巴利昔尼的实际有效性和安全性,包括其对日本成年特应性皮炎患者的生物标志物和实验室数据的影响:一项单中心回顾性研究

A. Watanabe, M. Kamata, Yoshiki Okada, Shoya Suzuki, Makoto Ito, I. Mizukawa, H. Uchida, S. Egawa, Chika Chijiwa, Azusa Hiura, S. Fukaya, Kotaro Hayashi, A. Fukuyasu, Takamitsu Tanaka, T. Ishikawa, Y. Tada
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引用次数: 0

摘要

巴利昔尼在特应性皮炎(AD)的临床试验中显示出了疗效和可耐受的安全性;然而,真实世界的数据却很有限。我们研究了巴利昔尼的有效性和安全性,以及本部门接受巴利昔尼治疗的特应性皮炎患者的实验室数据。我们还评估了应答者和非应答者的基线临床严重程度。我们纳入了 2021 年 1 月至 2023 年 2 月期间在本部门接受巴利昔尼治疗的所有成人 AD 患者。我们分析了 30 名日本 AD 患者的数据。客观严重程度评分和患者报告结果在1个月和3个月时均有改善,但1个月时的受影响体表面积除外。湿疹面积和严重程度指数改善50%的患者比例分别为:1个月时30.0%(9/30),3个月时53.3%(16/30)。AD 生物标志物无明显变化。在基线临床严重程度方面,未观察到应答者与非应答者之间有明显差异。除了 3 个月时血清肌酸磷酸激酶水平升高外,化验结果无明显变化。观察到一例带状疱疹和一例眼部疱疹。巴利昔尼显示出温和的有效性和良好的安全性,包括实验室结果。生物标志物不能反映临床改善情况。需要进一步研究以确定应答者的特征。
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Real-world effectiveness and safety of baricitinib including its effect on biomarkers and laboratory data in Japanese adult patients with atopic dermatitis: a single-center retrospective study
Baricitinib demonstrated efficacy and tolerable safety in clinical trials for atopic dermatitis (AD); however, real-world data are limited. We examined effectiveness and safety of baricitinib, and laboratory data in AD patients treated with baricitinib in our department. We also evaluated baseline clinical severity in responders and non-responders. All adult AD patients treated with baricitinib in our department between January 2021 and February 2023 were included. Data on 30 Japanese AD patients were analyzed. Objective severity scores and patient-reported outcomes improved at one and 3 months, except for the affected body surface area at 1 month. The proportions of patients who achieved eczema area and severity index-50% improvement were 30.0% (9/30) at 1 month and 53.3% (16/30) at 3 months. There were no significant changes in AD biomarkers. No significant difference was observed in baseline clinical severity between responders and non-responders. No significant changes were observed in laboratory results except for increased serum creatine phosphokinase levels at 3 months. One case of herpes zoster and one case of ocular herpes were observed. Baricitinib showed mild effectiveness and favorable safety including laboratory findings. Biomarkers did not reflect clinical improvement. Further study is needed to identify characteristics of responders.
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