Tralokinumab Shows Promising Efficacy in Head and Neck Atopic Dermatitis

Tralokinumab, a monoclonal antibody targeting interleukin-13, has demonstrated significant efficacy in treating moderate-to-severe atopic dermatitis (AD) localized to the head and neck after nine months of therapy, according to findings presented at the Dermatology Education Foundation's DERM 2025 NP/PA CME Conference held in Las Vegas, Nevada. The interim analysis of the TRACE study, led by Dr. April W. Armstrong, Professor and Chief of Dermatology at UCLA and Chair Emeritus of the Medical Board of the National Psoriasis Foundation, revealed that tralokinumab effectively reduced disease severity and improved patients' quality of life.

The TRACE study is a multinational, prospective, single-arm observational trial that enrolled patients from November 2021 to July 2023. Of the 824 participants analyzed, approximately 72% had head and neck involvement, a region notably affected by the distressing symptoms of atopic dermatitis. This condition significantly impacts mental health, leading to feelings of embarrassment and societal stigma, as highlighted by Dr. Armstrong.

The findings indicated that after three months of tralokinumab therapy, the proportion of patients reporting significant head and neck involvement decreased from 79.9% at baseline to 67.2%. This figure further declined to 52.1% by the nine-month mark, showcasing the drug's sustained efficacy. Notably, these improvements were consistent across both dupilumab-naïve and dupilumab-experienced patients, despite the former group's higher baseline severity.

Clinical assessments were conducted using various metrics, including the Peak Pruritus Numeric Rating Scale (PP-NRS), Investigator’s Global Assessment (IGA), and the Dermatology Life Quality Index (DLQI). At baseline, 37.7% of patients exhibited an IGA score of 4, indicating the most severe disease state. By month nine, this figure had dramatically dropped to 2.0%. Simultaneously, the proportion of patients achieving IGA scores of 0 or 1 rose from a mere 1.4% at baseline to 57.4% at nine months, illustrating substantial clinical improvement.

Furthermore, the study underscored improvements in itch severity, with mean PP-NRS scores decreasing from 6.4 at baseline to 3.3 at month nine. Sleep quality also improved significantly, with scores dropping from 5.2 to 2.3 over the same period. Dr. Armstrong concluded that the results emphasize tralokinumab’s potential as an effective therapeutic option for individuals suffering from head and neck atopic dermatitis, providing hope for improved management of this chronic condition.

The TRACE study's findings are particularly relevant as the prevalence of atopic dermatitis continues to rise globally, with the World Health Organization noting that approximately 20% of children and 3% of adults are affected by this condition (WHO, 2022). Given the increasing recognition of the psychological and social burdens associated with skin diseases, the implications of such effective treatments cannot be overstated. As more data emerge from ongoing studies, tralokinumab may reshape the therapeutic landscape for atopic dermatitis, particularly for challenging cases localized to the head and neck region.