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).