INTRODUCTION: Phase 3 clinical trials have demonstrated robust efficacy and favorable safety of upadacitinib for the treatment of atopic dermatitis (AD). However, real-world data are still sparse. The objectives of this study were to assess the effectiveness and safety of real-world treatment with upadacitinib in patients with moderate-to-severe AD. METHODS: UP-TAINED is an ongoing German prospective, multicenter, observational study in adolescents and adults with moderate-to-severe AD treated with upadacitinib 15 or 30 mg once daily, according to local labeling. Effectiveness (primary endpoint
measured with the Atopic Dermatitis Control Tool [ADCT]) and safety are assessed over 2 years. Reported here are 1-year results from an interim analysis. RESULTS: Data on 351 patients were included in the effectiveness analysis. At 12 weeks, 71.0% of patients had achieved disease control (ADCT total score <
7)
at 1 year, this rate was 70.9%. An Eczema Area and Severity Index (EASI) ≤ 3 was achieved by 60.6% of patients after 4 weeks and 68.1% after 1 year of upadacitinib treatment. Of 186 patients with moderate-to-severe facial eczema at baseline and 142 patients with moderate-to-severe hand eczema at baseline, 60.8% (101/166) and 63.8% (83/101) achieved clear or almost clear skin in those respective body regions after 4 weeks of upadacitinib treatment. Of the 380 patients included in the safety analysis, 163 patients reported 426 adverse events (AEs), most classified as mild (59.7%) or moderate (34.6%). The most common AEs were (worsening of) AD, acne, and COVID-19. No major cardiovascular AEs, venous thromboembolism, or malignancies were reported. CONCLUSIONS: Upadacitinib was well tolerated, and the majority of patients with moderate-to- severe AD receiving upadacitinib in real-world clinical practice achieved stringent treatment goals with early and up to 1-year disease control attained, particularly in difficult-to-treat areas such as hand and face. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05139836.