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

Abstract

Introduction: Atopic dermatitis (AD) can involve any part of the skin, including the genital region. Presentation of AD on genitals is often overlooked/underreported due to reluctance to discuss this sensitive area with clinicians and lack of routine examination of this region. To successfully treat all body regions with AD, increased awareness of AD involvement in underreported sites is needed. Tralokinumab, a monoclonal antibody that specifically targets interleukin-13, is indicated for treatment of moderate-to-severe AD. Phase 3 trials have shown tralokinumab is effective and well-tolerated, and recent case series demonstrated successful use of dupilumab and tralokinumab for AD on the genitals. Here, we evaluated changes in disease severity and patient-reported outcomes (PROs) in patients with AD on the genitals in an interim analysis (IA) of the TRACE study.

Methods: TRACE is a prospective, non-interventional, international, single-cohort study of adults with AD prescribed tralokinumab according to national approved labels. Patients were enrolled between November 2021 and July 2023, with IA data cut-off of October 15th, 2023. Only patients with AD on the genitals were included. Outcome measures collected included: IGA, DLQI, and sleep numerical rating scale (NRS), as per individual clinical practice.

Results: At baseline, 14.9% of patients in the full analysis set (FAS) had AD on the genitals (n=123/824); these patients had a mean age of 42.2 years, mean AD duration of 19.2 years, and the majority were male (63.4%) and White (81.3%). Baseline characteristics were similar to FAS, though a greater proportion of patients with AD on the genitals were male (52.2% in FAS), White (75.7% in FAS), and in Europe. Among patients with AD on genitals at baseline, 25% of patients reported AD on genitals at 3 months (n=100). Proportion of patients with IGA 0/1 increased from 0.0% at baseline (n=122) to 31.9% at 3 months (n=94). Proportion of patients with IGA 4 decreased from 49.2% at baseline (n=122) to 7.4% at 3 months (n=94). Among patients with IGA ≥2 at baseline, 48.9% achieved IGA ≥2-point improvement at 3 months (n=90). Among patients with DLQI ≥6 at baseline, DLQI ≥6-point improvement was achieved in 63.6% of patients at 3 months (n=22). Mean sleep NRS decreased from 6.2 at baseline (n=50) to 3.5 at 3 months (n=26). Overall, improvements in physician-assessed outcomes and PROs were similar in patients with AD on the genitals compared to FAS.

Conclusion: Increasing awareness of the impact of AD on the genitals and available treatment options for this neglected area is crucial. IA results (up to 3 months) of TRACE show effectiveness and improvements in PROs with tralokinumab in adults with AD on genitals in a real-world setting.