乌帕替尼在中重度特应性皮炎中早期实现高治疗目标：来自观察性UP-TAINED研究的真实世界证据
Early Achievement of High Treatment Targets in Moderate-to-Severe Atopic Dermatitis with Upadacitinib: Real-World Evidence from the Observational UP-TAINED Study.
作者信息
Weidinger Stephan, Schadeck Tobias, Jacobs Felix, Weyergraf Ansgar, Mortazawi Dariusch, Hagemann Tobias, Abousamra Fatima, Mosch Thomas, Fritz Bjoern, Lauffer Felix
机构信息
Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Rosalind-Franklin-Straße 7, 24105, Kiel, Germany.
Dermatology Practice, Bogen, Germany.
出版信息
Dermatol Ther (Heidelb). 2025 Apr;15(4):919-931. doi: 10.1007/s13555-025-01373-7. Epub 2025 Mar 15.
INTRODUCTION
Phase 3 clinical trials have demonstrated robust efficacy and favorable safety of upadacitinib for the treatment of atopic dermatitis (AD). However, real-world data are still sparse. The objectives of this study were to assess the effectiveness and safety of real-world treatment with upadacitinib in patients with moderate-to-severe AD.
METHODS
UP-TAINED is an ongoing German prospective, multicenter, observational study in adolescents and adults with moderate-to-severe AD treated with upadacitinib 15 or 30 mg once daily, according to local labeling. Effectiveness (primary endpoint; measured with the Atopic Dermatitis Control Tool [ADCT]) and safety are assessed over 2 years. Reported here are 1-year results from an interim analysis.
RESULTS
Data on 351 patients were included in the effectiveness analysis. At 12 weeks, 71.0% of patients had achieved disease control (ADCT total score < 7); at 1 year, this rate was 70.9%. An Eczema Area and Severity Index (EASI) ≤ 3 was achieved by 60.6% of patients after 4 weeks and 68.1% after 1 year of upadacitinib treatment. Of 186 patients with moderate-to-severe facial eczema at baseline and 142 patients with moderate-to-severe hand eczema at baseline, 60.8% (101/166) and 63.8% (83/101) achieved clear or almost clear skin in those respective body regions after 4 weeks of upadacitinib treatment. Of the 380 patients included in the safety analysis, 163 patients reported 426 adverse events (AEs), most classified as mild (59.7%) or moderate (34.6%). The most common AEs were (worsening of) AD, acne, and COVID-19. No major cardiovascular AEs, venous thromboembolism, or malignancies were reported.
CONCLUSIONS
Upadacitinib was well tolerated, and the majority of patients with moderate-to- severe AD receiving upadacitinib in real-world clinical practice achieved stringent treatment goals with early and up to 1-year disease control attained, particularly in difficult-to-treat areas such as hand and face.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT05139836.
引言
3期临床试验已证明乌帕替尼治疗特应性皮炎（AD）具有强大的疗效和良好的安全性。然而，真实世界的数据仍然稀少。本研究的目的是评估乌帕替尼在中度至重度AD患者中的真实世界治疗效果和安全性。
方法
UP-TAINED是一项正在进行的德国前瞻性、多中心、观察性研究，纳入了中度至重度AD的青少年和成人患者，根据当地标签，每日一次服用15或30毫克乌帕替尼。在2年时间内评估疗效（主要终点；用特应性皮炎控制工具[ADCT]测量）和安全性。本文报告的是中期分析的1年结果。
结果
351例患者的数据纳入疗效分析。在12周时，71.0%的患者实现了疾病控制（ADCT总分<7）；在1年时，这一比例为70.9%。乌帕替尼治疗4周后，60.6%的患者湿疹面积和严重程度指数（EASI）≤3，治疗1年后这一比例为68.1%。在基线时患有中度至重度面部湿疹的186例患者和基线时患有中度至重度手部湿疹的142例患者中，乌帕替尼治疗4周后，分别有60.8%（101/166）和63.8%（83/101）的患者在相应身体部位实现了皮肤清除或几乎清除。在纳入安全性分析的380例患者中，163例患者报告了426起不良事件（AE），大多数分类为轻度（59.7%）或中度（34.6%）。最常见的不良事件是AD（加重）、痤疮和新型冠状病毒肺炎。未报告重大心血管不良事件、静脉血栓栓塞或恶性肿瘤。
结论
乌帕替尼耐受性良好，在真实世界临床实践中，大多数接受乌帕替尼治疗的中度至重度AD患者实现了严格的治疗目标，早期以及长达1年的疾病得到控制，尤其是在手部和面部等难治性部位。
临床试验注册
ClinicalTrials.gov，NCT05139836。
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