New Tralokinumab Data Focus On High-Burden Atopic Dermatitis

LEO Pharma presented new analyses of tralokinumab (Adtralza; Adbry [tralokinumab-ldrm]) in adults and adolescents with atopic dermatitis (AD) at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, including real-world findings from TRACE, phase 3 results from ADHAND, and longer-term adolescent outcomes from ECZTRA 6 and its ECZTEND extension.

Tralokinumab Data for High-Burden Atopic Dermatitis Areas

TRACE was a prospective, noninterventional study evaluating tralokinumab treatment for up to 12 months. A subgroup analysis included 742 patients with AD involving 1, 2, or 3 high-burden areas—the head and neck, hands and feet, or genitals—at baseline.

Among 91 patients with all 3 areas affected initially, 48 remained and were assessed at Month 12. Of these patients, 79.2% had fewer affected areas and 25.0% no longer reported involvement in any of the 3 areas. Among patients with 2 affected areas who were assessed at Month 12, 71.0% reported reduced involvement. 76.9% of patients with a baseline Dermatology Life Quality Index score of at least 4 achieved a reduction of at least 4 points.

 “The areas that matter most to patients can often be the hardest to treat – high burden areas such as the face and neck, the hands, or the genitals," said Professor Diamant Thaçi, Director of the Institute and Comprehensive Center for Inflammation Medi-cine, University of Lübeck, Germany, and study co-author, in a press release. "In TRACE, patients with AD affecting more of these areas started with more severe disease and a larger impact on quality of life and sleep than those without high burden involvement. Improvements were seen from three months of treatment with tralokinumab, and the majority reported fewer areas affected after a year."

Other Studies

Separate analyses from the phase 3 ADHAND trial evaluated adults with AD and moderate-to-severe hand involvement. At Week 16, 76.6% of patients receiving tralokinumab monotherapy achieved at least a 4-point DLQI reduction versus 44.7% receiving placebo (P < 0.001). A post hoc analysis found that 59.7% vs 22.8%, respectively, achieved at least a 1.3-point reduction in Hand Eczema Impact Scale score (P < 0.001).

Longer-term data came from a post hoc analysis of 88 adolescents aged 12 to 17 years treated across ECZTRA 6 and ECZTEND for up to approximately 3 years. Response rates remained stable through most of the extension period, according to LEO Pharma, and no new safety concerns were identified.

The findings include subgroup, exploratory, and post hoc analyses, which should be considered when interpreting the results.

Source

LEO Pharma press release. September 30, 2026.