Department of Rheumatology, College of Medicine, Korea University, Seoul, Korea.
Lupus. 2023 Nov;32(13):1493-1500. doi: 10.1177/09612033231208842. Epub 2023 Oct 18.
This study aimed to evaluate the safety and effectiveness of baricitinib in patients with systemic lupus erythematosus (SLE).
We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register to find relevant publications. Using data from randomized controlled trials (RCTs), we performed a meta-analysis to investigate the safety and efficacy of baricitinib in patients with active SLE who did not respond well to standard treatments.
A total of 1849 individuals (1235 experimental participants and 614 controls) from three RCTs on baricitinib were included. A reduction of ≥ 4 points from baseline in SLEDAI-2K score in the baricitinib 4 mg group was greater than the placebo group's reduction (odds ratio [OR] = 1.407, 95% confidence interval [CI] 1.123-1.763, = .003). The baricitinib 4 mg group significantly outperformed the placebo group in terms of SLEDAI-2K remission of arthritis or rash (OR = 1.327, 95% CI = 1.059-1.663, = .014). Other effectiveness outcomes such as the SRI4 response did not substantially improve in the baricitinib 4 mg group when compared with the placebo group. And there were no significant increase in the efficacy outcomes in the baricitinib 2 mg group than in the placebo group. However, there was a substantially higher incidence of severe adverse events (SAE) and serious infections in the baricitinib 4 mg group (OR = 1.493, 95% CI = 1.002-2.225, = .049; OR = 2.303, 95% CI = 1.147-4.622, = .019) compared to the placebo group. There were no differences between the baricitinib 2 mg and placebo groups in any of the safety outcome data.
Meta-analysis reveals that baricitinib 4 mg is beneficial for treating active SLE in terms of a reduction of ≥ 4 points from baseline in SLEDAI-2K score and SLEDAI-2K remission of arthritis or rash. However, the higher frequency of SAEs and serious infections was observed in the group receiving baricitinib 4 mg.
本研究旨在评估巴利昔替尼治疗系统性红斑狼疮（SLE）患者的安全性和有效性。
我们检索了 MEDLINE、EMBASE 和 Cochrane 对照试验注册库，以寻找相关文献。使用来自随机对照试验（RCT）的数据，我们进行了荟萃分析，以调查巴利昔替尼在对标准治疗反应不佳的活动期 SLE 患者中的安全性和疗效。
共有来自 3 项巴利昔替尼 RCT 的 1849 名个体（1235 名实验组和 614 名对照组）纳入本研究。巴利昔替尼 4mg 组从基线 SLEDAI-2K 评分下降≥4 分的患者比例大于安慰剂组（比值比 [OR] = 1.407，95%置信区间 [CI] 1.123-1.763， =.003）。巴利昔替尼 4mg 组在 SLEDAI-2K 缓解关节炎或皮疹方面显著优于安慰剂组（OR = 1.327，95% CI = 1.059-1.663， =.014）。与安慰剂组相比，巴利昔替尼 4mg 组的其他疗效终点，如 SRI4 反应，并没有显著改善。巴利昔替尼 2mg 组与安慰剂组相比，疗效终点也没有显著提高。然而，巴利昔替尼 4mg 组严重不良事件（SAE）和严重感染的发生率显著高于安慰剂组（OR = 1.493，95% CI = 1.002-2.225， =.049；OR = 2.303，95% CI = 1.147-4.622， =.019）。巴利昔替尼 2mg 组与安慰剂组在任何安全性结果数据上均无差异。
荟萃分析表明，巴利昔替尼 4mg 有利于治疗活动期 SLE，表现为从基线 SLEDAI-2K 评分下降≥4 分和 SLEDAI-2K 缓解关节炎或皮疹。然而，在接受巴利昔替尼 4mg 治疗的患者中，SAE 和严重感染的发生率更高。
