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

Abstract

Introduction: AD is a chronic skin disease affecting multiple areas, including the head and neck (H&N) region, reported in 72% of patients with moderate-to-severe AD. H&ND, in particular, is associated with social embarrassment, stigmatization, and negative impact on patients’ QoL and mental health. Tralokinumab, a monoclonal antibody specifically targeting interleukin-13, is indicated for treatment of moderate-to-severe AD. Here, we evaluated the effectiveness of tralokinumab in patients with H&N AD in an interim analysis (IA) of the non-interventional TRACE study.

Methods: TRACE is an international, prospective, single-cohort study of adult patients with AD (enrolled between Nov-2021 and Jul-2023) prescribed tralokinumab according to national approved labels. At IA data cut-off (Oct-15-2023), not all patients had completed all visits. This analysis included patients with AD involvement on face, scalp, and neck at baseline. Outcomes collected included AD localization, and overall AD measures, including IGA, DLQI, RECAP, Peak Pruritus NRS (PP-NRS), and/or Sleep NRS per individual clinical practice. Data presented as-observed.

Results: In patients with H&N AD at baseline (79.5% of full analysis set), the percentages that still reported AD on the H&N area decreased to 67.2% (363/540) at 3 months (M) and to 52.1% at 9M. Percentage with IGA 0/1 increased from 1.4% (9/650) at baseline to 33.6% (172/512) at 3M, 48.4% (121/250) at 6M, and 57.4% (58/101) at 9M of tralokinumab. The percentages of patients with IGA 4 decreased from 37.7% (245/650) at baseline to 4.7% (24/512) at 3M, 2.8% (7/250) at 6M, and 2.0% (2/101) at 9M. Among patients with baseline IGA≥2, the percentages achieving ≥2-point improvement in IGA increased from 46.4% (220/474) at 3M to 59.1% (140/237) at 6M, and 71.6% (68/95) at 9M. Among patients with baseline DLQI ≥6, the majority achieved ≥6-point reduction in DLQI with tralokinumab: 57.9% (84/145) at 3M, 63.6% (49/77) at 6M, and 74.4% (32/43) at 9M. Mean PP-NRS improved from 6.4 (n=387) at baseline to 4.2 (n=213) at 3M, 3.5 (n=111) at 6M, and 3.3 (n=59) at 9M. Mean Sleep NRS improved from 5.2 (n=305) at baseline to 2.8 (n=170) at 3M, and 2.3 at 6M and 9M (n=84 and n=53, respectively) of tralokinumab. Similar improvements were observed across endpoints in both dupilumab-naive (n=154) and dupilumab-experienced (n=501) patients, despite higher baseline disease severity in dupilumab-naive patients.

Conclusion: Up to 9M months of tralokinumab treatment in a real-world setting reduced H&N involvement and improved disease severity and QoL in patients with AD in the difficult to treat H&N area; all improvements were similar regardless of prior dupilumab use.