Introduction and ObjectivesTralokinumab—a biological that specifically targets interleukin‐13—is one of the newer advanced systemic treatments for patients with moderate‐to‐severe atopic dermatitis (AD). Although safety and efficacy have been shown in phase‐III clinical trials, daily practice data are needed. Therefore, the aim of this study was to evaluate 28‐week safety and effectiveness, serum proteins and total IgE levels in adult AD patients treated with tralokinumab in daily practice.Materials and MethodsData of all adult AD patients who started treatment with tralokinumab and participated in the BioDay registry were collected at baseline, and after 4,16 and 28 weeks of treatment. Clinical efficacy was evaluated by clinical outcome measures, such as the Eczema Area and Severity Index (EASI) as well as patient‐reported outcome measures, such as the numerical rating scale (NRS) for pruritus. Adverse events were evaluated. In a subgroup of patients, 18 proteins as well as total IgE levels were measured in serum.ResultsA total of 84 patients were included, of whom 39 were dupilumab‐naïve (D‐naïve) and 45 were dupilumab non‐naïve (D‐non‐naïve) patients. All primary outcomes significantly improved during 28 weeks of tralokinumab treatment and the probability of achieving EASI ≤ 7 and NRS‐pruritis ≤ 4 was 75.8% (56.9–88.2) and 51.4% (28.0–74.2), respectively. The disease severity‐associated proteins TARC/CCL17 and PARC/CCL18 decreased during treatment, and total IgE levels significantly decreased in the D‐naïve patients. The most reported adverse events were eye disorders (n = 24, 28.6%). A total of 23 patients (27.4%) discontinued treatment due to adverse events and/or ineffectiveness, with hair loss being the most common adverse event leading to treatment discontinuation (n = 6).ConclusionTralokinumab is an effective treatment for moderate‐to‐severe AD in adult patients, in both dupilumab‐naïve patients and patients who previously failed on dupilumab treatment. The clinical effect is supported by the biological data.

中文翻译：

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Tralokinumab 治疗成人特应性皮炎患者：临床疗效、安全性、血清蛋白和总 IgE 水平的 28 周评估


简介和目标Tralokinumab 是一种专门针对白细胞介素 13 的生物药物，是针对中度至重度特应性皮炎 （AD） 患者的较新的先进全身治疗方法之一。尽管 III 期临床试验已显示出安全性和有效性，但需要日常实践数据。因此，本研究的目的是评估在日常实践中接受 tralokinumab 治疗的成年 AD 患者的 28 周安全性和有效性、血清蛋白和总 IgE 水平。材料和方法在基线时以及治疗 4、16 和 28 周后收集所有开始使用 tralokinumab 治疗并参与 BioDay 登记的成年 AD 患者的数据。通过临床结果测量（例如湿疹面积和严重程度指数 （EASI））以及患者报告的结果测量（例如瘙痒数字评定量表 （NRS））来评估临床疗效。评估不良事件。在患者亚组中，测量了血清中的 18 种蛋白质以及总 IgE 水平。结果共纳入 84 例患者，其中 39 例为 dupilumab 初治 （D‐naïve），45 例为 dupilumab 非初治 （D‐non-naïve） 患者。在 tralokinumab 治疗的 28 周内，所有主要结果均显著改善，达到 EASI ≤ 7 和 NRS 瘙痒炎 ≤ 4 的可能性分别为 75.8% （56.9-88.2） 和 51.4% （28.0-74.2）。治疗期间疾病严重程度相关蛋白 TARC/CCL17 和 PARC/CCL18 降低，D 初治患者总 IgE 水平显著降低。报告最多的不良事件是眼部疾病 （n = 24， 28.6%）。共有 23 名患者 （27.4%） 因不良事件和/或无效而停止治疗，脱发是导致治疗中断的最常见不良事件 （n = 6）。结论Tralokinumab 是治疗成年患者中度至重度 AD 的有效方法，适用于未接受过 dupilumab 治疗的患者和既往接受过 dupilumab 治疗失败的患者。临床效果有生物学数据支持。