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Introduction <p>Phase&#xa0;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.</p> Methods <p>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&#xa0;mg once daily, according to local labeling. Effectiveness (primary endpoint; measured with the Atopic Dermatitis Control Tool [ADCT]) and safety are assessed over 2&#xa0;years. Reported here are 1-year results from an interim analysis.</p> Results <p>Data on 351 patients were included in the effectiveness analysis. At 12&#xa0;weeks, 71.0% of patients had achieved disease control (ADCT total score &lt; 7); at 1&#xa0;year, this rate was 70.9%. An Eczema Area and Severity Index (EASI) ≤ 3 was achieved by 60.6% of patients after 4&#xa0;weeks and 68.1% after 1&#xa0;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&#xa0;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.</p> Conclusions <p>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.</p> Clinical Trial Registration <p>ClinicalTrials.gov, NCT05139836.</p>

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Early Achievement of High Treatment Targets in Moderate-to-Severe Atopic Dermatitis with Upadacitinib: Real-World Evidence from the Observational UP-TAINED Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月15日

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  • Stephan Weidinger,
  • Tobias Schadeck,
  • Felix Jacobs,
  • Ansgar Weyergraf,
  • Dariusch Mortazawi,
  • Tobias Hagemann,
  • Fatima Abousamra,
  • Thomas Mosch,
  • Bjoern Fritz,
  • Felix Lauffer

摘要

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.