Real-World Effectiveness and Safety of 12 Months of Tralokinumab in Patients with Atopic Dermatitis.

INTRODUCTION

Atopic dermatitis (AD) is a chronic, inflammatory skin condition in which interleukin (IL)-13 is a key driver. Tralokinumab, an IL-13-targeting monoclonal antibody, has demonstrated efficacy and a favorable safety profile in patients with moderate-to-severe AD in phase 3 trials. However, data on long-term effectiveness and safety in routine clinical practice remain limited. This study aimed to assess changes in clinical signs and symptoms of AD and evaluate safety in patients treated with tralokinumab in a real-world setting.

METHODS

TRACE is an international, non-interventional, prospective study of adults with AD prescribed tralokinumab and followed for up to 12 months of treatment. The primary outcome was investigator-assessed AD severity (Investigator's Global Assessment [IGA], Eczema Activity and Severity Index [EASI], and/or SCORing AD [SCORAD]). Patient-reported outcomes (PROs) were collected if part of routine practice. Safety was also assessed.

RESULTS

A total of 824 patients (mean age 44.1 years; 24.9% with prior biologic therapy) were included. At baseline, 414 (50.3%) patients had moderate AD (IGA 3), 281 (34.1%) had severe AD (IGA 4), mean EASI was 20.1, and mean SCORAD was 47.1. Early improvements in AD clinical signs and symptoms were sustained over 12 months of treatment with tralokinumab, with the percentage of composite responders (IGA 0/1, EASI-75, or SCORAD < 10) increasing from 5.3% at baseline to 79.1% at month 12. Rapid and sustained improvements in PROs were also reported throughout the study. AEs were reported by 232 (28.1%) patients, with the majority being non-serious and mild or moderate in severity. Conjunctivitis was reported in 4.4% of patients.

CONCLUSIONS

TRACE is the largest real-world study of tralokinumab to date. Treatment with tralokinumab over 12 months substantially improved signs and symptoms of AD as well as PROs across all outcome measures, providing evidence supporting the rapid and long-term effectiveness of tralokinumab. No new safety signals were identified.

TRIAL REGISTRATION: EU PAS register-EUPAS44659.