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巴瑞替尼治疗重度斑秃患者的安全性概况:一项前瞻性研究。

Safety Profile of Baricitinib in Patients With Severe Alopecia Areata: A Prospective Study.

作者信息

di Corteranzo Isotta Giunipero, Bongiovanni Eleonora, Cedirian Stephano, Starace Michela, Piraccini Bianca Maria, Mastorino Luca, Quaglino Pietro, Ribero Simone, Gallo Giuseppe

机构信息

Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy.

Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

出版信息

Int J Dermatol. 2025 Jul;64(7):1242-1245. doi: 10.1111/ijd.17732. Epub 2025 Mar 21.

DOI:10.1111/ijd.17732
PMID:40116151
Abstract

INTRODUCTION

In adults, baricitinib, a Janus kinase (JAK)1/JAK2 inhibitor, is the first globally approved treatment for severe alopecia areata (AA). Its efficacy and safety were established in phase III trials, but real-life evidence remains limited.

OBJECTIVE

Our aim was to evaluate the real-life safety profile of baricitinib over 48 weeks in a clinical setting.

METHODS

A prospective observational study was conducted on 87 adult patients with severe AA at the University Hospital of Turin. Patients were treated with baricitinib at doses of 2 or 4 mg daily and were evaluated at baseline, 12, 24, 36, and 48 weeks. Adverse events (AEs) were carefully monitored, and disease severity was measured using the Severity of Alopecia Tool (SALT) score.

RESULTS

The cohort consisted of 71% females, with a mean age of 42 years and a mean baseline SALT score of 76.9. Baricitinib was generally well tolerated, with 20% of patients reporting AEs. The most common AEs were hypercholesterolemia (17%), hypertriglyceridemia (9.2%), and upper respiratory tract infections (5%). Two patients discontinued treatment due to neutropenia and recurrent infections. Most AEs were mild and manageable.

CONCLUSION

Baricitinib shows a favorable safety profile in real-life clinical settings, aligning with findings from controlled clinical trials. The results support its use in routine clinical practice, though larger prospective studies are needed for further confirmation.

摘要

引言

在成人中,巴瑞替尼,一种 Janus 激酶(JAK)1/JAK2 抑制剂,是全球首个获批用于治疗重度斑秃(AA)的药物。其疗效和安全性已在 III 期试验中得到证实,但实际应用中的证据仍然有限。

目的

我们的目的是在临床环境中评估巴瑞替尼在 48 周内的实际安全性。

方法

在都灵大学医院对 87 例重度 AA 成年患者进行了一项前瞻性观察研究。患者接受每日 2 毫克或 4 毫克剂量的巴瑞替尼治疗,并在基线、12 周、24 周、36 周和 48 周时进行评估。仔细监测不良事件(AE),并使用脱发严重程度工具(SALT)评分来衡量疾病严重程度。

结果

该队列中 71%为女性,平均年龄 42 岁,基线 SALT 评分平均为 76.9。巴瑞替尼总体耐受性良好,20%的患者报告了 AE。最常见的 AE 是高胆固醇血症(17%)、高甘油三酯血症(9.2%)和上呼吸道感染(5%)。两名患者因中性粒细胞减少和反复感染而停药。大多数 AE 为轻度且易于处理。

结论

巴瑞替尼在实际临床环境中显示出良好的安全性,与对照临床试验的结果一致。这些结果支持其在常规临床实践中的应用,不过需要更大规模的前瞻性研究来进一步证实。

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引用本文的文献

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Dermatol Ther (Heidelb). 2025 Jul 7. doi: 10.1007/s13555-025-01468-1.