Efficacy and safety of upadacitinib, a selective JAK-1 inhibitor in treatment of ankylosing spondylitis: a meta-analysis

Abstract

Objective: To systemically evaluate efficacy and safety of upadacitinib (UPA), a selective inhibitor of Janus kinase 1 (JAK1) in treatment of ankylosing spondylitis (AS). Methods: PubMed, Embase, Elsevier, Springer, Google Scholar, Cochrane Library, China national knowledge infrastructure (CNKI), and other databases were used to retrieve literatures of randomized controlled trials (RCTs) of UPA treating AS until February 2024. After that, the data were extracted and the Revman 5.4 software was used to conduct a meta-analysis. Results: A total of 6 articles and 1653 patients (920 in an UPA group (15 mg, q.d) and 733 in a placebo group) were selected in this study. Respectively, the UPA treatment significantly increased numbers of the AS patients with 40%, 20%, and partial remission (PR) improvement in assessment of spondylo arthritis international society (ASAS) (ASAS 40: 95%CI: 2.41 - 4.3, p < 0.00001; ASAS 20: 95%CI: 2.12 - 3.62, p< 0.00001; ASAS PR: 95%CI: 2.81 - 7.48, p < 0.00001), Bath ankylosing spondylitis disease activity index (BASDAI50) (95%CI: 2.28 ～ 4.10, p < 0.00001), quality of life (95%CI: 2.06 ～ 3.17, p < 0.00001), AS disease activity score low disease activity (ASDAS LDA) (95%CI: 3.07～9.96, p < 0.00001), ASDAS inactive disease (ID) (95%CI: 2.03 ～ 17.22, p = 0.001), short-form 36 physical component summary (SF-36PCS) (95%CI: 1.53 ～2.81, p < 0.00001), and markedly reduced ASDAS C-reactive protein (CRP) (95%CI: -1.22 ～ -0.42, p < 0.0001), total back pain score (95%CI: -2.01 ～ -0.51, p = 0.001), nighttime back pain score (95%CI: -1.96 ～ -0.54, p = 0.0006), spondylo arthritis research consortium of Canada magnetic resonance imaging (SPARCC MRI) spine score (95%CI: -7.78 - -3.50, p < 0.00001) and SPARCC MRI sacroiliac joint score (95%CI: -5.99 - -3.09, p < 0.00001), Bath ankylosing spondylitis function index (BASFI) score (95%CI: -1.45 ～ -0.81, p < 0.00001), Maastricht ankylosing spondylitis enthesitis score (MASES) (95%CI: -2.34～-0.35, p = 0.008). Except for neutropenia (95%CI: 1.25 ～ 15.60, p = 0.02), no other obvious adverse effects (AEs) were found after the UPA treatment. Conclusions: UPA exerts a significant therapeutic effect in the patients with AS, and it has relative higher safety.