Real-world use of tralokinumab in patients with atopic dermatitis involving high-burden areas: Effectiveness and impact on quality of life in the prospective, non-interventional 12-month TRACE study

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition associated with negative impacts on patients’ quality of life (QoL). Managing AD involving high-burden areas, such as the head, neck, hands, feet, or genitals, can be challenging, with a need for long-term, effective treatment. Tralokinumab, an IL-13-targeting monoclonal antibody, was effective and well tolerated in phase 3 trials of adults with AD. To date, TRACE is the largest real-world study of adults with AD treated with tralokinumab. Here, we evaluate the effectiveness of tralokinumab in patients with AD involving high-burden areas, and related improvements in QoL. Methods: In the international, non-interventional TRACE study adults with AD were prescribed tralokinumab and observed for up to 12 months. Patients in this analysis reported AD involvement at baseline of at least one high-burden area, which included the head and neck (H&N; face and/or neck and/or scalp), hands and/or feet (H&F), or genitals. Patients were assigned to one of three subgroups based on whether they had AD involvement of one, two, or three high-burden areas at baseline. Results: Of 824 patients enrolled in TRACE, 742 had AD involving one (n=302), two (n=349), or three (n=91) high-burden areas at baseline; the most common was H&N (n=654), followed by H&F (n=495), and genitals (n=124). One in four patients (24.5%) had previous experience with biologic treatment. Patients with multiple high-burden areas affected at baseline were more likely to have severe AD (mean baseline IGA=4 in 27.2%, 37.2%, and 57.1% of patients with one, two, or three high-burden areas involved, respectively) and experience a greater negative impact on QoL and sleep (mean baseline DLQI; 11.8, 13.6, and 15.8 for patients with one, two, or three high-burden areas involved, respectively; mean Sleep-NRS; 4.7, 5.5, and 5.6 for patients with one, two, or three high-burden areas involved, respectively). At Month 12 of tralokinumab treatment, 71.0% (n=193) of patients with two high-burden areas involved at baseline showed improvement. Of these, 28.0% no longer reported any involvement of the high-burden areas identified at baseline, while 43.0% had reduced involvement to just one of the areas. Among patients with three high-burden areas involved at baseline, 79.2% (n=48) improved with treatment: 25.0% reported no involvement in any of the baseline high-burden areas, while 37.5% and 16.7% reduced involvement to one or two of these areas, respectively. Additionally, 43.3% (n=178) of patients with one high-burden area involved at baseline no longer reported involvement of that area after 12 months of treatment. Among patients with baseline involvement of at least one high-burden area, tralokinumab was effective overall, with mean EASI decreasing from 20.4 at baseline to 2.8 at Month 12, and a ≥4-point reduction in DLQI for 76.9% (n=130) of patients with a baseline DLQI score of at least 4. Conclusion: Among patients with multiple high-burden areas affected at baseline, over 70% demonstrated a reduction in high-burden involvement after 12 months of treatment. These sustained improvements were aligned with clinically meaningful gains in QoL, underscoring the substantial and long-term benefit of tralokinumab in managing difficult-to-treat AD.