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托法替布无类固醇单药治疗重度及治疗抵抗性斑秃、全秃和普秃病例的真实世界研究:一项回顾性分析

A Real-World Study of Steroid-Free Monotherapy with Tofacitinib in Severe and Therapy-Recalcitrant Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Cases: A Retrospective Analysis.

作者信息

Sharath Savitha, Sardana Kabir, Khurana Ananta

机构信息

Department of Dermatology, Venereology and Leprosy, Atal Bihari Vajpayee Institute of Medical Sciences and Research Institute and Dr. Ram Manohar Lohia Hospital, New Delhi, India.

出版信息

Indian Dermatol Online J. 2023 Nov 7;15(1):49-54. doi: 10.4103/idoj.idoj_131_23. eCollection 2024 Jan-Feb.

Abstract

BACKGROUND

Alopecia areata (AA) presents with noncicatricial alopecia and has multifactorial etiology. Janus Kinase inhibitors (JAKibs) with potential efficacy and favorable side-effect profile are the first class of drugs to receive FDA approval in AA.

OBJECTIVES

Our primary objective was to assess the complete response rates to tofacitinib monotherapy in severe and recalcitrant AA, alopecia totalis (AT), and alopecia universalis (AU) patients using the latest percentage change in Severity of alopecia tool (SALT) score. We also aimed to analyze the various systemic agents used by these patients prior to the use of tofacitinib.

MATERIALS AND METHODS

Institutional records of 17 patients with severe or refractory AA, AT, and AU treated with tofacitinib monotherapy were analyzed, retrospectively. The response to tofacitinib therapy was determined after calculating percentage change in SALT score. End of treatment was defined as the dose which resulted in a significant response (complete/near complete response was ≥75% hair regrowth from baseline as determined by SALT score).

RESULTS

Majority of patients had severe AA (SALT ≥ 50) ( = 9/17, 52.94%), while five patients had AT and three had AU. All patients had received either systemic glucocorticoids (GCS), which included oral mini pulse (OMP) ( = 8), intravenous pulse steroids ( = 4), and daily oral GCS ( = 6) or immunosuppressive agents (ISAs) which included cyclosporine ( = 14) followed by methotrexate ( = 6) and azathioprine ( = 6). Mean SALT score prior to starting tofacitinib was 74.23. Mean dose of tofacitinib used was 13.23 mg (10-15 mg) and mean duration of treatment was 9.23 months. Latest percentage change of SALT score ranged from 70.58% to 100%, with an average of 91.47%. Most patients showed complete/near complete response (13/17, 76.47%).

CONCLUSION

Tofacitinib was found to be safe and effective in severe/refractory AA, AU, and AT patients recalcitrant to other treatment modalities in our study. Further studies are needed to assess the effect of these targeted drugs on JAK-STAT expression or tissue cytokines involved in the pathogenesis of AA using immunohistochemistry.

摘要

背景

斑秃(AA)表现为非瘢痕性脱发,病因多因素。Janus激酶抑制剂(JAKibs)具有潜在疗效且副作用良好,是首批获美国食品药品监督管理局(FDA)批准用于斑秃治疗的药物。

目的

我们的主要目的是使用最新的脱发严重程度工具(SALT)评分百分比变化,评估托法替布单药治疗重度及顽固性斑秃、全秃(AT)和普秃(AU)患者的完全缓解率。我们还旨在分析这些患者在使用托法替布之前使用的各种全身用药。

材料和方法

回顾性分析17例接受托法替布单药治疗的重度或难治性斑秃、全秃和普秃患者的机构记录。在计算SALT评分百分比变化后确定对托法替布治疗的反应。治疗结束定义为导致显著反应的剂量(根据SALT评分确定,完全/接近完全缓解为毛发再生从基线起≥75%)。

结果

大多数患者患有重度斑秃(SALT≥50)(n = 9/17,52.94%),而5例患者为全秃,3例患者为普秃。所有患者均接受过全身糖皮质激素(GCS)治疗,其中包括口服小剂量脉冲疗法(OMP)(n = 8)、静脉脉冲类固醇(n = 4)和每日口服糖皮质激素(n = 6),或免疫抑制剂(ISAs),其中包括环孢素(n = 14),其次是甲氨蝶呤(n = 6)和硫唑嘌呤(n = 6)。开始使用托法替布前的平均SALT评分为74.23。使用的托法替布平均剂量为13.23 mg(10 - 15 mg),平均治疗持续时间为9.23个月。SALT评分的最新百分比变化范围为70.58%至100%,平均为91.47%。大多数患者表现出完全/接近完全缓解(13/17,76.47%)。

结论

在我们的研究中,发现托法替布对重度/难治性斑秃、普秃和全秃患者且对其他治疗方式无效的患者安全有效。需要进一步研究以使用免疫组织化学评估这些靶向药物对JAK-STAT表达或参与斑秃发病机制的组织细胞因子的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/815b/10810385/7ba2d0087db9/IDOJ-15-49-g001.jpg

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