q2W or Q4W, with TCS as needed, for another 16 weeks, was performed among those who attained an Investigator’s Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab. More tralokinumab‐treated patients vs placebo were shown, at week 16, to achieve IGA 0/1: 38·9% vs 26·2% and EASI 75: 56·0% vs 35·7%. Overall, findings demonstrated the effectiveness as well as the good tolerability of tralokinumab 300 mg plus TCS as needed for the treatment of patients with moderate‐to‐severe AD.
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