Barei Francesca, Calzari Paolo, Pezzolo Elena, Napolitano Maddalena, Rossi Mariateresa, Guanti Mario Bruno, Caroppo Francesca, Belloni Fortina Anna, Patruno Cataldo, Campanati Anna, Bianchelli Tommaso, D'Agostino Giovanni Marco, Nettis Eustachio, Pugliese Francesco, di Vico Francesca, Trave Ilaria, Cozzani Emanuele, Stingeni Luca, Hansel Katharina, Dall'Olio Matilde, Grigolato Laura, Coppola Rosa, Panasiti Vincenzo, Maurelli Martina, Girolomoni Giampiero, Ortoncelli Michela, Ribero Simone, Marzano Angelo Valerio, Ferrucci Silvia Mariel
Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Department of Pathophysiology and Transplantation, Università degli Studi di Milano, 20122 Milan, Italy.
J Clin Med. 2025 Mar 18;14(6):2077. doi: 10.3390/jcm14062077.
: Tralokinumab, a fully human monoclonal antibody targeting IL-13, has shown efficacy and safety in clinical trials and real-life studies for atopic dermatitis (AD). However, data on its effectiveness across AD phenotypes are limited. : A multicentric study evaluated tralokinumab's efficacy over 52 weeks in 416 severe AD patients. EASI (Eczema Area and Severity Index), P-NRS (Pruritus Numerical Rating Scale), DLQI (Dermatology Life Quality Index), and ADCT (Atopic Dermatitis Control Tool) were recorded up to 52 weeks of treatment. : The EASI, P-NRS, DLQI, and ADCT trends across phenotypes showed significant improvement in all phenotype subgroups. By week 16, classical and generalized lichenoid phenotypes showed the highest EASI improvements compared to the generalized inflammatory (75.0 vs. 45.5 [ < 0.001] and 79.3 vs. 45.5 [ < 0.001]), with most achieving EASI-75 ( < 0.001, χ = 25.96). By week 24, generalized lichenoid reached 100% EASI improvement, significantly outperforming other phenotypes. The highest EASI-75 rates were seen in classical, generalized lichenoid, and portrait/head and neck phenotypes ( = 0.016, χ = 13.85). No significant differences were observed at weeks 32, 40, or 52. : Our results suggest that tralokinumab's durability and tolerability are consistent across the various phenotypes. The classical and generalized lichenoid were the fastest phenotypes to improve. However, given the uneven distribution of phenotypes and the gradual reduction in patient numbers over time, larger prospective studies are essential to confirm the observed trends.
曲罗芦单抗是一种靶向白细胞介素-13的全人单克隆抗体，已在特应性皮炎（AD）的临床试验和真实世界研究中显示出疗效和安全性。然而，关于其在不同AD表型中的有效性数据有限。
一项多中心研究评估了曲罗芦单抗在416例重度AD患者中52周的疗效。在长达52周的治疗期间记录湿疹面积及严重程度指数（EASI）、瘙痒数字评定量表（P-NRS）、皮肤病生活质量指数（DLQI）和特应性皮炎控制工具（ADCT）。
各表型的EASI、P-NRS、DLQI和ADCT趋势显示所有表型亚组均有显著改善。到第16周时，经典型和泛发性苔藓样表型的EASI改善程度最高，与泛发性炎症型相比（分别为75.0对45.5[<0.001]和79.3对45.5[<0.001]），大多数达到EASI-75（<0.001，χ=25.96）。到第24周时，泛发性苔藓样表型的EASI改善率达到100%，显著优于其他表型。经典型、泛发性苔藓样表型以及面部/头颈部表型的EASI-75率最高（=0.016，χ=13.85）。在第32周、40周或52周时未观察到显著差异。
我们的结果表明，曲罗芦单抗在不同表型中的疗效持久性和耐受性是一致的。经典型和泛发性苔藓样表型是改善最快的表型。然而，鉴于表型分布不均以及患者数量随时间逐渐减少，需要更大规模的前瞻性研究来证实所观察到的趋势。
