Rodriguez Adrian O, Smith Caid Sterling
Advanced Research Experts, PLLC, Nashville, TN, USA.
Nashville Skin: Comprehensive Dermatology Center, 2301 21 st Ave S, Nashville, TN, 37212, USA.
Dermatol Ther (Heidelb). 2025 Jun 3. doi: 10.1007/s13555-025-01445-8.
Atopic dermatitis (AD) is a chronic inflammatory disease requiring long-term management. Biologic therapies have emerged as systemic treatment options for AD, and real-world evidence (RWE) of their use is needed to inform optimal treatment decisions.
A retrospective, single-center case series was conducted including 37 adults with AD who were systemic-naive or inadequately responded to previous AD treatment and had a visit around 1 year after tralokinumab initiation prior to May 2024. Patient demographics, disease characteristics, and treatment history were collected. Outcomes of tralokinumab treatment, including investigator's global assessment (IGA) score, body surface area (BSA), and adverse events (AEs), were extracted from a 2-month visit (defined as 1-3 months) and a 1-year visit (defined as ≥ 10 months) after tralokinumab initiation.
Thirty-seven patients (median age, 58.0 years; 49% male) on tralokinumab for approximately 1 year or longer were included. At baseline, most patients (97% [33/34]) had moderate-to-severe AD (IGA 3 or 4), and median (interquartile range [IQR]) BSA was 10.0% (5.0%; 18.8%); 19% (7/37) of patients were biologic-experienced, having been previously on dupilumab. Most patients (95% [35/37]) transitioned to tralokinumab due to inadequate response to previous treatment. The proportion of patients with IGA score 0 or 1 increased from 0% (0/34) at baseline to 85% (22/26) after 2 months and 93% (28/30) at 1 year of tralokinumab treatment. Median (IQR) BSA improved to 0.5% (0.0%; 1.0%) and 0.0% (0.0%; 1.0%) at the 2-month and 1-year visits, respectively. Similar improvements were observed regardless of Fitzpatrick skin type or previous treatment history. No AEs were reported through 1 year of follow-up.
This large case series provides RWE building on tralokinumab clinical trial data and highlights the potential rapid and long-term response in patients with AD irrespective of their Fitzpatrick skin type or treatment history, including patients previously treated with dupilumab.
特应性皮炎（AD）是一种需要长期管理的慢性炎症性疾病。生物疗法已成为AD的全身治疗选择，需要其实践证据（RWE）来为最佳治疗决策提供依据。
进行了一项回顾性单中心病例系列研究，纳入37例AD成人患者，这些患者未曾接受过全身治疗或对既往AD治疗反应不佳，且在2024年5月前接受曲罗芦单抗治疗后约1年进行了一次就诊。收集了患者的人口统计学资料、疾病特征和治疗史。从曲罗芦单抗治疗开始后的2个月随访（定义为1 - 3个月）和1年随访（定义为≥10个月）中提取曲罗芦单抗治疗的结果，包括研究者整体评估（IGA）评分、体表面积（BSA）和不良事件（AE）。
纳入了37例接受曲罗芦单抗治疗约1年或更长时间的患者（中位年龄58.0岁；49%为男性）。基线时，大多数患者（97%[33/34]）患有中度至重度AD（IGA 3或4），中位（四分位间距[IQR]）BSA为10.0%（5.0%；18.8%）；19%（7/37）的患者有生物制剂治疗史，此前曾使用过度普利尤单抗。大多数患者（95%[35/37]）因对先前治疗反应不佳而改用曲罗芦单抗。IGA评分为0或1的患者比例从基线时的0%（0/34）在2个月后增至85%（22/26），在曲罗芦单抗治疗1年后增至93%（28/30）。在2个月和1年随访时，中位（IQR）BSA分别改善至0.5%（0.0%；1.0%）和0.0%（0.0%；1.0%）。无论菲茨帕特里克皮肤类型或既往治疗史如何，均观察到类似的改善。随访1年未报告不良事件。
这个大型病例系列在曲罗芦单抗临床试验数据的基础上提供了实践证据，并强调了AD患者无论其菲茨帕特里克皮肤类型或治疗史如何，包括先前接受过度普利尤单抗治疗的患者，都可能迅速和长期反应。
