Targeted small-molecule drugs in the treatment of systemic lupus erythematosus (SLE) have attracted increasing attention from clinical investigators. However, there is still a lack of evidence on the difference in the efficacy and safety of different targeted small-molecule drugs. Therefore, this study was conducted to assess the efficacy and safety of different targeted small-molecule drugs for SLE. Randomized controlled trials (RCTs) on targeted small-molecule drugs in the treatment of SLE in PubMed, Web of Science, Embase, and Cochrane Library were systematically searched as of April 25, 2023. Risk of bias assessment was performed for included studies using the Cochrane’s tool for evaluating the risk of bias. The primary outcome indicators were SRI-4 response, BICLA response, and adverse reaction. Because different doses and courses of treatment were used in the included studies, Bayesian network meta-regression was used to investigate the effect of different doses and courses of treatment on efficacy and safety. A total of 13 studies were included, involving 3,622 patients and 9 targeted small-molecule drugs. The results of network meta-analysis showed that, in terms of improving SRI-4, Deucravacitinib was significantly superior to that of Baricitinib (RR = 1.32, 95% CI (1.04, 1.68), P < 0.05). Deucravacitinib significantly outperformed the placebo in improving BICLA response (RR = 1.55, 95% CI (1.20, 2.02), P < 0.05). In terms of adverse reactions, targeted small-molecule drugs did not significantly increase the risk of adverse events as compared to placebo (P > 0.05). Based on the evidence obtained in this study, the differences in the efficacy of targeted small-molecule drugs were statistically significant as compared to placebo, but the difference in the safety was not statistically significant. The dose and the course of treatment had little impact on the effect of targeted small-molecule drugs. Deucravacitinib could significantly improve BICLA response and SRI-4 response without significantly increasing the risk of AEs. Therefore, Deucravacitinib is very likely to be the best intervention measure. Due to the small number of included studies, more high-quality clinical evidence is needed to further verify the efficacy and safety of targeted small-molecule drugs for SLE.

中文翻译：

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靶向小分子药物治疗系统性红斑狼疮的疗效及安全性研究

靶向小分子药物治疗系统性红斑狼疮（SLE）越来越受到临床研究者的关注。然而，目前仍缺乏证据表明不同靶向小分子药物的疗效和安全性差异。因此，本研究旨在评估不同靶向小分子药物治疗 SLE 的疗效和安全性。截至 2023 年 4 月 25 日，系统检索了 PubMed、Web of Science、Embase 和 Cochrane 图书馆中关于靶向小分子药物治疗 SLE 的随机对照试验 (RCT)。使用以下方法对纳入的研究进行偏倚风险评估： Cochrane 评估偏倚风险的工具。主要结局指标是SRI-4反应、BICLA反应和不良反应。由于纳入研究中采用了不同剂量和疗程，因此采用贝叶斯网络元回归探讨不同剂量和疗程对疗效和安全性的影响。共纳入13项研究，涉及3622名患者和9种靶向小分子药物。网络meta分析结果显示，在改善SRI-4方面，Deucravacitinib明显优于Baricitinib（RR = 1.32，95% CI（1.04，1.68），P < 0.05）。 Deucravacitinib 在改善 BICLA 反应方面显着优于安慰剂（RR = 1.55，95% CI (1.20, 2.02)，P < 0.05）。不良反应方面，与安慰剂相比，靶向小分子药物并未显着增加不良事件风险（P > 0.05）。根据本研究获得的证据，与安慰剂相比，靶向小分子药物的疗效差异具有统计学意义，但安全性差异不具有统计学意义。剂量和疗程对靶向小分子药物的效果影响不大。 Deucravacitinib 可以显着改善 BICLA 反应和 SRI-4 反应，而不会显着增加 AE 风险。因此，Deucravacitinib很可能是最好的干预措施。由于纳入研究数量较少，需要更多高质量的临床证据来进一步验证靶向小分子药物治疗SLE的有效性和安全性。