Weidinger Stephan, Schadeck Tobias, Jacobs Felix, Weyergraf Ansgar, Mortazawi Dariusch, Hagemann Tobias, Abousamra Fatima, Mosch Thomas, Fritz Bjoern, Lauffer Felix
Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Rosalind-Franklin-Straße 7, 24105, Kiel, Germany.
Dermatology Practice, Bogen, Germany.
Dermatol Ther (Heidelb). 2025 Apr;15(4):919-931. doi: 10.1007/s13555-025-01373-7. Epub 2025 Mar 15.
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.
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.
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.
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.
ClinicalTrials.gov, NCT05139836.
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。
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。
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。
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。
ClinicalTrials.gov，NCT05139836。
