10 | LEBRIKIZUMAB PROVIDES CLINICALLY MEANINGFUL RESPONSE IN FACE AND HANDS IN ADULTS AND ADOLESCENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS: ADHOPE 1 STUDY

L. Stingeni¹, C. Vestergaard², J. Seneschal^3|4, S. Weidinger⁵, A. Wollenberg^6|7|8, A. Irvine⁹, H. Agell¹⁰, J. Valls Bancells¹⁰, V. Sapena¹⁰, D. Thaçi⁷ | ¹Dermatology Section, Department of Medicine and Surgery, University of Perugia, Italy; ²Department of Dermatology and Venerology, Aarhus University Hospital, Aarhus, Denmark; ³Department of Dermatology, University of Bordeaux, Bordeaux, France; ⁴Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin Disorders, Hospital Saint-André, Bordeaux, France; ⁵Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany; ⁶University Medical Center of Augsburg, Augsburg, Germany; ⁷Institute and Comprehensive Center for Inflammatory Medicine at the University of Lübeck, Lübeck, Germany; ⁸Department of Dermatology and Allergology, LMU Hospital, Munich, Germany; ⁹Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland; ¹⁰Almirall S.A., Barcelona, Spain

Most patients (pts) with atopic dermatitis (AD) have face and/or hands involvement, posing a major psychological burden(1). Lebrikizumab (LEB), a monoclonal antibody that selectively targets interleukin-13, is approved for moderate-to-severe (mod-sev) AD(2-4). We report LEB efficacy in face and hands from ADhope 1 (NCT05990725). ADhope 1 was a 24-Week(W), open-label study in adults and adolescents (12–17 years, ≥40kg), Eczema Area and Severity Index (EASI) ≥12, Investigator’s Global Assessment (IGA) ≥3, ≥10% body surface area AD involvement, who were not adequately controlled with topical therapies. Prior dupilumab use was allowed. Pts received 500mg at baseline (BL) and W2, then 250mg every 2 weeks (Q2W) until W16, then 250mg Q4W until W24. Topical corticosteroid use was allowed. Outcomes included Face IGA 0/1 with ≥2-point improvement from BL, and Face IGA ≥1-point improvement from BL in pts with Face IGA≥2 at BL, and percent change from BL in modified Total Lesion Symptom Score (mTLSS) to assess response in hands. Treatment discontinuation due to lack of efficacy was classed as non-response; other discontinuations and missing data were handled by multiple imputation. Data collected after prohibited medication use were included. Efficacy was assessed in 247/260 enrolled pts (13 pts excluded due to quality issues). At BL, mean age (standard deviation [SD])=32.8 (14.1) years, 61.1% male, 8.5% had prior dupilumab exposure. Mean (SD) EASI=23.1 (9.0), mean (SD) Pruritus Numerical Rating Scale=6.7 (1.6), IGA scores of 3 (moderate) and 4 (severe) were reported in 74.1% and 25.9% of pts, respectively. 69.6% of pts had Face IGA ≥2 (15.8% Face IGA=2, mild; 42.5% Face IGA=3, moderate; 11.3% Face IGA=4, severe). 64.0% had AD in their hands (mean [SD] BL mTLSS=9.7 [4.1]). Of pts with Face IGA ≥2 at BL (n=172), 79.1% achieved Face IGA ≥1-point improvement at W24 and 44.8% achieved Face IGA 0/1 with ≥2-point improvement at W24 (Fig. 1). Face response correlated with overall body response. Of pts with AD in the hands at BL (n=158), mean percent change from BL in mTLSS progressively increased over time and was −66.3% at W24. LEB provided improvements in AD affecting the face and/or hands. Almost half of the population achieved clear/almost clear skin on the face within 24W of treatment. Findings indicate that LEB is an effective treatment option for pts with mod-sev AD, including those with facial and hand involvement. This study was funded by Almirall, S.A.