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托法替布治疗强直性脊柱炎的疗效与安全性:一项全面的系统评价

Efficacy and Safety of Tofacitinib in the Management of Ankylosing Spondylitis: A Comprehensive Systematic Review.

作者信息

Burhanuddin Mohammad, Chaudhry Sikandar Abbas, Dhami Archana, Iqbal Fatima, Shafiq Sundus, Ullah Sami, Khalid Asma, Hassan Muhammad Wali, Bhatti Muhammad Muaz, Siddique Muhammad Uzair

机构信息

Medicine, Bhaskar Medical College, Hyderabad, IND.

Medicine, King Edward Medical University, Lahore, PAK.

出版信息

Cureus. 2025 Jun 22;17(6):e86556. doi: 10.7759/cureus.86556. eCollection 2025 Jun.

DOI:10.7759/cureus.86556
PMID:40698211
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12283175/
Abstract

Ankylosing spondylitis (AS) is a chronic, immune-mediated inflammatory arthritis that can severely impair the quality of life. Although biologic therapies have significantly advanced disease management, a substantial number of patients continue to experience suboptimal treatment outcomes. This systematic review evaluated the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, in the management of AS. We conducted a comprehensive search across multiple databases for studies published between 2015 and 2025, ultimately including 11 relevant studies (two randomized controlled trials (RCTs) and nine post-hoc or observational analyses). Evidence consistently demonstrated that tofacitinib 5 mg twice daily significantly improved clinical outcomes compared to placebo, with Assessment of Spondyloarthritis International Society (ASAS) response rates of approximately 80% in controlled trials. Tofacitinib demonstrated a rapid onset of action, with improvements in pain occurring within one month and benefits across multiple domains, including fatigue, morning stiffness, and quality of life. Magnetic resonance imaging (MRI) studies confirmed significant reductions in sacroiliac joint and spinal inflammation. The safety profile was consistent with that observed in other indications, with nasopharyngitis and upper respiratory infections being the most common adverse events. Limited cases of herpes zoster were reported, with no documented tuberculosis, malignancies, or thromboembolic events within the study periods. The review supports tofacitinib as an effective option for AS management, with efficacy maintained across various patient subgroups. However, longer-term studies and head-to-head comparisons with biologics are needed to establish its optimal position in treatment algorithms for AS.

摘要

强直性脊柱炎(AS)是一种慢性、免疫介导的炎症性关节炎,会严重损害生活质量。尽管生物疗法在疾病管理方面取得了显著进展,但仍有相当数量的患者治疗效果欠佳。本系统评价评估了口服Janus激酶(JAK)抑制剂托法替布在强直性脊柱炎管理中的疗效和安全性。我们对多个数据库进行了全面检索,以查找2015年至2025年发表的研究,最终纳入了11项相关研究(两项随机对照试验(RCT)和九项事后分析或观察性分析)。证据一致表明,与安慰剂相比,托法替布每日两次、每次5 mg可显著改善临床结局,在对照试验中,国际脊柱关节炎协会(ASAS)反应率约为80%。托法替布起效迅速,用药一个月内疼痛即有所改善,在包括疲劳、晨僵和生活质量在内的多个领域均有获益。磁共振成像(MRI)研究证实骶髂关节和脊柱炎症明显减轻。安全性与在其他适应症中观察到的情况一致,鼻咽炎和上呼吸道感染是最常见的不良事件。报告的带状疱疹病例有限,在研究期间未记录到结核病、恶性肿瘤或血栓栓塞事件。该评价支持托法替布作为强直性脊柱炎管理的有效选择,在各个患者亚组中均维持疗效。然而,需要进行长期研究以及与生物制剂的头对头比较,以确定其在强直性脊柱炎治疗方案中的最佳位置。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6cdd/12283175/702ad71bbae3/cureus-0017-00000086556-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6cdd/12283175/702ad71bbae3/cureus-0017-00000086556-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6cdd/12283175/702ad71bbae3/cureus-0017-00000086556-i01.jpg

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本文引用的文献

1
Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial.托法替布治疗强直性脊柱炎患者疲劳症状的改善:一项3期随机对照试验的分析
Rheumatol Ther. 2025 Feb;12(1):85-98. doi: 10.1007/s40744-024-00727-5. Epub 2024 Dec 13.
2
Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials.托法替布在强直性脊柱炎患者中按基线体重指数分层的疗效/安全性:2/3期试验的事后分析
Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.
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Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status.
托法替布在银屑病关节炎或强直性脊柱炎患者中按吸烟状况划分的疗效与安全性
Rheumatol Ther. 2024 Dec;11(6):1649-1664. doi: 10.1007/s40744-024-00711-z. Epub 2024 Sep 25.
4
Time to improvement of pain, morning stiffness, fatigue, and disease activity in patients with ankylosing spondylitis treated with tofacitinib: a post hoc analysis.接受托法替尼治疗的强直性脊柱炎患者的疼痛、晨僵、疲劳和疾病活动改善时间:一项事后分析。
Arthritis Res Ther. 2024 May 24;26(1):105. doi: 10.1186/s13075-024-03313-w.
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Diagnosis and Treatment of Ankylosing Spondylitis.强直性脊柱炎的诊断与治疗
Cureus. 2024 Jan 19;16(1):e52559. doi: 10.7759/cureus.52559. eCollection 2024 Jan.
6
Do Tofacitinib Generics Exhibit Conventional Synthetic Disease-Modifying Anti-rheumatic Drug and Non-steroidal Anti-inflammatory Drug-Sparing Ability in the Management of Axial Spondyloarthritis?托法替布仿制药在轴性脊柱关节炎管理中是否具有传统合成改善病情抗风湿药及非甾体抗炎药节省效应?
Cureus. 2023 Oct 2;15(10):e46391. doi: 10.7759/cureus.46391. eCollection 2023 Oct.
7
Pain and Inflammation as Mediators of Tofacitinib Treatment Effect on Fatigue in Patients with Ankylosing Spondylitis: A Mediation Analysis.疼痛和炎症作为托法替布治疗强直性脊柱炎患者疲劳的疗效介导因素:一项中介分析
Rheumatol Ther. 2023 Aug;10(4):1073-1087. doi: 10.1007/s40744-023-00570-0. Epub 2023 Jun 23.
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Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial.托法替布可减轻强直性脊柱炎椎体和后外侧结构的脊柱炎症:一项2期试验的结果
Rheumatol Ther. 2023 Aug;10(4):1001-1020. doi: 10.1007/s40744-023-00564-y. Epub 2023 Jun 18.
9
Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial.托法替布治疗活动期强直性脊柱炎患者的疼痛、疲劳、健康相关生活质量和工作生产力的影响:一项 III 期、随机、双盲、安慰剂对照试验的结果。
RMD Open. 2022 Jun;8(2). doi: 10.1136/rmdopen-2022-002253.
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Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.托法替布在减轻类风湿关节炎、银屑病关节炎或强直性脊柱炎患者疼痛方面的疗效。
RMD Open. 2020 Feb;6(1). doi: 10.1136/rmdopen-2019-001042.