对巴尼妥单抗治疗类风湿性关节炎的实际世界证据进行系统文献综述。
Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis.
发表日期:2023 Sep 16
作者:
Blanca Hernández-Cruz, Uta Kiltz, Jérôme Avouac, Tamas Treuer, Ewa Haladyj, Jens Gerwien, Chandreyee Dutta Gupta, Fabrizio Conti
来源:
Arthritis & Rheumatology
摘要:
巴利西替尼是一种口服小分子Janus 激酶(JAK)1和JAK2抑制剂,用于治疗活动中度至重度类风湿性关节炎(RA)。该系统回顾性研究描述了接受巴利西替尼治疗的RA患者的实际临床特征、处方模式、疗效、药物持续时间、患者报告的结果(PROs; 生理功能、疼痛、与健康相关的生活质量[HRQoL])、患者整体评估(PGA)以及巴利西替尼的安全性。我们进行了一个PRISMA系统回顾性研究,以识别在 2016 年 1 月至 2022 年 9 月期间在MEDLINE®、EMBASE® 和基于循证医学的评论数据库中发表的相关文献。我们手动搜索了美国风湿病学院和欧洲风湿联盟的网站或在线数据存储库,以包括 2016 年 1 月至 2022 年 11 月举办的会议的相关摘要。通过搜索在线数据库,共确定了 11,472 份记录。研究中包含了 70 份研究,其中 40 份为摘要。大多数患者年龄较大(51-71岁),女性,患有RA平均持续时间为4-19年。在一个或多个生物制剂靶向综合病因用药失败后,巴利西替尼主要用于RA患者(剂量为4毫克,范围22-100%)。巴利西替尼在实际临床中的临床疗效报告不受先前生物制剂或靶向合成疾病修饰抗风湿药物(DMARD)用药和伴随使用常规合成DMARD的影响。在第12周,8.7-60%的患者达到临床疾病活动指数(CDAI)缓解,第24周,20.2-81.6%的患者达到CDAI低疾病活动指数(LDA)。Simple Disease Activity Index(SDAI)缓解患者的比例从第4周的12%至第24周的45.4%。药物持续时间高,与抗肿瘤坏死因子药物相当。没有发现新的安全信号。巴利西替尼在实际临床中证明了其有效性,观察到了与临床研究一致的安全性。与生物制剂相比,巴利西替尼的持续率更高,并且改善了PROs,尽管接受巴利西替尼治疗的患者具有不良预后特征。© 2023年。作者。
Baricitinib, an orally available small-molecule inhibitor of Janus kinase (JAK)1 and JAK2, is indicated to treat active moderate-to-severe rheumatoid arthritis (RA).This systematic review described the real-world clinical characteristics of baricitinib-treated patients with RA, prescription patterns, effectiveness, drug persistence, patient-reported outcomes (PROs; physical function, pain, health-related quality of life [HRQoL]), patient global assessment (PGA), and safety of baricitinib.A PRISMA systematic review of real-world studies was conducted to identify relevant literature published between January 2016 and September 2022 using MEDLINE®, EMBASE®, and evidence-based medicine review databases. Websites or online repositories of the American College of Rheumatology and the European Alliance of Associations for Rheumatology were searched manually to include relevant abstracts from conferences held between January 2016 and November 2022.A total of 11,472 records were identified by searching online databases. Seventy studies were included in the study, of which 40 were abstracts. Most patients were older (51-71 years), female, and with mean RA duration of 4-19 years. Baricitinib was mostly used after the failure of one or more bDMARDs, and 4 mg dosing was prevalent in patients with RA (range 22-100%). Clinical effectiveness of baricitinib was reported in real-world settings regardless of prior biologic/targeted synthetic disease-modifying antirheumatic drug (DMARD) use and concomitant conventional synthetic DMARD use. Achievement of Clinical Disease Activity Index (CDAI) remission was reported in 8.7-60% of patients at week 12 and CDAI low disease activity (LDA) in 20.2-81.6% at week 24. The proportion of patients attaining Simple Disease Activity Index (SDAI) remission was reported in 12% at week 4 to 45.4% at 24 weeks. Drug persistence was high, similar, or equal to anti-tumor necrosis factor drugs. No new safety signals were identified.Baricitinib demonstrated effectiveness in the real-world setting with a consistent safety profile observed in clinical studies. Better persistence rates for baricitinib compared to bDMARDs with improvement in PROs were reported, although baricitinib-treated patients had RA with poor prognostic characteristics.© 2023. The Author(s).