Real-World Data on Tralokinumab Demonstrates Effective Relief for Patients With Atopic Dermatitis Affecting the Genitals

Image Credit: © Te Whatu Ora Health New Zealand; DermNet

A poster¹ from the 2024 Elevate-Derm West Conference reported the safety and efficacy of tralokinumab (Adbry; LEO Pharma) in patients with atopic dermatitis (AD) affecting the genitals. Results stemmed from the TRACE, or Tralokinumab ReAl world Clinical usE, study.²

TRACE is a global, non-interventional, observational study that includes adult patients diagnosed with AD who had been prescribed tralokinumab, a high-affinity monoclonal antibody targeting interleukin-13, according to standard clinical practice. The study enrolled patients from 11 countries across Europe, North America, and the Middle East.

Poster authors Serra-Baldrich et al delved into the interim results of the TRACE study, focusing on improvements in physician-assessed disease severity and patient-reported outcomes after 3 months of treatment with tralokinumab.

The study included 824 participants, with 14.9% (123 patients) identified as having AD on the genitals. Baseline demographics and disease characteristics were similar between patients with genital AD and those without, although patients with genital involvement tended to have higher baseline disease severity. Data collection for the study was completed on October 15, 2023, with a cut-off date for interim analysis on May 24, 2023.

Study endpoints focused on improvements in the Investigator Global Assessment (IGA), Dermatology Life Quality Index (DLQI), and sleep-related symptoms, as well as other patient-reported outcomes.

After 3 months of treatment with tralokinumab, interim results revealed significant improvements in disease severity and quality of life for adult patients with AD on the genital area.

At baseline, all patients with genital AD had IGA scores of 2 or higher, indicating mild to severe disease activity. After 3months of tralokinumab treatment, 67% of patients achieved “clear” or “almost clear” skin (IGA 0/1), a substantial improvement from baseline. Specifically, the proportion of patients reaching IGA 0 (completely clear skin) increased from 0% at baseline to 8% at 3 months.

Those achieving IGA 1 (almost clear skin) rose from 0% at baseline to 59% at 3 months. By contrast, the proportion of patients with moderate disease (IGA 2) decreased from 25% at baseline to 31% at 3 months, demonstrating that even those who did not achieve clear or almost clear skin still experienced a reduction in severity.

Improvements were also evident in QoL indicators, particularly in the DLQI and sleep-related outcomes. On average, patients’ DLQI score showed a reduction from a baseline score of 10.2 to 6.2 after 3 months.

In addition to general QoL improvements, patients reported fewer sleep disruptions. The average baseline Sleep-Numeric Rating Scale score of 5.4 (on a scale of 0 to 10) decreased to 3.1 at 3 months.

The study also assessed patient satisfaction with tralokinumab treatment, noting high adherence and positive perceptions. This suggests that tralokinumab was well-tolerated and that patients felt it was an effective option for managing their AD symptoms.

This interim analysis from the TRACE study highlights that tralokinumab is a viable treatment option for managing genital AD in real-world settings. The drug’s success in achieving “clear” or “almost clear” skin for 2/3 patients at 3 months also highlights the need for thorough assessment of sensitive body regions.

“An increased awareness of involvement of AD on the genitals and treatment options for this neglected area is essential,” according to Serra-Baldrich et al.

References

1. Serra-Baldrich E, Armstrong AW, Fustini T, Iversen U, Vilttrup I, Wiseman M. Real-world effectiveness of tralokinumab in adults with atopic dermatitis on the genitals: Interim data on improvements in physician-assessed disease severity and patient-reported outcomes in up to 3 months of treatment in the TRACE study. Poster presented at: Elevate-Derm West Conference; November 7-10, 2024; Scottsdale, Arizona.
2. Armstrong AW, Rubin C, Jarell A, et al. Tralokinumab real-world use in adults with atopic dermatitis: baseline characteristics of the first 100 patients recruited to the TRACE study in the United States. Br J Dermatol. February 2024. https://doi.org/10.1093/bjd/ljad498.056

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