Tralokinumab Reduced Severity of Atopic Dermatitis in Head, Neck Regions After 9 Months

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New 9-month interim findings drawn from the TRACE study show that tralokinumab-ldrm (Adbry) reduced patients’ moderate-to-severe atopic dermatitis severity on the head and neck areas of the body specifically.¹

These findings, presented at the European Academy of Dermatology & Venereology (EADV) Congress in Amsterdam, highlighted the results of tralokinumab on a unique subset of patients with atopic dermatitis.The disease is a long-term inflammatory condition known for the presence of eczematous lesions and pruritus, resulting from skin barrier dysfunction and immune system dysregulation.

“Atopic dermatitis often affects multiple regions of the body but can be exceptionally burdensome and difficult to treat in the head and neck,” Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, said in a statement. “We are particularly encouraged to see treatment with (tralokinumab) leading to such positive real-world outcomes in a challenging region of the body, regardless of previous biologic treatment.”¹

Cytokines associated with type 2 immune responses in atopic dermatitis, especially interleukin (IL)-13, play an essential role in its pathophysiology. IL-22 overproduction also contributes to the development of the skin condition.

Tralokinumab, a fully human monoclonal antibody, was formulated to target and block the IL-13 cytokine and thus prevent inflammation by inhibiting interaction with the receptor subunits α1 and α2. It has been approved for moderate to severe atopic dermatitis for those aged 12 and older in the US, Canada, the European Union, the UAE, Great Britain, and South Korea, and approved for adults within Switzerland, Saudi Arabia, and Japan.

To evaluate adults with atopic dermatitis, the TRACE study was conducted as a prospective, non-interventional, international cohort study. Patient numbers by the cutoff for the interim analysis were, in the full analysis set, 824 at baseline, 668 at 3 months, 331 at 6 months, and 143 at 9 months.²

In 2 poster presentations at EADV, the investigators concluded that 9 months of treatment with tralokinumab led to substantial patient-reported itch symptom improvements. Specifially, the team noted that the Peak Pruritus Numeric Rating Scale (PP-NRS) dipped from a mean score of 6.3 at the point of baseline to 3.3 following 9 months.

In a similar vein, the research team reported that scores on the physician-assessed Eczema Area and Severity Index (EASI) saw improvements from a baseline score of 20.1 to 3.6 over the same timeframe.

In this announcement, the ongoing ECZTEND phase 3 trial was also highlighted. It was a 5-year extension trial assessing the long-term safety and efficacy of tralokinumab among patients who had taken part in prior research. Subects were allowed to take part in ECZTEND following their completion of the original trial, regardless of their response to therapy or whether they had received tralokinumab or a placebo.³

The data presented from ECZTEND specifically looked at subjects with atopic dermatitis who were also aged 65 and older. The investigators concluded that the rates of adverse events following up to 4.5 years of tralokinumab therapy remained consistent with earlier findings.

They also highlighted the long-term efficacy data suggesting improvements in disease were sustained as far as symptoms. This was noted as being in line with outcomes noted in the broader trial population.

“With five late-breakers at this conference, we are proud to showcase our extensive scientific program and the significant strides we are making in dermatology,” Alexander Egeberg, head of global medical affairs at LEO Pharma, said in a statement.¹

References

1. ^{LEO Pharma Presents Late-breaking Tralokinumab Data at EADV 2024 for Moderate-to-Severe Atopic Dermatitis (AD) in the Difficult-to-Treat Head and Neck Region. LEO Pharma. September 27, 2024. https://www.businesswire.com/news/home/20240927314414/en/LEO-Pharma-Presents-Late-breaking-Tralokinumab-Data-at-EADV-2024-for-Moderate-to-Severe-Atopic-Dermatitis-AD-in-the-Difficult-to-Treat-Head-and-Neck-Region.}
2. ^{Armstrong A, Ameen A, Bagel J, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Late Breaking News Session. D3T01.3.}
3. ^{Blauvelt A, Merola J, Carrascosa JM, et al. Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. E-poster Presentation. P0479.}