Efficacy and safety of jakinibs in rheumatoid arthritis: a systematic review and meta-analysis
Efficacy and safety of jakinibs in rheumatoid arthritis: a systematic review and meta-analysis
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jakinibs 在类风湿性关节炎中的疗效和安全性：系统评价和荟萃分析
DOI：
10.1007/s10067-021-05686-8
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发表时间：
--
影响因子：
3.4
通讯作者：
Wu Jian
中科院分区：
文献类型：
--
作者：
Yin Yufeng;Liu Mengru;Zhou Erye;Chang Xin;He Michun;Wang Mingjun;Wu Jian
目的评价雅克尼布治疗对常规合成或生物抗风湿药物(DMARDS)反应不足或不耐受的活动期类风湿性关节炎(RA)的疗效和安全性。雅吉尼在RA患者中的随机安慰剂对照试验(RCT)是合格的。有效的结果是RA改善，在治疗后12周和24周达到美国风湿病学会20%/50%/70%(ACR20/50/70)的应答率。安全性结果包括治疗突发不良事件(TEAE)、严重不良事件(SAE)以及因不良事件、感染和严重感染而停药。结果纳入28项随机、双盲、对照试验，包括14,500名患者。在12周和24周，合并分析建议使用jakinibs进行有效治疗，表现为ACR20、ACR50和ACR70的临床反应增加。根据不同类型的Jakinibs进行的亚组分析表明，在12周时，仅使用培菲替尼治疗对ACR50或ACR70的临床疗效没有影响。在12周时，Jakinibs与感染的发生率增加，在24周时与TEAE和感染的发生率增加相关。在这些患者中，接受雅奇尼布治疗和服用安慰剂的患者发生SAE、因不良事件而中止治疗或严重感染的风险没有增加。结论雅奇尼布对RA患者在24周内是有效的，耐受性良好，但它们与感染并发症的风险增加有关。关键点·接受雅奇尼布治疗的患者的ACR20/50/70显著高于接受安慰剂治疗的患者。·在接受培非替尼和安慰剂治疗的RA患者中，ACR50/70没有差异。·雅奇尼布在RA治疗中是有益的，耐受性良好。
ObjectivesTo 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).MethodsA 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.ResultsTwenty-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.ConclusionsJakinibs 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.