D2.494 - Tralokinumab treatment in adults with atopic dermatitis who were previously treated with dupilumab: 12-months real-world data from the TRACE study

Tralokinumab, a monoclonal antibody targeting interleukin-13, is approved for moderate-to-severe atopic dermatitis (AD) and has demonstrated good efficacy and tolerability in Phase 3 trials. This study evaluates effectiveness with up to 12-months tralokinumab treatment in AD patients previously treated with dupilumab in a real-world setting.

TRACE is a prospective, non-interventional, international, single-cohort study of adults with AD prescribed tralokinumab per national labels at treating physician’s discretion. Evaluations included IGA, EASI, and SCORAD. Data are presented as observed.

824 patients were enrolled and comprised the full analysis set (FAS). Of these, 182 (22.1%) had previously been treated with dupilumab. Dupilumab-experienced patients had slightly less severe AD at baseline, but overall effectiveness of 12 months of tralokinumab treatment was comparable between dupilumab-experienced patients and the FAS. The proportion achieving a composite response of IGA 0/1, EASI≤7, or SCORAD<10 increased from 21.1% (n=180) at baseline to 80.9% (n=68) at 12 months among dupilumab-experience patients, compared to 13.2% (n=818) and 85.8% (n=415) in the FAS.

Among dupilumab-experience patients, the proportion with IGA 0/1 (clear/almost-clear skin) increased from 6.1% (n=165) at baseline to 53.8% (n=65) at 12 months, and 2.1% (n=780) to 66.2% (n=397) in the FAS. Mean EASI score decreased from 16.9 (n=127) at baseline to 4.8 (n=51) at 12 months in dupilumab-experienced patients and 20.1 (n=640) to 2.9 (n=354) in the FAS. The proportion of patients with EASI ≤7 (no or mild disease) increased from 26.0% (n=127) at baseline to 84.3% (n=51) at 12 months in dupilumab-experienced patients and 13.8% (n=640) to 89.0% (n=354) in the FAS.

Marked improvements in clinician-reported outcomes comparable to the overall TRACE population were achieved during up to 12-months tralokinumab treatment in a real-world setting in difficult-to-treat AD patients previously treated with dupilumab.