Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, Seongbuk-gu, 02841, Seoul, Korea (Republic of).
Z Rheumatol. 2022 Feb;81(1):71-76. doi: 10.1007/s00393-020-00948-3. Epub 2020 Dec 18.
In this study, we aimed to assess the safety and efficacy of Janus kinase (JAK) inhibitors in patients with ankylosing spondylitis (AS).
We conducted a Bayesian network meta-analysis using direct and indirect data from randomized controlled trials (RCTs), and examined the safety and efficacy of JAK inhibitors in active AS patients exhibiting inadequate response or intolerance to two or more non-steroidal anti-inflammatory drugs (NSAIDs).
RCTs included a total of 406 patients (203 experimental subjects and 203 controls) from three studies on upadacitinib, filgotinib, and tofacitinib. Assessment of SpondyloArthritis International Society 20% improvement (ASAS20), ASAS40, and ASAS5/6 responses were significantly higher in the JAK inhibitor group than in the placebo group. Other efficacy outcomes, such as ASAS partial remission, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), Ankylosing Spondylitis Disease Activity Score (ASDAS), Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) scores, and Bath Ankylosing Spondylitis Functional Index (BASFI) were also significantly higher in the JAK inhibitor group compared to the placebo group. The JAK inhibitors significantly improved disease activity (ASAS partial remission, BASDAI50, ASDAS), function (BASFI), and MRI outcomes (SPARCC MRI spine). However, the incidence of adverse events (AEs) and serious adverse events (SAEs), and the rate of withdrawal attributed to AEs did not differ between the JAK inhibitor and placebo groups.
JAK inhibitors were effective in active AS patients exhibiting an inadequate response or intolerance to two or more NSAIDs, without the risk of SAEs; this suggests that based on our data, studies are warranted to further investigate the use of JAK inhibitors for treating AS.
本研究旨在评估 Janus 激酶（JAK）抑制剂在强直性脊柱炎（AS）患者中的安全性和疗效。
我们采用直接和间接来自随机对照试验（RCT）的数据进行贝叶斯网络荟萃分析，并检查了 JAK 抑制剂在对两种或两种以上非甾体抗炎药（NSAIDs）反应不足或不耐受的活动性 AS 患者中的安全性和疗效。
共纳入三项关于乌帕替尼、氟可替尼和托法替尼的 RCT，总计纳入 406 名患者（203 名试验组，203 名对照组）。JAK 抑制剂组的 SpA 国际协会 20%改善（ASAS20）、ASAS40 和 ASAS5/6 缓解率显著高于安慰剂组。其他疗效结局，如 ASAS 部分缓解、Bath 强直性脊柱炎疾病活动指数（BASDAI50）、强直性脊柱炎疾病活动评分（ASDAS）、加拿大脊柱关节炎研究协会（SPARCC）磁共振成像（MRI）评分和 Bath 强直性脊柱炎功能指数（BASFI）在 JAK 抑制剂组也显著高于安慰剂组。JAK 抑制剂显著改善疾病活动度（ASAS 部分缓解、BASDAI50、ASDAS）、功能（BASFI）和 MRI 结局（SPARCC MRI 脊柱）。然而，JAK 抑制剂组和安慰剂组的不良事件（AE）发生率和严重不良事件（SAE）发生率以及因 AE 退出率无差异。
在对两种或两种以上 NSAIDs 反应不足或不耐受的活动性 AS 患者中，JAK 抑制剂有效且无 SAE 风险；这表明，根据我们的数据，有必要开展研究进一步探讨 JAK 抑制剂治疗 AS 的应用。
