Tralokinumab for Head & Neck Atopic Dermatitis – 9 Month Results
Tralokinumab Shows Notable Improvements in Head and Neck Atopic Dermatitis
New data presented at DERM 2025 highlights the effectiveness of tralokinumab in patients wiht atopic dermatitis (AD) affecting the head and neck, demonstrating substantial clinical improvements and quality of life enhancements.
Key Findings on Head and Neck AD efficacy
Interim data from the TRACE study, presented by Armstrong and colleagues at the DERM 2025 NP/PA CME Conference, reveals promising results for tralokinumab in treating atopic dermatitis, particularly in the challenging head and neck region. The study tracked patients with an average disease duration of 20.6 years, indicating the chronic nature of the condition.
Reduction in Head and Neck Involvement
A significant proportion of patients experiencing head and neck atopic dermatitis at baseline saw a reduction in these symptoms following treatment with tralokinumab.
3 Months: 67.2% of patients still reported head and neck involvement.
9 Months: This figure decreased to 52.1%. Notably, this improvement was consistent across both dupilumab-naïve individuals (50.0%) and those previously treated with dupilumab (57.1%).
Clinical Severity Improvements
The impact of tralokinumab on disease severity, as measured by the Investigator’s Global Assessment (IGA) score, was substantial:
Most Severe Disease (IGA score of 4): The proportion of patients with the most severe disease dropped from 37.7% at baseline to just 4.7% by Month 3, further decreasing to 2.8% at Month 6 and 2.0% by Month 9.
Significant IGA Score Reduction: Among patients with an IGA score of 2 or higher at baseline, those achieving at least a 2-point reduction increased steadily from 46.4% at Month 3 to 59.1% at Month 6, and a remarkable 71.6% by Month 9.
Achieving Clear or Almost Clear Skin (IGA scores of 0 or 1): The percentage of patients reaching these desirable outcomes rose dramatically from 1.4% at baseline to 33.6% at 3 months, 48.4% at 6 months, and 57.4% by 9 months.
Quality of life Enhancements
Beyond clinical scores, tralokinumab also demonstrated a positive impact on patients’ daily lives, particularly concerning itch and sleep.
Itch Severity Reduction
The mean Patient-Reported Outcome for Itch numerical Rating Scale (PP-NRS) score,a measure of itch severity,improved significantly:
Baseline: 6.4
Month 3: 4.2
Month 6: 3.5
Month 9: 3.3
sleep Quality Improvement
Sleep quality, assessed by the Sleep NRS score, also saw marked improvement:
Baseline: 5.2
Month 3: 2.8
Month 6: 2.3
month 9: 2.3
Dermatology Life Quality Index (DLQI)
For patients with a baseline DLQI score of 6 or greater, indicating a significant impact on quality of life, tralokinumab led to substantial improvements.Armstrong and coauthors found that over 50% of these patients experienced a reduction of at least 6 points in their DLQI score:
Month 3: 57.9%
Month 6: 63.6%
Month 9: 74.4%
Consistent Efficacy Across Patient groups
The study’s conclusions emphasized the broad applicability of tralokinumab’s benefits. “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,” the researchers noted. This suggests that tralokinumab is an effective treatment option regardless of prior biologic exposure.
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