633 - Physician-assessed effectiveness and safety in adolescent and adult atopic dermatitis patients treated with dupilumab: real-world insights one year into the GLOBOSTAD multinational prospective observational study

Abstract Introduction Dupilumab demonstrated robust efficacy in patients with moderate-to-severe atopic dermatitis (AD) in randomized controlled trials. Long-term effectiveness of dupilumab in real-world AD treatment is one of the main objectives of the ongoing GLOBOSTAD study. Objective To report dupilumab effectiveness, through physician-assessed AD clinical tools that measure disease severity over time, and a summary of adverse events in patients one year after initiating treatment. Methods The GLOBOSTAD five-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (M; ±1M), 6M (±2M), and 12M (±2M). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations. Results 758/863/705 patients completed ≥1 follow-up assessment at 3M/6M/12M, respectively. During the study, mean (SD) eczema area and severity index (EASI; >21 = severe; ≤7 = mild/no disease) score rapidly improved from 25.1 (12.8) at baseline to 6.1 (8.0) at 3M, and was sustained until the end of observation period [12M; 4.2 (8.4)]. Similarly, scoring of atopic dermatitis (SCORAD; >50 = severe; <25 = mild/no disease) score improved from 59.3 (16.6) at baseline to 25.3 (16.4) at 3M, further improving to [17.6 (13.0)] at 12M. Adverse events considered related to dupilumab by the investigator were reported in 187 (19.6%) patients. Adverse events leading to permanent dupilumab discontinuation were reported in 23 (2.4%) patients. Conclusion In a real-world scenario, clinical AD assessments rapidly improved upon initiating dupilumab treatment, and were sustained through the end of the one-year observation period. Safety data were consistent with previous studies.