JAKinibs 在类风湿关节炎中的疗效和安全性：系统评价和荟萃分析。
Efficacy and safety of jakinibs in rheumatoid arthritis: a systematic review and meta-analysis.
机构信息
Department of Rheumatology, The First Affiliated Hospital of Soochow University, No. 188 Shizi St, Suzhou, 215006, Jiangsu, China.
Department of Rheumatology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
出版信息
Clin Rheumatol. 2021 Oct;40(10):3989-4005. doi: 10.1007/s10067-021-05686-8. Epub 2021 May 14.
OBJECTIVES
To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs).
METHODS
A systematic search was conducted in PubMed, Embase, and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at weeks 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events, infections, and serious infections.
RESULTS
Twenty-eight randomized, double-blind, controlled trials including 14,500 patients were included. At both weeks 12 and 24, the pooled analysis suggested effective treatment with jakinibs, represented as an increased clinical response of ACR20, ACR50, and ACR70. Subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients.
CONCLUSIONS
Jakinibs are efficacious and well tolerated in RA patients up to 24 weeks, although they are associated with an increased risk of infectious complications. Key Points • ACR20/50/70 in patients treated with jakinibs was significantly higher than those in patients treated with placebo. • No difference in ACR50/70 was observed in patients with RA treated with peficitinib and placebo. • Jakinibs are beneficial and well tolerated in RA treatment.
目的
评估 Jakinibs 治疗对传统合成或生物改善病情抗风湿药物（DMARDs）应答不足或不耐受的活动性类风湿关节炎（RA）患者的疗效和安全性。
方法
对 PubMed、Embase 和 Cochrane Library 进行系统检索。纳入 Jakinibs 治疗 RA 患者的随机安慰剂对照试验（RCT）。有效的结局是治疗后 12 周和 24 周时达到美国风湿病学会 20%/50%/70%（ACR20/50/70）应答率的 RA 改善。安全性结局包括治疗中出现的不良事件（TEAEs）、严重不良事件（SAEs）以及因不良事件、感染和严重感染而停药。
结果
共纳入 28 项随机、双盲、对照试验，包括 14500 例患者。在治疗后 12 周和 24 周时，汇总分析提示 Jakinibs 治疗有效，表现为 ACR20、ACR50 和 ACR70 的临床应答增加。基于不同类型的 Jakinibs 的亚组分析表明，仅培非替尼治疗在第 12 周时对 ACR50 或 ACR70 的临床应答没有影响。Jakinibs 在第 12 周时与感染发生率增加以及 TEAEs 和第 24 周时感染相关。在这些患者中，与安慰剂相比，Jakinibs 治疗并未增加 SAE、因不良事件停药或严重感染的风险。
结论
Jakinibs 在 RA 患者中治疗 24 周是有效且耐受良好的，尽管它们与感染并发症风险增加相关。关键点：• 接受 Jakinibs 治疗的患者的 ACR20/50/70 显著高于接受安慰剂治疗的患者。• 接受培非替尼和安慰剂治疗的 RA 患者的 ACR50/70 无差异。• Jakinibs 在 RA 治疗中是有益且耐受良好的。
Zotero 插件