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

Résumé fourni par la source

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. 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. 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. 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. EU PAS register—EUPAS44659. Atopic dermatitis (AD) is a common, chronic skin disease that can cause significant inflammation, redness, and itch, and a considerable burden on a patient’s everyday life. Tralokinumab is an injectable medicine approved for treating moderate-to-severe AD in patients whose disease is not controlled by topical prescription medicines alone. Tralokinumab has been extensively studied and found to be effective and well tolerated in clinical trial settings. The TRACE study aimed to evaluate how effective tralokinumab was in patients treated in routine healthcare settings across 11 countries. Both patients and their treating physicians were asked to provide data on AD disease severity and the impact on quality of life. In total, 824 patients with AD were studied. About half of patients had substantial improvements in their symptoms, as assessed by their doctor, within the first 3 months of starting tralokinumab treatment. Improvements continued throughout the 12-month treatment period, with 66% of patients achieving ratings of clear or almost clear skin, and 79% of patients showing at least a 75% improvement in symptoms. Marked improvements were also reported by patients within 3 months of treatment, including in quality of life, itching, pain, sleep and work productivity, which were sustained or continued to improve over the 12-month study period. Importantly, no new safety concerns were found. Altogether, the TRACE study showed that in real-world clinical practice, tralokinumab was effective in improving the symptoms of AD and quality of life for adult patients with AD.

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