曲罗芦单抗治疗重度特应性皮炎患者的疗效及药物留存率：一项为期18个月的多中心研究

Efficacy and drug survival of tralokinumab in patients with severe atopic dermatitis: an 18-month multicentre study.

作者信息

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, Picone Vincenzo, Trave Ilaria, Cozzani Emanuele, Stingeni Luca, Hansel Katharina, Dall'Olio Matilde, Galli Benedetta, Coppola Rosa, Panasiti Vincenzo, Maurelli Martina, Girolomoni Giampiero, Ortoncelli Michela, Ribero Simone, Marzano Angelo Valerio, Ferrucci Silvia Mariel

机构信息

Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

出版信息

Clin Exp Dermatol. 2025 Jun 25;50(7):1373-1384. doi: 10.1093/ced/llaf062.

DOI:10.1093/ced/llaf062

PMID:39899459

Abstract

BACKGROUND

Tralokinumab has demonstrated efficacy in the treatment of atopic dermatitis (AD) in clinical trials and real-world settings. However, there are limited data regarding the long-term use of tralokinumab in real-world settings. Here, we report the findings of a multicentre Italian study conducted to address this knowledge gap.

OBJECTIVES

To evaluate the drug survival and efficacy of tralokinumab for up to 18 months in 471 patients with severe AD.

METHODS

Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale, Sleep Disturbance NRS, Dermatology Life Quality Index and Atopic Dermatitis Control Tool (ADCT) scores were recorded for up to 18 months in patients with AD treated with tralokinumab. Drug survival was analysed using the Kaplan-Meier method.

RESULTS

The overall drug survival rate was 81.5% at 12 months. A statistically significantly higher rate of drug survival was found in women (P = 0.006, log-rank = 7.49), in patients with no family history of AD (P = 0.02, log-rank = 5.96) and in patients aged ≥ 60 years (P = 0.02; log-rank = 5.6), when considering drug survival due to inefficacy. We found a significant reduction in the clinical scores evaluated, with patients naïve to biologics or Janus kinase inhibitors (JAKi) showing more rapid improvement. In univariate regression analysis, the following characteristics were associated with an increased likelihood of achieving EASI-75 (≥ 75% improvement in EASI vs. baseline): being a woman [odds ratio (OR) 1.61, 95% confidence interval (CI) 1.03-2.53; P = 0.04], having no atopic comorbidities (OR 1.69, 95% CI 1.03-2.78; P = 0.04), having no family history of AD (OR 1.67, 95% CI 1.05-2.65; P = 0.01) and having received no concomitant systemic treatment in the previous 12 months (OR 22.07, 95% CI 2.80-173.69; P = 0.003). In multivariate analysis, only a lack of concomitant systemic treatment in the previous 12 months remained statistically significant (OR 23.04, 95% CI 2.79-190.05; P = 0.004).

CONCLUSIONS

Significant improvements in clinical scores were found in patients with AD treated with tralokinumab, with patients naïve to biologics or JAKi experiencing more rapid progress.

摘要

背景

在临床试验和实际应用中，曲罗芦单抗已显示出对特应性皮炎（AD）的治疗效果。然而，关于曲罗芦单抗在实际应用中的长期使用数据有限。在此，我们报告一项意大利多中心研究的结果，以填补这一知识空白。

目的

评估471例重度AD患者使用曲罗芦单抗长达18个月的药物留存率和疗效。

方法

记录接受曲罗芦单抗治疗的AD患者长达18个月的湿疹面积和严重程度指数（EASI）、瘙痒数字评定量表、睡眠障碍数字评定量表、皮肤病生活质量指数和特应性皮炎控制工具（ADCT）评分。采用Kaplan-Meier方法分析药物留存率。

结果

12个月时总体药物留存率为81.5%。在因疗效不佳考虑药物留存率时，女性（P = 0.006，对数秩检验= 7.49）、无AD家族史的患者（P = 0.02，对数秩检验= 5.96）和年龄≥60岁的患者（P = 0.02；对数秩检验= 5.6）的药物留存率在统计学上显著更高。我们发现所评估的临床评分有显著降低，初次使用生物制剂或Janus激酶抑制剂（JAKi）的患者改善更快。在单因素回归分析中，以下特征与实现EASI-75（EASI较基线改善≥75%）的可能性增加相关：女性[比值比（OR）1.61，95%置信区间（CI）1.03 - 2.53；P = 0.04]、无特应性合并症（OR 1.69，95%CI 1.03 - 2.78；P = 0.04）、无AD家族史（OR 1.67，95%CI 1.05 - 2.65；P = 0.01）以及在过去12个月未接受过联合全身治疗（OR 22.07，95%CI 2.80 - 173.69；P = 0.003）。在多因素分析中，仅过去12个月未接受联合全身治疗在统计学上仍具有显著意义（OR 23.04，95%CI 2.79 - 190.05；P = 0.004）。