Real-world characterization of early and delayed responses to tralokinumab among patients with atopic dermatitis: Results from the prospective, international, non-interventional 12-month TRACE study

Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin condition associated with negative impacts on several aspects of patients’ lives. Interleukin (IL)-13 is a key driver of skin inflammation in AD. Phase 3 trials demonstrated that tralokinumab, an IL-13-targeting monoclonal antibody, was effective and well tolerated, leading to its approval for patients ≥12 years of age with moderate-to-severe AD. To date, TRACE is the largest non-interventional, real-world study of tralokinumab in adults with AD. This analysis aimed to describe early and non-early responses to tralokinumab among patients with AD in a real-world setting. Methods: In the international, non-interventional TRACE study adults with AD were prescribed tralokinumab and followed for up to 12 months. Assessments were conducted per local practice at baseline and every 3 months. Investigator-assessed outcomes included Investigator Global Assessment (IGA) score, Eczema Area and Severity Index (EASI), and SCORing Atopic Dermatitis (SCORAD). Patient-reported outcomes (PROs) included Dermatology Life Quality Index (DLQI), peak pruritus numerical rating scale (PP-NRS), and Sleep-NRS. Patients achieving any of the following were considered composite responders: EASI ≤7, IGA 0/1, or SCORAD <10. Subpopulations in this analysis were early responders (achieving composite response at 3 months) and non-early responders (not achieving composite response at 3 months). Data are presented as observed. Results: TRACE enrolled 824 patients. At Month 3, 60.7% (430/708) were composite responders, and 32.3% (229/708) had not yet achieved composite response. Baseline demographics were comparable between the two groups. Overall, non-early responders had more severe disease at baseline (mean [SD] EASI 24.0 [10.9] vs. 18.8 [10.6]) and were more likely to be biologic-experienced (27.9%, n=229 vs. 20%, n=430) compared with early responders. Of the 430 patients achieving early (Month 3) composite response, 91% (n=288, 95% CI: 87-94) also had a composite response at Month 12. Among patients who did not achieve a composite response at Month 3, composite response was met by 51% (n=162, 95% CI: 43-59) at Month 6, and 76% (n=107, 95% CI: 66-83) at Month 12. Both early and non-early responder subpopulations achieved improvements in PROs by Month 12. DLQI ≥4-point improvement was met by 76% (n=99, 95% CI: 66-84) of early responders and 81% (n=36, 95% CI: 64-92) of non-early responders, PP-NRS ≥4-point improvement by 53% (n=87, 95% CI: 42-64) of early responders and 51% (n=39, 95% CI: 35-68) of non-early responders, and Sleep-NRS ≥2-point improvement by 72% (n=68, 95% CI: 60-82) of early responders and 68% (n=25, 95% CI: 46-85) of non-early responders. Conclusion: Overall, these results support the early and long-term effectiveness of tralokinumab for up to 12 months in a real-world setting. Of patients who demonstrated a clinical response at 3 months of treatment, over 90% also had a response at 12 months, and 76% of patients who did not meet early response criteria were able to achieve the composite response by 12 months of treatment. These findings offer valuable insights into tralokinumab responsiveness for clinicians managing patients with moderate-to-severe AD.