Medical Research Group of Egypt, Negida Academy, Arlington, MA, USA.
Faculty of Medicine, Benha University, Benha, Egypt.
Clin Rheumatol. 2024 Feb;43(2):579-589. doi: 10.1007/s10067-023-06731-4. Epub 2023 Aug 15.
Baricitinib is a selective Janus kinase inhibitor that has recently been approved for treating certain autoimmune disorders. This meta-analysis pooled the conflicting results from all published randomized controlled trials (RCTs) about the efficacy and safety of baricitinib in patients with systemic lupus erythematosus (SLE). We systemically searched four electronic databases. RCTs comparing baricitinib versus placebo were included. Our outcomes were pooled as the risk ratio (RR) in the random effects model. Our primary outcome was the proportion of patients who achieved a SLE Responder Index-4 (SRI-4) response. A total of three RCTs, comprising 1849 patients, were included. Baricitinib 4 mg was associated with a significantly higher proportion of patients who attained SRI-4 response at week 24 (RR = 1.19, 95% CI [1.05, 1.35], P < 0.01). However, this did not reach statistical significance with baricitinib 4 mg at week 52 and baricitinib 2 mg at both week 24 and week 52 (RR = 1.13, 95% CI [0.96, 1.34], P = 0.15; RR = 1.09, 95% CI [0.96, 1.24], P = 0.20; RR = 1.05, 95% CI [0.92, 1.19], P = 0.50, respectively). The risk for serious infections was higher in the baricitinib 4 mg group (RR = 2.23, 95% CI [1.13, 4.37], P = 0.02). Baricitinib 2 mg did not show any clinical benefit. In contrast, baricitinib 4 mg might have the potential to reduce SLE disease activity; however, further research is required to evaluate its long-term efficacy. Until higher-quality evidence is developed, the benefits and risks of baricitinib should be considered before initiating its therapy. Key Points • Baricitinib is a selective Janus kinase inhibitor that has recently been approved for treating certain autoimmune disorders; however, its efficacy in patients with systemic lupus erythematosus (SLE) is still inconclusive. • In our meta-analysis, baricitinib 2 mg did not show any clinical benefit. In contrast, baricitinib 4 mg significantly reduced SLE activity in terms of SRI-4 response at week 24. However, this did not reach statistical significance at week 52. • Further studies are required to investigate the long-term efficacy of baricitinib 4 mg in patients with SLE.
巴利昔替尼是一种选择性的 Janus 激酶抑制剂，最近已被批准用于治疗某些自身免疫性疾病。这项荟萃分析汇总了所有已发表的随机对照试验（RCT）中关于巴利昔替尼治疗系统性红斑狼疮（SLE）患者的疗效和安全性的相互矛盾的结果。我们系统地检索了四个电子数据库。纳入了比较巴利昔替尼与安慰剂的 RCT。我们的结局以随机效应模型中的风险比（RR）进行汇总。我们的主要结局是达到系统性红斑狼疮反应指数-4（SRI-4）应答的患者比例。共有三项 RCT，纳入 1849 名患者，符合纳入标准。巴利昔替尼 4 mg 组在第 24 周达到 SRI-4 应答的患者比例显著更高（RR=1.19，95%CI[1.05，1.35]，P<0.01）。然而，在第 52 周时，巴利昔替尼 4 mg 组和第 24 周和第 52 周时的巴利昔替尼 2 mg 组均未达到统计学意义（RR=1.13，95%CI[0.96，1.34]，P=0.15；RR=1.09，95%CI[0.96，1.24]，P=0.20；RR=1.05，95%CI[0.92，1.19]，P=0.50）。巴利昔替尼 4 mg 组严重感染的风险更高（RR=2.23，95%CI[1.13，4.37]，P=0.02）。巴利昔替尼 2 mg 并未显示出任何临床获益。相比之下，巴利昔替尼 4 mg 可能具有降低 SLE 疾病活动度的潜力；然而，需要进一步的研究来评估其长期疗效。在开发出更高质量的证据之前，在开始巴利昔替尼治疗之前，应考虑其获益和风险。主要观点 • 巴利昔替尼是一种选择性的 Janus 激酶抑制剂，最近已被批准用于治疗某些自身免疫性疾病；然而，其在系统性红斑狼疮（SLE）患者中的疗效仍不确定。 • 在我们的荟萃分析中，巴利昔替尼 2 mg 没有显示出任何临床获益。相比之下，巴利昔替尼 4 mg 在第 24 周时显著降低了 SLE 活性，达到了 SRI-4 应答。然而，在第 52 周时，这并未达到统计学意义。 • 需要进一步的研究来探讨巴利昔替尼 4 mg 在 SLE 患者中的长期疗效。
