Successful Achievement of Demanding Outcomes in Upadacitinib-Treated Atopic Dermatitis Patients: A Real-World, 96-Week Single-Centre Study.

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI:10.1007/s13555-024-01334-6

Stamatios Gregoriou, Ioannis-Alexios Koumprentziotis, Ileana Afroditi Kleidona, Michail Bakakis, Eleni Hatzidimitriou, Theodora Douvali, Aikaterini Tsiogka, Styliani Mastraftsi, Aristeidis Vaiopoulos, Alexander Stratigos

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Abstract

Introduction: Results from randomized controlled trials of upadacitinib, a Janus kinase (JAK) inhibitor, have led to its approval for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥ 12 years. The aim of this study was to report the effectiveness and safety of upadacitinib in real-world settings over a period of 96 weeks.

Methods: This retrospective study included all patients treated with upadacitinib at our centre between April 2022 and September 2024. Clinical and patient-reported outcomes were recorded and assessed at each follow-up visit and included the eczema area severity index (EASI), investigator global assessment (IGA), scoring atopic dermatitis (SCORAD), dermatology life quality index (DLQI) and the worst pruritus numerical scale score (WP-NRS). All drug-related adverse events (AEs) were documented.

Results: In total, 36 patients (44.4% female) were retrospectively included. After 4 weeks of treatment, the mean EASI was reduced from 29.97 to 3.72 with 83.3/52.8/19.4% achieving EASI75/90/100 respectively. Similar reductions were observed in the DLQI, which was reduced from 20.78 to 2.92, and in the WP-NRS, from 7.78 to 1.31. Further improvements were observed at week 16, with a mean EASI of 0.75 and 96.4% of the patients achieving EASI75 and EASI90. At week 48 of treatment, EASI75/90/100 were achieved by 100/93.8/81.3% along with a mean DLQI and pruritus NRS of 0.81. All nine patients that reached the 72- and 96-week timepoints had clear skin with no pruritus. Six (16.7%) patients experienced AEs with four of them discontinuing medication; no patient discontinued because of upadacitinib inefficacy.

Conclusion: This long-term real-world study of patients with moderate-to-severe AD receiving upadacitinib demonstrated that treatment success (EASI75/90/100) can be achieved in a high proportion of patients by week 16 and can be maintained for up to 96 weeks along with substantial improvements in pruritus and quality of life.

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upadacitinib治疗特应性皮炎患者的疗效：一项真实世界96周单中心研究

来自Janus激酶（JAK）抑制剂upadacitinib的随机对照试验结果表明，upadacitinib被批准用于治疗年龄≥12岁的中重度特应性皮炎（AD）患者。本研究的目的是报告upadacitinib在96周的现实环境中的有效性和安全性。方法：这项回顾性研究纳入了2022年4月至2024年9月期间在我们中心接受upadacitinib治疗的所有患者。在每次随访时记录和评估临床和患者报告的结果，包括湿疹区域严重程度指数（EASI）、研究者总体评估（IGA）、特应性皮炎评分（SCORAD）、皮肤病生活质量指数（DLQI）和最严重瘙痒数值量表评分（WP-NRS）。记录了所有药物相关不良事件（ae）。结果：回顾性分析36例患者，其中女性44.4%。治疗4周后，平均EASI由29.97降至3.72，分别有83.3/52.8/19.4%达到EASI75/90/100。DLQI也有类似的下降，从20.78降至2.92，WP-NRS从7.78降至1.31。在第16周观察到进一步的改善，平均EASI为0.75,96.4%的患者达到EASI75和EASI90。治疗第48周，EASI75/90/100达到100/93.8/81.3%，平均DLQI和瘙痒NRS为0.81。所有达到72周和96周时间点的9名患者都有干净的皮肤，没有瘙痒。6例（16.7%）患者出现不良反应，其中4例停药；没有患者因为upadacitinib无效而停药。结论：这项对接受upadacitinib治疗的中重度AD患者的长期现实世界研究表明，在第16周时，高比例的患者可以获得治疗成功（EASI75/90/100），并且可以维持长达96周，同时瘙痒和生活质量也有了实质性的改善。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.