背景:Upadacitinib,一种选择性JAK1抑制剂,在治疗中轴性关节炎(AxSpA)方面已显示出有希望的结果。AxSpA管理仍然具有挑战性,因为关于upadacitinib对axSpA患者的潜在影响存在知识空白。探索新的治疗方案至关重要。因此,我们进行了这项系统评价和荟萃分析,以总结和综合从现有随机对照试验(RCT)中收集的有关upadacitinib治疗axSpA患者的疗效和安全性的结果.
方法:通过PubMed对Medline进行系统的文献检索,WebofScience,Scopus,EBSCO,CochraneCentral于2023年10月进行。选择了相关的随机对照试验,并使用RevMan5.4软件对其数据进行提取和分析。主要结果为关节炎国际协会(ASAS)20,ASAS40,SPARCCMRI骶髂关节评估,和巴斯强直性脊柱炎疾病活动指数(BASDAI)50。
结果:本研究纳入了三项随机对照试验,共920名参与者。Upadacitinib显示ASAS40反应的显着改善,ASAS20响应,BASDAI50回应,和SPARCCMRI骶髂关节从基线的变化相比安慰剂在14周的持续时间(RR2.19,95%CI(1.79至2.68),P<0.00001),(RR1.62,95%CI[1.42至1.84),P<0.00001),(RR2.16,95%CI(1.75至2.67),P<0.00001),和(MD-3.32分,95%CI(-3.96至-2.68),P<0.00001)。然而,在ASAS40RR2.19vs.的52周后,这种疗效下降1.02,ASAS20RR1.62与0.98,BASDAI50RR2.16vs.1.05,ASAS部分缓解RR3.82与1.07.
结论:Upadacitinib15mg治疗AxSpA的疗效令人满意,与安慰剂相比,安全性没有差异。
BACKGROUND: Upadacitinib, a selective JAK1 inhibitor, has demonstrated promising results in the treatment of axial Spondyloarthritis (AxSpA). AxSpA management remains challenging since there is a gap in knowledge regarding the potential effect of upadacitinib in axSpA patients. Exploring novel therapeutic options is crucial. Therefore, we performed this systematic review and meta-analysis to summarize and synthesize results collected from available randomized-- controlled trials (RCTs) about the efficacy and safety of upadacitinib for patients with axSpA.
METHODS: A systematic literature search of Medline via PubMed, Web of Science, Scopus, EBSCO, and Cochrane Central was conducted in October 2023. Relevant RCTs were selected, and their data were extracted and analyzed using the RevMan 5.4 software. The main outcomes were assessment in Spondylarthritis International Society (ASAS) 20, ASAS40, SPARCC MRI sacroiliac joint, and Bath Ankylosing Spondylitis disease activity index (BASDAI) 50.
RESULTS: Three RCTs with a total of 920 participants were included in this study. Upadacitinib showed significant improvement in the ASAS40 response, ASAS20 response, BASDAI50 response, and SPARCC MRI Sacroiliac Joint change from baseline compared to placebo at 14-week duration (RR 2.19, 95% CI (1.79 to 2.68), P < 0.00001), (RR 1.62, 95% CI [1.42 to 1.84), P < 0.00001), (RR 2.16, 95% CI (1.75 to 2.67), P < 0.00001), and (MD -3.32 points, 95% CI (-3.96 to -2.68), P < 0.00001) respectively. However, this efficacy decreased after the 52-week duration in terms of ASAS40 RR 2.19 vs. 1.02, ASAS20 RR 1.62 vs. 0.98, BASDAI 50 RR 2.16 vs. 1.05, and ASAS Partial Remission RR 3.82 vs. 1.07.
CONCLUSIONS: Upadacitinib 15 mg showed satisfactory and promising efficacy in the treatment of AxSpA, with no difference in safety profile compared to the placebo.