| Abstrakt: |
In several randomized controlled trials, dupilumab demonstrated a robust efficacy and safety profile in patients with moderate-to-severe atopic dermatitis (AD). The ongoing GLOBOSTAD study (NCT03992417) characterizes patients treated with dupilumab, their AD treatment patterns, effectiveness, and safety of dupilumab in the real world. Here, we present comprehensive data on patients enrolled in France. This 5-year, multinational, prospective, observational study enrolled patients aged ≥ 12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. In France, dupilumab is indicated for adults/adolescents with no response to ciclosporin/topical treatments, respectively [1]. Assessments were performed at baseline (BL)/3 months(M; ± 1 M)/6M(± 2 M)/12M(± 2 M). Data are reported as observed for enrollment/safety (n = 94; data cutoff: March 2023) and follow-up (n = 88) populations. Of the 94 patients, 5.3% were aged 12–17 years, 76.6% were 18–39, 14.9% were 40–64, 3.2% were ≥ 65, with mean (standard deviation, SD) age of 30.7(13.0), and 50% female patients. Ciclosporin and topical corticosteroid/calcineurin inhibitors use was reported in 19.1% and 46.8%/9.6% patients, respectively, 12 M before enrollment. 88/59/68 patients completed ≥ 1 follow-up assessment at 3 M/6 M/12 M, respectively. Mean (SD) Eczema Area and Severity Index (> 21 = severe; ≤ 7 = mild/no disease) scores at BL/3 M/12 M were 15.4(10.6)/4.1(4.9)/4.0(7.5). Similarly, SCORing Atopic Dermatitis (> 50 = severe; ≤ 25 = mild/no disease) scores were 51.0(16.5)/23.3(14.6)/17.8(14.2); pruritus Numerical Rating Scale (0–10) scores were 6.1(2.2)/3.1(2.5)/1.7(2.2); and Dermatology Life Quality Index (0–30) scores were 12.8(6.2)/6.0(6.2)/3.5(3.8). Adverse events considered related to dupilumab were reported in 37.2% patients and led to permanent discontinuation in 2.1%. In the year prior to enrollment, ciclosporin use was reported in few, and topical treatment use in about half of the patients. On dupilumab initiation, AD clinical scores rapidly improved and were sustained until end of observation period. Safety data were consistent with previous studies. [ABSTRACT FROM AUTHOR] |
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