Tolino Ersilia, Ambrosio Luca, Bernardini Nicoletta, Proietti Ilaria, Skroza Nevena, Potenza Concetta
Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", "Sapienza" University of Rome, Polo Pontino, 04100, Latina, Italy.
IDI-IRCCS, Dermatological Research Hospital, 00167, Rome, Italy.
Dermatol Ther (Heidelb). 2025 Feb;15(2):337-350. doi: 10.1007/s13555-025-01341-1. Epub 2025 Jan 25.
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus and a relapsing course, affecting approximately 25% of children and 4-7% of adults. This study evaluated the efficacy, safety, and quality-of-life impact of tralokinumab, a humanized monoclonal antibody targeting interleukin-13 (IL-13), in treating moderate-to-severe AD in a real-world setting, with a focus on different AD phenotypes.
An observational cohort of 30 adults treated with tralokinumab for ≥ 16 weeks was analyzed. Clinical and demographic data were collected, and outcomes were assessed using the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and numeric rating scales (NRS) for pruritus and sleep disturbances.
By week 16, 60% achieved a 75% improvement in EASI (EASI75) and 31% reached a 90% improvement in EASI (EASI90), reflecting substantial clinical improvements. A ≥ 4-point reduction in pruritus NRS was observed in 63% of patients by week 16, increasing to 70% by week 32. Similarly, 75% achieved significant improvements in sleep disturbance NRS by week 16, with sustained effects through week 32. Subgroup analysis revealed superior clinical responses in patients with early-onset AD and atopic comorbidities. Lower total immunoglobulin E (IgE) levels at week 16 correlated with better outcomes, suggesting total IgE as a potential biomarker. By week 32, 70% of patients had a DLQI ≤ 5, indicating minimal quality-of-life impact. Additionally, 88% reached at least one therapeutic target, and 81% met composite endpoints combining clinician-assessed and patient-reported outcomes. The safety profile was consistent with clinical trials, with mild conjunctivitis and injection site reactions as the most common adverse events.
These findings support tralokinumab as an effective and well-tolerated treatment, emphasizing the importance of phenotype-specific approaches in AD management.
特应性皮炎(AD)是一种慢性炎症性皮肤病,其特征为瘙痒和病程反复,影响约25%的儿童和4 - 7%的成年人。本研究评估了靶向白细胞介素-13(IL-13)的人源化单克隆抗体曲罗芦单抗在真实世界中治疗中度至重度AD的疗效、安全性及对生活质量的影响,重点关注不同的AD表型。
分析了30例接受曲罗芦单抗治疗≥16周的成年患者组成的观察性队列。收集了临床和人口统计学数据,并使用湿疹面积和严重程度指数(EASI)、皮肤病生活质量指数(DLQI)以及瘙痒和睡眠障碍的数字评定量表(NRS)对结局进行评估。
到第16周时,60%的患者实现了湿疹面积和严重程度指数改善75%(EASI75),31%的患者实现了EASI改善90%(EASI90),这反映出显著的临床改善。到第16周时,63%的患者瘙痒NRS降低≥4分,到第32周时增至70%。同样,75%的患者到第16周时睡眠障碍NRS有显著改善,且这种效果持续到第32周。亚组分析显示早发型AD和特应性合并症患者的临床反应更佳。第16周时较低的总免疫球蛋白E(IgE)水平与更好的结局相关,提示总IgE作为一种潜在的生物标志物。到第32周时,70%的患者皮肤病生活质量指数(DLQI)≤5,表明对生活质量的影响最小。此外,88%的患者达到至少一个治疗目标,81%的患者达到结合临床医生评估和患者报告结局的综合终点。安全性概况与临床试验一致,轻度结膜炎和注射部位反应是最常见的不良事件。
这些发现支持曲罗芦单抗是一种有效且耐受性良好的治疗方法,强调了AD管理中表型特异性方法的重要性。