Real-world effectiveness in combination with absence of treatment-related adverse events at assessed visits through 12 months of tralokinumab treatment in the non-interventional TRACE study

Introduction: Evaluating effectiveness and safety parameters in combination may provide an additional, more clinically meaningful assessment that better reflects the benefit–risk outcomes relevant to patients and physicians when considering long-term therapy. Tralokinumab, an interleukin-13-targeting monoclonal antibody approved to treat moderate-to-severe atopic dermatitis (AD), demonstrated efficacy and safety in phase 3 clinical trials. To date, TRACE is the largest non-interventional, real-world study of tralokinumab treatment in adults with AD. This analysis investigates a combined outcome integrating effectiveness with safety by assessing the proportion of patients in TRACE who met composite response effectiveness criteria and were free of tralokinumab-related adverse events (AEs) at each visit for up to 12 months of treatment. Methods: TRACE was an international, non-interventional, prospective study of adults with AD prescribed tralokinumab and followed for up to 12 months of treatment. Assessments were conducted per local practice at clinic-set visit schedules at baseline and every 3 months thereafter. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and SCORing Atopic Dermatitis (SCORAD). Patients were considered composite responders if they met at least one of the following: EASI ≤7, IGA 0/1, or SCORAD <10. AEs were collected throughout the study, and treatment relatedness was assessed by the investigator; only AEs considered related to tralokinumab and ongoing at each visit were included in this analysis. An AE was considered ongoing from its start date until its end date or end of study, whichever came first. AEs were assigned to specific visit windows defined as 1.5 months before and after each scheduled visit (eg, Month 3: 1.5-4.5 months, except baseline: 0-1.5 months). The proportion achieving a composite response was calculated as the percentage of patients with a valid assessment of both AEs and composite response at each visit. Data reported as observed. Results: Early improvements in signs and symptoms of AD were sustained over 12 months of tralokinumab treatment. The proportion of patients with a composite response increased from 13% at baseline (108/818) to 65% (430/659) at Month 3 and 86% (356/415) at Month 12. The proportion of patients free of treatment-related AEs at each visit was high and remained stable over time, with 88.1% (624/708) of patients having no tralokinumab-related AEs present at Month 3 and 90.0% (414/460) at Month 12. When effectiveness and safety outcomes were considered in combination, 58.0% (382/659) of patients at Month 3 achieved a composite response and had no ongoing tralokinumab-related AEs, increasing to 78.3% (325/415) at Month 12. Furthermore, when considering patients without ongoing moderate or severe tralokinumab-related AEs, the proportion meeting effectiveness criteria increased to 62.8% (414/659) at Month 3 and 83.6% (347/415) at Month 12. Conclusion: In a real-world setting, after 12 months of tralokinumab, 78.3% of patients met the combined effectiveness–safety endpoint of composite response without tralokinumab-related AEs at the Month 12 assessment. Beyond separate assessments of effectiveness and safety, this combined evaluation may provide complementary and clinically relevant insight into the overall benefit–risk profile of tralokinumab, and support more informed treatment decisions in practice.