Augustin Matthias, Serra-Baldrich Esther, Seneschal Julien, Grond Susanne, Lampropoulou Anastasia, Elrayes Mohamed, Ogwu Samuel, de la Torre Inmaculada, Bewley Anthony, Pinter Andreas
Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Department of Dermatology, Cutaneous Allergy Unit, Hospital de la Santa Crue i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Adv Ther. 2025 Jun;42(6):2728-2738. doi: 10.1007/s12325-025-03137-3. Epub 2025 Apr 7.
AD-REAL is an ongoing 1-year multinational observational cohort study evaluating oral systemic therapies in the management of adults with atopic dermatitis (AD) in a real-world practice across four European countries. Herein, we provide insights on baseline disease characteristics and treatment patterns of patients treated with oral systemic therapies, including baricitinib.
AD-REAL included adults with moderate-to-severe AD for ≥ 6 months, who were initiated on an oral systemic treatment in clinical practice and enrolled either in the baricitinib or the other oral systemic (OOS) cohort. Here, we report baseline characteristics, including clinician-assessed outcomes (Eczema Area and Severity Index [EASI]) and patient-reported outcomes (PROs), and explore AD subgroups based on body surface area (BSA) ≤ 40% and Itch numerical rating scale (NRS) ≥ 7. Continuous outcomes were reported using mean and standard deviation (SD) and categorical variables using frequencies. Baseline continuous variables with missing data were imputed using the multiple imputation method.
Baseline demographics were consistent across both baricitinib and OOS cohorts. Patients showed long disease duration (26.2 years), refractory to several systemic options, and a moderate EASI mean (SD) score of 17.5 (10.7). The majority (53.7%) presented with severe Validated Investigator Global Assessment (vIGA) and highly impacted Dermatology Life Quality Index (DLQI) score (14.0 [7.1]). At baseline, patients were predominantly female, with AD mainly affecting face/neck (89.4%) and upper extremities (90.3%). About 68.4% presented with BSA ≤ 40 and 33.8% with BSA ≤ 40 and Itch NRS ≥ 7. From those with BSA ≤ 40% and Itch NRS ≥ 7, 63.9% were treated with Janus kinase inhibitors (JAKi).
This analysis provides key information on baseline disease characteristics of patients treated with oral systemics, including baricitinib. Most patients treated with oral systemics in AD-REAL had long-lasting disease, refractory to systemic therapies, with moderate skin affectation but severe itch and impact on quality of life. AD-REAL is the first study to show many patients in real-world practice who are treated with oral systemics present with BSA ≤ 40 and Itch NRS ≥ 7, and most of these patients were treated with JAKi.
AD-REAL是一项正在进行的为期1年的多国观察性队列研究，旨在评估在四个欧洲国家的实际临床实践中，口服全身治疗药物用于成人特应性皮炎（AD）管理的效果。在此，我们提供了接受包括巴瑞替尼在内的口服全身治疗药物的患者的基线疾病特征和治疗模式的相关见解。
AD-REAL纳入了中度至重度AD病程≥6个月的成人患者，这些患者在临床实践中开始接受口服全身治疗，并被纳入巴瑞替尼队列或其他口服全身治疗（OOS）队列。在此，我们报告基线特征，包括临床医生评估的结果（湿疹面积和严重程度指数[EASI]）和患者报告的结果（PROs），并基于体表面积（BSA）≤40%和瘙痒数字评定量表（NRS）≥7探索AD亚组。连续结果以均值和标准差（SD）报告，分类变量以频率报告。使用多重填补法对有缺失数据的基线连续变量进行填补。
巴瑞替尼队列和OOS队列的基线人口统计学特征一致。患者病程较长（26.2年），对多种全身治疗方案耐药，EASI平均（SD）评分为17.5（10.7），处于中度水平。大多数患者（53.7%）表现为严重的验证研究者整体评估（vIGA），且皮肤病生活质量指数（DLQI）评分受影响程度高（14.0[7.1]）。基线时，患者以女性为主，AD主要累及面部/颈部（89.4%）和上肢（90.3%）。约68.4%的患者BSA≤40%，33.8%的患者BSA≤40%且瘙痒NRS≥7。在BSA≤40%且瘙痒NRS≥7的患者中，63.9%接受了 Janus激酶抑制剂（JAKi）治疗。
本分析提供了接受包括巴瑞替尼在内的口服全身治疗药物的患者的基线疾病特征的关键信息。在AD-REAL中接受口服全身治疗的大多数患者病程持久，对全身治疗耐药，皮肤受累程度中等，但瘙痒严重且对生活质量有影响。AD-REAL是第一项表明在实际临床实践中，许多接受口服全身治疗的患者BSA≤40%且瘙痒NRS≥7的研究，并且这些患者中的大多数接受了JAKi治疗。
