Effectiveness and Safety of Upadacitinib for Adolescents with Atopic Dermatitis in a Real-World Setting.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2024-08-01 Epub Date: 2024-07-16 DOI:10.1007/s40261-024-01382-y

Cataldo Patruno, Giuseppe Lauletta, Elena Pezzolo, Valeria Boccaletti, Mariateresa Rossi, Francesca Caroppo, Anna Belloni Fortina, Filomena Russo, Barbara Cocuroccia, Giacomo Dal Bello, Fabrizio Martora, Francesca di Vico, Maddalena Napolitano

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引用次数: 0

Abstract

Background and objective: The estimated prevalence of atopic dermatitis (AD) among adolescents (12-17 years of age) is about 14.8%. AD compromises sleep quality and may be associated with poor scholastic performance, mood disruptions, low self-esteem, and difficulty in building social relationships. Upadacitinib was recently approved by the European Medicines Agency for the treatment of moderate-to-severe AD in patients aged ≥ 12 years who are candidates for systemic treatment. The aim of this real-world study was to determine the effectiveness in disease control and safety of upadacitinib in adolescents aged 12-17 years with moderate-to-severe AD.

Methods: This is a retrospective study in adolescents with moderate-to-severe AD treated with upadacitinib 15 mg between July 2022 and February 2024 at six Italian dermatological referral centres. The primary endpoint was to analyse the evolution of the response in terms of absolute Eczema Area and Severity Index (EASI) value, as well as the percentage of patients achieving 75% and 90% improvement in EASI (EASI75 and EASI90) from baseline to weeks (W) 4, 16, 24, and 52. Secondary endpoints included the assessment of treatment efficacy in terms of Numerical Rating Scale (NRS) for pruritus (P-NRS) and sleep (S-NRS), Children's Dermatology Life Quality Index (c-DLQI), and safety.

Results: Thirty-six patients [males: 18 (50%)] were evaluated. A statistically significant improvement of EASI was observed at each timepoint, as stated by a mean percentage reduction from baseline of 72.2% at W4, 82.7% at W16, of 86.4% at W24 (n = 34) and of 92.7% at W52 (n = 18) (p < 0.0001). At W4, 21/36 (58.3%) achieved EASI75 and 12/36 (33.3%) EASI90. At W16, 29/36 (80.5%) achieved EASI75 and 19/36 (52.8%) EASI90. At W24, 32/34 (94.1%) reached EASI75 and 24/34 (70.6%) EASI90. Finally, at W52 all the assessed patients (n = 18) maintained EASI75 and 14/18 (77.7%) reached EASI90. Likewise, a statistically significant reduction of c-DLQI, P-NRS and S-NRS was observed at each timepoint.

Conclusion: Our real-world experience seems to confirm the efficacy and safety of upadacitinib for the long-term treatment of moderate-to-severe AD in adolescents.

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乌达帕替尼在真实世界中治疗青少年特应性皮炎的有效性和安全性

背景和目的：据估计，特应性皮炎（AD）在青少年（12-17 岁）中的发病率约为 14.8%。特应性皮炎影响睡眠质量，并可能与学习成绩差、情绪紊乱、自卑和难以建立社会关系有关。欧洲药品管理局最近批准奥帕他替尼用于治疗年龄≥12岁、可接受全身治疗的中重度AD患者。这项真实世界研究旨在确定乌达替尼对12-17岁中重度AD青少年患者疾病控制的有效性和安全性：这是一项回顾性研究，研究对象是2022年7月至2024年2月期间在意大利六家皮肤病转诊中心接受了15毫克奥达帕替尼治疗的中重度AD青少年。主要终点是分析湿疹面积和严重程度指数（EASI）绝对值的反应变化，以及从基线到第4周、第16周、第24周和第52周EASI（EASI75和EASI90）分别改善75%和90%的患者比例。次要终点包括从瘙痒（P-NRS）和睡眠（S-NRS）的数字评定量表（NRS）、儿童皮肤病生活质量指数（c-DLQI）和安全性方面评估疗效：对 36 名患者（男性：18 名，占 50%）进行了评估。在每个时间点均观察到 EASI 有统计学意义的明显改善，与基线相比，W4 的平均百分比下降率为 72.2%，W16 为 82.7%，W24 为 86.4%（n = 34），W52 为 92.7%（n = 18）（p 结论：我们的实际经验似乎证实了这一点：我们的实际经验似乎证实了奥达替尼长期治疗青少年中度至重度AD的有效性和安全性。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.