Thaçi Diamant, Bauer Andrea, von Kiedrowski Ralph, Schenck Florian, Ertner Konstantin, Möller Sophie, Fait Anja, Bastian Mike, Augustin Matthias
Institute and Comprehensive Centre for Inflammatory Medicine, University of Luebeck, Ratzeburger Alee 160, 23538, Luebeck, Germany.
Department of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany.
Dermatol Ther (Heidelb). 2022 Sep;12(9):2145-2160. doi: 10.1007/s13555-022-00791-1. Epub 2022 Aug 19.
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.
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.
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).
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.
度普利尤单抗是首个被批准用于治疗需要全身治疗的中度至重度特应性皮炎（AD）患者的生物制剂。PROLEAD旨在记录度普利尤单抗在中度至重度AD患者中的真实疗效和安全性。本研究旨在描述德国接受度普利尤单抗治疗患者的基线特征。
PROLEAD是一项全国性、多中心、前瞻性、非干预性研究，观察期为2年。纳入接受度普利尤单抗治疗的中度至重度AD成人患者。收集基线特征、医生评估和患者报告结局（PRO）。
该研究涉及德国各地的126个研究点。在839例评估 eligibility 的患者中，828例被纳入，817例患者有基线数据。患者的平均（标准差，SD）年龄为43.4（15.8）岁，396例（48.5%）为女性。总体而言，66.6%的患者在儿童期首次诊断为AD。共有423例（51.8%）患者合并特应性和2型炎症性疾病，包括过敏性结膜炎（36.8%）和支气管哮喘（22.5%）。总体而言，61.4%的患者接受过全身治疗，最常见的是口服糖皮质激素（49.9%）。约一半患者（51.3%）在基线前接受过紫外线/光疗。在基线时，使用中效（2级）或强效（3级）外用糖皮质激素治疗是最常见的联合治疗。然而，50.4%的患者在基线时未接受度普利尤单抗联合AD治疗。启动度普利尤单抗最常报告的原因是“仅局部治疗不足”（95.1%）。平均（SD）医生评估：湿疹面积和严重程度指数（EASI）：22.9（14.5）；特应性皮炎评分（SCORAD）：63.3（16.2）；医师整体评估（IGA）：3.3（0.7）。平均（SD）PRO：皮肤病生活质量指数（DLQI）：13.9（7.1）；瘙痒峰值数字评分量表（NRS）：7.4（2.3）。
中度至重度AD患者病史长、生活质量受损，合并2型炎症性疾病的患病率高。38.6%的患者将度普利尤单抗用作一线全身治疗。
