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.

Background Tralokinumab is a fully human monoclonal antibody that specifically neutralizes interleukin-13, a key driver of atopic dermatitis (AD). Objectives To evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who were candidates for systemic therapy. Methods This was a double-blind, placebo plus TCS controlled phase III trial. Patients were randomized 2 : 1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Patients who achieved 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 were rerandomized 1 : 1 to tralokinumab Q2W or every 4 weeks (Q4W), with TCS as needed, for another 16 weeks. Results At week 16, more patients treated with tralokinumab than with placebo achieved IGA 0/1: 38 center dot 9% vs. 26 center dot 2% [difference (95% confidence interval): 12 center dot 4% (2 center dot 9-21 center dot 9); P = 0 center dot 015] and EASI 75: 56 center dot 0% vs. 35 center dot 7% [20 center dot 2% (9 center dot 8-30 center dot 6); P < 0 center dot 001]. Of the patients who were tralokinumab responders at week 16, 89 center dot 6% and 92 center dot 5% of those treated with tralokinumab Q2W and 77 center dot 6% and 90 center dot 8% treated with tralokinumab Q4W maintained an IGA 0/1 and EASI 75 response at week 32, respectively. Among patients who did not achieve IGA 0/1 and EASI 75 with tralokinumab Q2W at 16 weeks, 30 center dot 5% and 55 center dot 8% achieved these endpoints, respectively, at week 32. The overall incidence of adverse events was similar across treatment groups. Conclusions Tralokinumab 300 mg in combination with TCS as needed was effective and well tolerated in patients with moderate-to-severe AD.