Real-world Effectiveness of Tralokinumab in Adults with Atopic Dermatitis: Interim Data on Improvements in Patients with Atopic Dermatitis with Hands and Feet Involvement after up to 9 Months of Treatment in the TRACE Study

Abstract

Introduction: AD is a chronic skin disease often affecting hands and/or feet (H&F), which are considered high-impact areas due to significant negative impact on QoL and ability to work. Tralokinumab, a monoclonal antibody specifically targeting interleukin-13, is indicated for treatment of moderate-to-severe AD. Here, we evaluated the impact of tralokinumab in patients with H&F 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 Nov-2021 to Jul-2023) that were 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 H&F at baseline. Outcomes collected included AD localization, and overall AD measures, IGA, DLQI, RECAP, WPAI, Peak Pruritus NRS (PP-NRS), and/or Sleep NRS according to individual clinical practice. Data presented as-observed.

Results: Among patients who had H&F AD at baseline (59.8% of full analysis set), 42.4% (175/413) had no H&F AD at 3 months (M), which increased to 53.3% at 9M. Percentages with IGA 0/1 increased from 0.8% (4/488) at baseline to 32.7% (127/388) at 3M, 45.1% (92/204) at 6M, and 60.9% (56/92) at 9M of tralokinumab. The percentages of patients with IGA 4 decreased from 37.9% (185/488) at baseline to 5.2% (20/388) at 3M, 3.9% (8/204) at 6M, and 3.3% (3/92) at 9M. Among patients with baseline IGA≥2, percentages achieving ≥2-point improvement in IGA increased from 45.4% (164/361) at 3M to 55.4% (108/195) at 6M, and 74.7% (65/87) at 9M. Among patients with baseline DLQI≥6, majority achieved ≥6-point reduction in DLQI with tralokinumab: 59.2% (71/120) at 3M, 60.0% (39/65) at 6M, and 71.1% (27/38) at 9M. In patients with H&F AD, the mean percent overall work impairment due to AD decreased from 29.7% (n=87) at baseline to 16.7% (n=50) at 3M, 13.6% (n=20) at 6M, and 15.2% (n=15) at 9M. Mean PP-NRS improved from 6.5 (n=275) at baseline to 4.4 (n=165) at 3M, 3.5 (n=92) at 6M, and 3.4 (n=54) at 9M. Mean Sleep NRS improved from 5.3 (n=215) at baseline to 2.8 (n=128) at 3M, 2.5 (n=68) at 6M, and 2.3 (n=49) at 9M of tralokinumab. Similar improvements were observed across endpoints in both dupilumab-naive (n=383) and dupilumab-experienced (n=110) patients, despite higher baseline disease severity in dupilumab-naive patients.

Conclusion: Treatment for 9M with tralokinumab cleared H&F AD in more than 50% of patients. Tralokinumab also improved signs, symptoms, QoL, and work productivity in patients with H&F AD in a real-world setting. Dupilumab-naive and dupilumab-experienced patients demonstrated similar improvements with tralokinumab.