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Introduction: Dupilumab has significantly improved the signs, symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in randomised, controlled clinical trials. However, there is a need to assess the effectiveness and safety of dupilumab in real-world clinical practice. The PROLEAD study was designed to examine the effectiveness and safety of dupilumab in moderate-to-severe AD in a real-world setting in Germany. Here, we present 12-week effectiveness and safety results with dupilumab from PROLEAD. Methods: PROLEAD is a multicentre, prospective, non-interventional study being conducted at 126 routine care sites across Germany. Adults with moderate-to-severe AD who require systemic therapy were treated with dupilumab as indicated by the Summary of Product Characteristics. Data collected included physician assessments (EASI, BSA, SCORAD, and IGA) and patient-reported outcomes (PROs [POEM, DLQI, EQ-5D-5L, Peak Pruritus NRS and MOS Sleep Scale]). Results: Of 839 patients assessed for eligibility, 828 were included. The full analysis and safety analysis sets comprised 775 and 818 patients, respectively. The number of patients receiving concomitant therapy decreased from baseline to Week 12. Mean (standard deviation [SD]) percentage change in EASI score from baseline to Week 12 was –67.5% (48.4%) and was comparable across the four body regions. The proportion of patients achieving EASI-75 was 59.4% at Week 12. Mean (SD) Peak Pruritus NRS decreased from 7.4 (2.3) at baseline to 3.4 (2.6) at Week 12. Improvements from baseline to Week 12 were reported in all PROs assessed. No new safety signals were observed. Discussion: Improvements in efficacy outcomes and adverse event rates in a real-world setting were more favourable than in phase 3 clinical trials. Conclusions: The 12-week findings of PROLEAD demonstrate that treatment with dupilumab is effective and well tolerated, with rapid onset of action in signs, symptoms and QoL in patients with moderate-to-severe AD in the real world. Trial Registration Number: DUPILL08907; NIS-Nr. 433. [ABSTRACT FROM AUTHOR]

Introduction: Dupilumab is the first biologic licensed to treat patients with moderate-to-severe atopic dermatitis (AD) who require systemic therapy. PROLEAD was designed to document the real-world effectiveness and safety of dupilumab in patients with moderate-to-severe AD. The present study aims to describe the baseline characteristics of patients treated with dupilumab in Germany. Methods: PROLEAD is a national, multicentre, prospective, non-interventional study, with a 2-year observation period. Adults with moderate-to-severe AD treated with dupilumab were included. Baseline characteristics, physician assessments, and patient-reported outcomes (PROs) were collected. Results: The study involved 126 sites throughout Germany. Of 839 patients assessed for eligibility, 828 were included, with baseline data available for 817 patients. Mean (standard deviation, SD) age of patients was 43.4 (15.8) years, with 396 (48.5%) patients being female. Overall, 66.6% of patients received their first diagnosis of AD during childhood. In total, 423 (51.8%) patients had co-existing atopic and type 2 inflammatory diseases, including allergic conjunctivitis (36.8%) and bronchial asthma (22.5%). Overall, 61.4% of patients had received systemic therapy, most commonly oral corticosteroids (49.9%). Approximately half of patients (51.3%) had received UV/phototherapy prior to baseline. Treatment with moderate-potent (Class 2) or potent (Class 3) topical corticosteroids was the most common concomitant treatment at baseline. However, 50.4% of patients had not received concomitant AD treatment with dupilumab at baseline. The most reported reason for initiating dupilumab was "Topical therapy alone was not sufficient" (95.1%). Mean (SD) physician assessments: EASI: 22.9 (14.5); SCORAD: 63.3 (16.2); IGA: 3.3 (0.7). Mean (SD) PROs: DLQI: 13.9 (7.1); peak pruritus NRS: 7.4 (2.3). Conclusions: Patients with moderate-to-severe AD present a long medical history, impaired quality of life, and high prevalence of co-existing type 2 inflammatory diseases. Dupilumab was used as a first-line systemic treatment in 38.6% of patients. [ABSTRACT FROM AUTHOR]