LEO Pharma Unveils Tralokinumab Data for Severe Atopic Dermatitis at EADV 2024

A recent study has revealed significant improvements in patients with head and neck atopic dermatitis (AD) who were treated with Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm). The interim data was presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, highlighting findings from the TRACE study, an extensive scientific examination by LEO Pharma A/S.

Adtralza/Adbry has shown to reduce the severity of moderate-to-severe AD in the head and neck region. The TRACE study is an international, prospective, single-cohort study of adult patients with AD, and its interim analysis included data from 824 patients at baseline, 668 at three months, 331 at six months, and 143 at nine months. Notably, 79.5% of these patients had AD involvement in the face, scalp, or neck regions at the beginning of the study.

The results showed a marked improvement over time. For patients with head and neck AD at baseline, the percentage reporting AD in these areas decreased from 79.5% at the start to 67.2% at three months and 52.1% at nine months. This reduction was similar in both dupilumab-naïve and dupilumab-experienced patients. Furthermore, the percentage of patients achieving an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) increased significantly from 1.4% at baseline to 57.4% after nine months.

Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, remarked on the difficulties of treating AD in the head and neck region and expressed optimism about the positive outcomes seen with Adtralza/Adbry. Alexander Egeberg, Head of Global Medical Affairs at LEO Pharma, emphasized that these results underscore the company's dedication to providing advanced treatment options for diverse patient needs.

In addition to the late-breaking data, the TRACE study also included posters that highlighted improvements in patient-reported symptoms such as itch and physician-assessed outcomes like the Eczema Area and Severity Index (EASI). Patients reported a decrease in itch severity, with the mean Peak Pruritus Numeric Rating Scale (PP-NRS) score dropping from 6.3 at baseline to 3.3 after nine months. The mean EASI score also improved from 20.1 at baseline to 3.6 after nine months.

Separate data from the ECZTEND trial, which is an open-label extension study in AD patients aged 65 and over, was also presented. This study showed consistent reporting of adverse events over 4.5 years, and long-term efficacy data demonstrated sustained improvements in AD symptoms.

The TRACE study aims to follow patients for one year, and at the time of the interim analysis, included 824 at baseline, 668 at three months, 331 at six months, and 143 at nine months. Patients were enrolled between November 2021 and July 2023.

Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) is a monoclonal antibody developed to inhibit the interleukin (IL)-13 cytokine involved in the immune and inflammatory processes of AD. It has been approved for treating moderate to severe AD in various regions, including the European Union and the United States.

LEO Pharma, a global leader in medical dermatology since 1908, continues to make significant strides in dermatology research and treatment, serving millions of patients worldwide. The company's dedication to advancing the standard of care is evident in its extensive scientific programs and ongoing commitment to addressing the diverse needs of patients with skin conditions.