Calabrese Laura, Cinotti Elisa, D'Onghia Martina, Cartocci Alessandra, Rubegni Pietro, Maccari François, Boulard Claire, Reguiai Ziad, Becherel Pierre-André, Jacobzone Caroline, Begon Edouard, Fite Charlotte, Walls Beatrice, Liegeon Anne Laure, Parier Josiane, Chaby Guillaume, Perrot Jean-Luc
Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy; Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.
Acta Derm Venereol. 2025 Mar 12;105:adv42275. doi: 10.2340/actadv.v105.42275.
Tralokinumab is a monoclonal antibody selectively targeting IL-13, approved for moderate-to-severe atopic dermatitis (AD), for which real-world data are scarce. This prospective, observational, multicentric study aimed to assess the long-term effectiveness and safety of tralokinumab in patients with AD in a real-world setting. Primary outcomes included 50%, 75%, and 90% improvement in Eczema Area and Severity Index score (EASI50, EASI75, EASI90, respectively) and improvements in Dermatology Life Quality Index (DLQI) at 1 year. A total of 136 patients with AD were enrolled in the study; data at 1-year follow-up were available for 111 patients. After 1 year, 68.5% and 33.3% of patients achieved an EASI75 and EASI90, respectively. A significantly higher percentage of patients with than without foot involvement achieved EASI50 (p = 0.009) and EASI75 (p = 0.022). Similarly, hand involvement was significantly associated with higher EASI50 response (p = 0.005). Median DLQI score decreased from 9.00 (interquartile range (IQR): 6.00, 13.75) to 1.00 (IQR: 0.00, 4.00) after 1 year of treatment. Adverse events included blepharitis (n = 10), conjunctivitis (n = 6), and injection-site reactions (n = 2). Tralokinumab can be an effective and safe treatment for patients with moderate-to-severe AD. Involvement of certain body areas, such as hands and feet, might positively predict a clinical response to tralokinumab.
曲罗芦单抗是一种选择性靶向白细胞介素-13的单克隆抗体，已被批准用于治疗中重度特应性皮炎（AD），但关于该药物的真实世界数据较少。这项前瞻性、观察性、多中心研究旨在评估曲罗芦单抗在真实世界环境中对AD患者的长期有效性和安全性。主要结局包括治疗1年后湿疹面积和严重程度指数评分（分别为EASI50、EASI75、EASI90）改善50%、75%和90%，以及皮肤病生活质量指数（DLQI）改善。共有136例AD患者纳入本研究；111例患者有1年随访数据。1年后，分别有68.5%和33.3%的患者达到EASI75和EASI90。足部受累的患者达到EASI50（p = 0.009）和EASI75（p = 0.022）的比例显著高于未受累患者。同样，手部受累与更高的EASI50反应显著相关（p = 0.005）。治疗1年后，DLQI评分中位数从9.00（四分位间距（IQR）：6.00，13.75）降至1.00（IQR：0.00，4.00）。不良事件包括睑缘炎（n = 10）、结膜炎（n = 6）和注射部位反应（n = 2）。曲罗芦单抗对中重度AD患者可能是一种有效且安全的治疗方法。某些身体部位（如手和脚）受累可能对曲罗芦单抗的临床反应有积极预测作用。
