Long-Term Safety and Efficacy of Tralokinumab in Patients with Moderate-to-Severe Atopic Dermatitis Treated for up to 6 Years: Final Results from the Open-Label Extension Trial ECZTEND

INTRODUCTION: Atopic dermatitis (AD) is a chronic inflammatory skin disease often requiring continuous therapy. The objective with the ECZTEND trial was to assess the long-term safety and efficacy of tralokinumab treatment. METHODS: ECZTEND was a multicountry, open-label, 5-year extension trial conducted from September 2018 to July 2024 in patients (≥ 12 years) with moderate-to-severe AD who had received up to 1 year of tralokinumab treatment in a parent trial. Patients were eligible regardless of previous randomization (tralokinumab or placebo) or treatment response in the parent trial. The primary endpoint was the number of treatment-emergent adverse events (TEAEs) through week 268. Key secondary endpoints were Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) through week 248. RESULTS: In total, 1672 patients were enrolled (4466.2 patient-years of exposure; median 2.6 years). Overall, 68.4% of patients (n = 1143) completed the trial period they consented to; 7.1% (n = 117) discontinued owing to lack of efficacy; and 4.2% (n = 72) owing to adverse events. The TEAE incidence rate was 114.3/100 patient-years with a pattern consistent with that observed in the parent trials albeit at lower rates. The majority (> 97%) of TEAEs were nonserious and of mild or moderate severity. Most (> 80%) were assessed as not related to tralokinumab by the investigator and resolved by the end of the trial. Common TEAEs (≥ 5%) included nasopharyngitis, atopic dermatitis, coronavirus infection, upper respiratory tract infection, conjunctivitis, and headache. The proportions of patients with IGA 0/1 and EASI-75/EASI-90 increased during the first 16 weeks and then remained stable through week 248 at ≥ 50% for IGA 0/1 and EASI-90, and ≥ 80% for EASI-75. CONCLUSIONS: Long-term tralokinumab treatment for up to 6 years (parent trials plus ECZTEND) in patients ≥ 12 years with moderate-to-severe AD was well tolerated and maintained long-term efficacy. A graphical abstract is available for this article. TRIAL REGISTRATION: Clinicaltrials.gov listing: NCT03587805 (ECZTEND). Atopic dermatitis (AD) is a long-lasting, itchy skin disease where patients often experience periods of worsening symptoms that negatively impact their quality of life. Tralokinumab is a medication approved for treating adults and adolescents with moderate-to-severe AD. This study looks at the long-term safety and efficacy of patients (aged 12 years or older) with moderate-to-severe AD treated for up to 6 years with tralokinumab. In total, 1672 patients were treated with tralokinumab for 1 year in a clinical trial plus up to 5.1 years in the ECZTEND long-term extension trial. During long-term treatment, the safety profile for tralokinumab was consistent with that seen in clinical trials. Common side effects included symptoms of common cold, worsening of AD, conjunctivitis (pink eye), and headache. Nearly all side effects (>97%) were nonserious and of mild or moderate severity. Most (>80%) were assessed as not related to tralokinumab by the study investigator, and resolved by the end of the trial. AD severity decreased during the first 3 months of the ECZTEND trial, after which more than half of patients reported “clear” or “almost clear” skin (measured by Investigator’s Global Assessment IGA score of 0 or 1) and >80% reported Eczema Area and Severity Index EASI-75 (≥ 75% reduction in EASI) throughout the trial (approximately 4.7 years 248 weeks of treatment). In conclusion, tralokinumab treatment for up to 6 years was well tolerated and provided stable control of AD signs and symptoms in patients aged 12 years or older with moderate-to-severe AD.