Tralokinumab Effective in Head, Neck Atopic Dermatitis After 9 Months of Treatment

Up to 9 months of tralokinumab therapy reduces head and neck atopic dermatitis severity and improves quality of life in real-world settings, recent interim findings suggest, and all such improvements are similar regardless of prior use of dupilumab.¹

These data were presented as a poster during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas, Nevada. This research was authored by such researchers as April W. Armstrong, MD, MPH, Professor and Chief of Dermatology at UCLA and Chair Emeritus of the Medical Board of the National Psoriasis Foundation.

Armstrong and colleagues’ poster was titled ‘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.’

The investigators highlighted the persistent inflammatory skin condition and its impacts on the head and neck regions of the body. Approximately 72% of those with moderate-to-severe atopic dermatitis are impacted in this area. Additionally, the stigma, mental health distress, feelings of embarrassment, and overall mental health and quality of life reductions are especially known to be connected to this form of the disease.

One approved therapy for moderate-to-severe atopic dermatitis is tralokinumab, a monoclonal antibody designed to target interleukin (IL)-13. Armstrong and coauthors’ interim analysis of the ongoing TRACE study looked at the effects of treating atopic dermatitis with tralokinumab, specifically examining signs and symptoms in patients with head and neck involvement.

Adults patients diagnosed with the skin disease who began tralokinumab treatment per national prescribing guidelines were involved in the TRACE analysis. The study involved a multinational, prospective, single-arm observational trial design and assesses data from patients recruited between November 2021 – July 2023.

Armstrong et al’s current analysis focused on those with scalp, facial, or neck involvement at the point of baseline. Peak Pruritus Numeric Rating Scale (PP-NRS), Investigator’s Global Assessment (IGA), Dermatology Life Quality Index (DLQI), disease location, RECAP (The RECap for AtoPic eczema), and Sleep NRS were all examples of clinical outcomes evaluated by the investigative team.

Overall, the team fund that 79.9% of the 824 patients in the full analysis set presented with head and neck involvement at the beginning of this research. Average patient age was noted by Armstrong and colleagues as 42.1 years, with 53.0% being labeled male, 76.6% as White, and an average disease duration of 20.6 years.

In those with baseline atopic dermatitis involvement of the head and neck, the proportion still reporting such impacts dipped to 67.2% following 3 months of therapy with tralokinumab.¹ It dipped further down to 52.1% by the 9-month mark. At this point, such reductions were observed by the investigators in both dupilumab-naïve individuals (50.0%) and patients previously given dupilumab (57.1%).

In terms of clinical improvements among patients with atopic dermatitis involving the head and neck, it was noted that the proportion of participants showing the most severe disease (IGA score of 4) lowered from 37.7%at the point of baseline to 4.7% by Month 3. It then dipped to 2.8% at Month 6 and 2.0% by Month 9. Among those showing an IGA scores of 2 or higher at baseline, patients who attained at least a 2-point reduction rose from 46.4% at Month 3 to 59.1% at the 6-month mark and 71.6% at 9 months.

The percentage of patients achieving IGA scores of 0 or 1 increased from 1.4% (9 of 650) at baseline to 33.6% (172 of 512) at 3 months, 48.4% (121 of 250) at 6 months, and 57.4% (58 of 101) at 9 months. Over 50.0% of those with a baseline DLQI score of 6 or greater were shown by Armstrong and coauthors to have notably improved by a reduction of at least 6 points. Specifically, they found that 57.9% saw such a reduction at Month 3, 63.6% at Month 6, and 74.4% at Month 9.

Additionally, the investigative team noted that itch severity, as determined by the mean PP-NRS score, improved from 6.4 at baseline to 4.2 at Month 3, 3.5 at Month 6, and 3.3 at Month 9. Sleep quality, as determined by Sleep NRS scores, also improved from a mean of 5.2 at baseline to 2.8 at 3 months and 2.3 at both the 6 and 9-month marks.

“Similar improvements were observed across all endpoints in both dupilumab-naïve (n=154) and dupilumab-experienced (n=501) patients with H&N AD at baseline, despite higher baseline disease severity in dupilumab-naïve patients,” Armstrong et al concluded.¹

For more data presented at DERM 2025, view our latest conference coverage here.

References

1. Armstrong A, Ameen A, Pink A, 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. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 – 26, 2025; Las Vegas, Nevada.