Augustin Matthias, Bauer Andrea, Ertner Konstantin, von Kiedrowski Ralph, Schenck Florian, Ramaker-Brunke Jutta, Möller Sophie, Fait Anja, Bastian Mike, Thaçi Diamant
Institute of Health Care Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Dermatology, University Allergy Centre, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany.
Dermatol Ther (Heidelb). 2023 Mar;13(3):803-816. doi: 10.1007/s13555-023-00894-3. Epub 2023 Feb 4.
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.
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]).
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.
Improvements in efficacy outcomes and adverse event rates in a real-world setting were more favourable than in phase 3 clinical trials.
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.
DUPILL08907; NIS-Nr. 433.
在随机对照临床试验中，度普利尤单抗显著改善了中度至重度特应性皮炎（AD）患者的体征、症状和生活质量（QoL）。然而，有必要评估度普利尤单抗在实际临床实践中的有效性和安全性。PROLEAD研究旨在考察度普利尤单抗在德国实际临床环境中治疗中度至重度AD的有效性和安全性。在此，我们呈现PROLEAD研究中使用度普利尤单抗12周的有效性和安全性结果。
PROLEAD是一项在德国126个常规护理点开展的多中心、前瞻性、非干预性研究。需要全身治疗的中度至重度AD成人患者按照产品特性摘要的指示接受度普利尤单抗治疗。收集的数据包括医生评估（湿疹面积和严重程度指数[EASI]、体表面积[BSA]、特应性皮炎评分[SCORAD]和医师全面评估[IGA]）以及患者报告的结局（PROs[瘙痒障碍评估量表[POEM]、皮肤病生活质量指数[DLQI]、欧洲五维健康量表[EQ-5D-5L]、瘙痒峰值数字评定量表[NRS]和医学结局研究睡眠量表]）。
在839例评估是否符合纳入标准的患者中，828例被纳入。完整分析集和安全性分析集分别包括775例和818例患者。接受联合治疗的患者数量从基线至第12周减少。从基线至第12周，EASI评分的平均（标准差[SD]）百分比变化为-67.5%（48.4%），在四个身体区域中相当。在第12周时，达到EASI-75的患者比例为59.4%。瘙痒峰值NRS的平均（SD）值从基线时的7.4（2.3）降至第12周时的3.4（2.6）。在所有评估的PROs中，均报告了从基线至第12周的改善情况。未观察到新的安全信号。
在实际临床环境中，疗效结局和不良事件发生率方面的改善比3期临床试验中更有利。
PROLEAD研究的12周结果表明，度普利尤单抗治疗有效且耐受性良好，在实际临床中，中度至重度AD患者的体征、症状和生活质量方面起效迅速。
DUPILL08907；国家识别号433。
