Tralokinumab Data for H&N AD Presented at EADV

Nine-month interim data from the TRACE study, showing that tralokinumab/tralokinumab-ldrm reduced the severity of moderate-to-severe atopic dermatitis (AD) in the head and neck region of the body (H&N), were shared through one of LEO Pharma’s five late-breaking oral presentations at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the company announced.

TRACE is an international, prospective, single-cohort study of adult patients with AD who were prescribed Adtralza® (tralokinumab)/Adbry® (tralokinumab-ldrm). At the data cut-off for this interim analysis, the following number of patients were included in the full analysis set (FAS): baseline (n=824), 3 months (n=668), 6 months (n=331), and 9 months (n=143). The late-breaker analysis included patients who had AD involvement on the face, scalp, and/or neck (head and neck area) at baseline (79.5%, 655/824).

In patients with H&N AD at baseline, the percentage still reporting AD in the H&N area decreased to 67.2% (363/540) at 3 months and 52.1% (62/119) at 9 months. Similar decreases were seen in dupilumab-naïve (50%, 42/84) and dupilumab-experienced (57.1%, 20/35) patients at 9 months.

Among patients with baseline H&N AD, the percentage with an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1) increased from 1.4% (9/650) at baseline to 33.6% (172/512) at 3 months, 48.4% (121/250) at 6 months, and 57.4% (58/101) at 9 months of treatment with Adtralza.1

“Atopic dermatitis often affects multiple regions of the body but can be exceptionally burdensome and difficult to treat in the head and neck,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “We are particularly encouraged to see treatment with Adtralza / Adbry leading to such positive real-world outcomes in a challenging region of the body, regardless of previous biologic treatment.”