在3期Rising Up研究中接受乌帕替尼治疗的日本特应性皮炎患者中的痤疮情况
Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase 3 Rising Up Study.
作者信息
Hayashi Nobukazu, Ikeda Masanori, Liu John, Raymundo Eliza, Liu Yingyi, Sasaki Takuya, Yamasaki Kenshi
机构信息
Department of Dermatology, Toranomon Hospital, Tokyo, Japan.
Okayama University School of Medicine, Okayama, Japan.
出版信息
Dermatol Ther (Heidelb). 2023 Aug;13(8):1817-1830. doi: 10.1007/s13555-023-00961-9. Epub 2023 Jun 25.
INTRODUCTION
Upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is used to treat moderate-to-severe atopic dermatitis (AD). Acne is the most common treatment-emergent adverse event in patients with AD treated with upadacitinib. In this post hoc analysis, we describe the acne events in Japanese patients with AD who received upadacitinib during the Rising Up study.
METHODS
In this phase 3, double-blind, 3-year trial evaluating the safety and efficacy of upadacitinib 15 mg or 30 mg in Japanese patients with moderate-to-severe AD, patients were randomized 1:1:1 to receive upadacitinib 15 mg, 30 mg, or placebo for up to 16 weeks. At week 16, placebo-treated patients were re-randomized 1:1 to receive upadacitinib 15 mg or 30 mg. The incidence, characteristics, and management of treatment-emergent acne events up to the 52-week cutoff date were summarized.
RESULTS
Among 272 patients in this analysis, the incidence of acne was higher in patients receiving upadacitinib compared with patients who received placebo. The rate of acne was higher in patients receiving upadacitinib 30 mg (32.4%) compared with those taking upadacitinib 15 mg (17.3%) during the long-term treatment period. All cases of acne were mild or moderate; no cases led to study drug discontinuation. The mean (range) of acne onset was 135.4 (7-465) days after starting study drug. Most acne occurred on the face; inflammatory papules were the most common morphology. Risk factors for acne included relevant concomitant medications (e.g., corticosteroids) started before acne onset and family and personal history of acne. Acne was generally managed with topical treatments.
CONCLUSION
Mild or moderate acne reported in Japanese patients with AD receiving upadacitinib occurred in a dose-dependent manner and had a variable onset time. Acne was readily managed with topical treatments. Patients and clinicians should be aware of the risk of acne associated with upadacitinib treatment for AD.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03661138.
简介
乌帕替尼是一种口服选择性 Janus 激酶（JAK）抑制剂，用于治疗中度至重度特应性皮炎（AD）。痤疮是接受乌帕替尼治疗的 AD 患者中最常见的治疗中出现的不良事件。在这项事后分析中，我们描述了在“崛起”研究中接受乌帕替尼治疗的日本 AD 患者中的痤疮事件。
方法
在这项 3 期、双盲、为期 3 年的试验中，评估乌帕替尼 15 mg 或 30 mg 对日本中度至重度 AD 患者的安全性和有效性，患者按 1:1:1 随机分组，接受乌帕替尼 15 mg、30 mg 或安慰剂治疗长达 16 周。在第 16 周时，接受安慰剂治疗的患者按 1:1 重新随机分组，接受乌帕替尼 15 mg 或 30 mg。总结了截至第 52 周截止日期时治疗中出现的痤疮事件的发生率、特征和管理情况。
结果
在该分析的 272 名患者中，接受乌帕替尼治疗的患者痤疮发生率高于接受安慰剂治疗的患者。在长期治疗期间，接受 30 mg 乌帕替尼治疗的患者痤疮发生率（32.4%）高于接受 15 mg 乌帕替尼治疗的患者（17.3%）。所有痤疮病例均为轻度或中度；无一例导致研究药物停用。痤疮发病的平均（范围）时间为开始研究药物后 135.4（7 - 465）天。大多数痤疮发生在面部；炎性丘疹是最常见的形态。痤疮的危险因素包括痤疮发作前开始使用的相关伴随药物（如皮质类固醇）以及痤疮家族史和个人史。痤疮一般采用局部治疗。
结论
接受乌帕替尼治疗的日本 AD 患者中报告的轻度或中度痤疮呈剂量依赖性发生，发病时间不一。痤疮很容易通过局部治疗进行管理。患者和临床医生应意识到乌帕替尼治疗 AD 相关的痤疮风险。
试验注册
ClinicalTrials.gov 标识符，NCT03661138。
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