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Janus 激酶抑制剂治疗系统性红斑狼疮和皮肤型红斑狼疮的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of Janus kinase inhibitors in systemic and cutaneous lupus erythematosus: A systematic review and meta-analysis.

机构信息

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science & Technology, Beijing, China; State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China; Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science & Technology, Beijing, China; State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China; Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.

出版信息

Autoimmun Rev. 2023 Dec;22(12):103440. doi: 10.1016/j.autrev.2023.103440. Epub 2023 Sep 9.

DOI:10.1016/j.autrev.2023.103440
PMID:37678618
Abstract

BACKGROUND

Janus kinase (JAK) inhibitors have been proven to be effective and safe in various autoimmune diseases. However, there is still a lack of comprehensive evidence regarding their efficacy and safety in systemic and cutaneous lupus erythematosus.

METHODS

We searched for systemic and cutaneous lupus erythematosus patients who were treated with JAK inhibitors in PubMed, Embase, Web of Science, and the Cochrane Library until February 28, 2023. The quality of clinical trials was assessed using the Cochrane risk-of-bias tool. Meta-analysis was conducted when at least three studies had comparable measures of outcome. If meta-analysis was not feasible, a descriptive review was carried out.

RESULTS

We included 30 studies, consisting of 10 randomized controlled trials and 20 case series or reports, with a total of 2,460 patients. JAK inhibitors were found to be more effective than placebo in systemic lupus erythematosus (SLE) based on the percentage of achieving SLE Responder Index (SRI)-4 response (RR = 1.18; 95% CI 1.07 to 1.31; p = 0.001), British Isles Lupus Assessment Group -based Composite Lupus Assessment (BICLA) response (RR = 1.16; 95% CI 1.02 to 1.31; p = 0.02), Lupus Low Disease Activity State (LLDAS) (RR = 1.28; 95% CI 1.07 to 1.54; p = 0.008), and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2 K) remission of arthritis or rash (RR = 1.09; 95% CI 1.00 to 1.18; p = 0.04), particularly in treating musculoskeletal and mucocutaneous involvement. However, the effect of JAK inhibitors on cutaneous lupus erythematosus was uncertain. JAK inhibitors and placebo had a similar incidence of adverse events (RR = 1.01; 95% CI 0.97 to 1.04; p = 0.65).

CONCLUSION

JAK inhibitors could be a potential treatment option for systemic and cutaneous lupus erythematosus, particularly in treating cutaneous and musculoskeletal lesions of SLE. JAK inhibitors had a safe profile.

摘要

背景

Janus 激酶 (JAK) 抑制剂已被证明在各种自身免疫性疾病中有效且安全。然而,关于其在系统性和皮肤性红斑狼疮中的疗效和安全性,仍缺乏全面的证据。

方法

我们在 PubMed、Embase、Web of Science 和 Cochrane 图书馆中检索了接受 JAK 抑制剂治疗的系统性和皮肤性红斑狼疮患者,检索时间截至 2023 年 2 月 28 日。使用 Cochrane 偏倚风险工具评估临床试验的质量。如果至少有 3 项研究具有可比的结局衡量指标,则进行荟萃分析。如果无法进行荟萃分析,则进行描述性综述。

结果

我们纳入了 30 项研究,包括 10 项随机对照试验和 20 项病例系列或报告,共纳入 2460 例患者。基于系统性红斑狼疮应答指数 (SRI)-4 应答的百分比,JAK 抑制剂在系统性红斑狼疮 (SLE) 中的疗效优于安慰剂 (RR=1.18;95%CI 1.07 至 1.31;p=0.001)、基于不列颠群岛狼疮评估组的综合狼疮评估 (BICLA) 应答 (RR=1.16;95%CI 1.02 至 1.31;p=0.02)、狼疮低疾病活动状态 (LLDAS) (RR=1.28;95%CI 1.07 至 1.54;p=0.008) 和系统性红斑狼疮疾病活动指数 2000 (SLEDAI-2K) 关节炎或皮疹缓解 (RR=1.09;95%CI 1.00 至 1.18;p=0.04),特别是在治疗肌肉骨骼和黏膜皮肤受累方面。然而,JAK 抑制剂对皮肤性红斑狼疮的疗效尚不确定。JAK 抑制剂和安慰剂的不良反应发生率相似 (RR=1.01;95%CI 0.97 至 1.04;p=0.65)。

结论

JAK 抑制剂可能是系统性和皮肤性红斑狼疮的一种潜在治疗选择,特别是在治疗 SLE 的皮肤和肌肉骨骼病变方面。JAK 抑制剂具有安全的特性。

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