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乌帕替尼在中重度特应性皮炎停药后重新治疗的有效性和安全性:一项回顾性研究

Effectiveness and safety of upadacitinib retreatment after withdrawal in moderate-to-severe atopic dermatitis: a retrospective study.

作者信息

Hagino Teppei, Saeki Hidehisa, Fujimoto Eita, Kanda Naoko

机构信息

Department of Dermatology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.

Department of Dermatology, Nippon Medical School, Tokyo, Japan.

出版信息

Clin Exp Dermatol. 2025 Mar 26;50(4):770-778. doi: 10.1093/ced/llae410.

Abstract

BACKGROUND

Upadacitinib, a Janus kinase 1 (JAK1) inhibitor, is effective for moderate-to-severe atopic dermatitis (AD). Upadacitinib treatment may be discontinued in some patients; however, the effectiveness and safety of retreatment after its withdrawal have not been examined in detail in real-world practice.

OBJECTIVES

To evaluate the effectiveness and safety of upadacitinib retreatment after withdrawal in real-world clinical practice for Japanese patients with AD.

METHODS

This retrospective study included 62 Japanese patients with moderate-to-severe AD treated with upadacitinib 15 mg (n = 38) or 30 mg (n = 24). Effectiveness was assessed using the Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Rating Scale (PP-NRS) before treatment (baseline), at timepoints of discontinuation, at retreatment, and at week 12 after retreatment with upadacitinib. Safety was evaluated through the incidence of treatment-emergent adverse events (TEAEs).

RESULTS

EASI and PP-NRS scores significantly decreased at week 12 after upadacitinib retreatment compared with baseline in both the 15-mg and 30-mg groups (P = 0.01 for EASI and PP-NRS in both groups). At week 12 after retreatment, achievement rates of at least a 75%, 90% or 100% reduction in EASI from baseline (EASI 75, EASI 90 or EASI 100, respectively) were 84%, 57% and 19% in the 15-mg group, and 87%, 57% and 17% in the 30-mg group, respectively. TEAEs were mild or moderate, and no serious AEs or deaths were reported.

CONCLUSIONS

Retreatment with upadacitinib after withdrawal effectively improved clinical signs and pruritus in patients with AD, with a manageable safety profile, supporting its use for long-term management of AD.

摘要

背景

乌帕替尼是一种 Janus 激酶 1(JAK1)抑制剂,对中重度特应性皮炎(AD)有效。部分患者可能会停用乌帕替尼治疗;然而,停药后再次治疗的有效性和安全性在实际临床实践中尚未得到详细研究。

目的

评估在日本 AD 患者的实际临床实践中,停药后再次使用乌帕替尼治疗的有效性和安全性。

方法

这项回顾性研究纳入了 62 例接受 15mg(n = 38)或 30mg(n = 24)乌帕替尼治疗的日本中重度 AD 患者。在治疗前(基线)、停药时间点、再次治疗时以及再次使用乌帕替尼治疗 12 周时,使用湿疹面积和严重程度指数(EASI)和瘙痒峰值数字评定量表(PP-NRS)评估有效性。通过治疗中出现的不良事件(TEAE)发生率评估安全性。

结果

与基线相比,15mg 和 30mg 组在再次使用乌帕替尼治疗 12 周时 EASI 和 PP-NRS 评分均显著降低(两组 EASI 和 PP-NRS 的 P 值均为 0.01)。再次治疗 12 周时,15mg 组 EASI 较基线至少降低 7

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