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巴瑞替尼治疗重度斑秃:一项为期52周的多中心回顾性真实世界研究结果

Baricitinib for the treatment of severe alopecia areata: results from a 52-week multicenter retrospective real-world study.

作者信息

Vignoli Carlo A, Gargiulo Luigi, Ibba Luciano, Balato Anna, Barbareschi Mauro, Barruscotti Stefania, Bazzacco Giulia, Bellinato Francesco, Bianchi Vittoria G, Boccaletti Valeria, Caposiena Caro Raffaele D, Ferrucci Silvia M, Fraghì Alessandro, Fulgione Elisabetta, Gallo Giuseppe, Gisondi Paolo, Giunipero di Corteranzo Isotta, Malagoli Piergiorgio, Marzano Angelo V, Mercuri Santo R, Orsini Diego, Quaglino Pietro, Ribero Simone, Costanzo Antonio, Narcisi Alessandra

机构信息

Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.

Department of Biomedical Sciences, Humanitas University, Milan, Italy.

出版信息

J Dermatolog Treat. 2025 Dec;36(1):2444494. doi: 10.1080/09546634.2024.2444494. Epub 2025 Jan 6.

Abstract

Baricitinib, a JAK 1/2 inhibitor, is approved for treating severe alopecia areata (AA). This study aimed to evaluate the long-term effectiveness and safety of baricitinib in a real-world setting over 52 weeks. This multicenter retrospective study included 96 adult patients diagnosed with severe AA from 11 Italian Dermatology Units. All patients received 4 mg of baricitinib daily. Effectiveness was assessed using the Severity of Alopecia Tool (SALT) score, with the primary endpoint defined as achieving a SALT score ≤ 20 at week 52. Secondary endpoints included achieving a Clinician-Reported Outcome (ClinRO) score of 0 or 1 for eyebrow (ClinRO EB) and eyelash hair loss (ClinRO EL), with a ≥ 2-point improvement from baseline. After 52 weeks, 61.5% of patients achieved a SALT score ≤ 20. Additionally, 67.6% and 69.7% of patients attained ClinRO EB and ClinRO EL scores of 0 or 1, respectively, with a ≥ 2-point improvement. No significant adverse safety events were reported during the study. The study confirms the long-term effectiveness and safety of baricitinib for severe AA in a real-world setting. These findings align with clinical trial results and reinforce baricitinib's role as a viable treatment option for severe AA.

摘要

巴瑞替尼是一种JAK 1/2抑制剂,已被批准用于治疗重度斑秃(AA)。本研究旨在评估巴瑞替尼在现实环境中52周的长期有效性和安全性。这项多中心回顾性研究纳入了来自11个意大利皮肤科单位的96例被诊断为重度AA的成年患者。所有患者每天接受4毫克巴瑞替尼治疗。使用脱发严重程度工具(SALT)评分评估有效性,主要终点定义为在第52周时SALT评分≤20。次要终点包括眉部(ClinRO EB)和睫毛脱发(ClinRO EL)的临床医生报告结局(ClinRO)评分为0或1,且较基线改善≥2分。52周后,61.5%的患者SALT评分≤20。此外,分别有67.6%和69.7%的患者ClinRO EB和ClinRO EL评分达到0或1,且改善≥2分。研究期间未报告重大不良安全事件。该研究证实了巴瑞替尼在现实环境中治疗重度AA的长期有效性和安全性。这些发现与临床试验结果一致,并强化了巴瑞替尼作为重度AA可行治疗选择的作用。

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