Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases and Hanyang University Institute for Rheumatology Research, Seoul, Korea.
Division of Rheumatology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
Korean J Intern Med. 2023 Jul;38(4):546-556. doi: 10.3904/kjim.2022.369. Epub 2023 Jun 20.
BACKGROUND/AIMS: We aimed to compare the effectiveness and safety of Janus kinase inhibitors (JAKi) vs. biologic disease- modifying antirheumatic drugs (bDMARD) in Korean patients with rheumatoid arthritis (RA) who had an inadequate response to conventional synthetic DMARDs.
A quasi-experimental, multi-center, prospective, non-randomized study was conducted to compare response rates between JAKi and bDMARDs in patients with RA naïve to targeted therapy. An interim analysis was performed to estimate the proportion of patients achieving low disease activity (LDA) based on disease activity score (DAS)-28- erythroid sedimentation rate (ESR) (DAS28-ESR) at 24 weeks after treatment initiation and to evaluate the development of adverse events (AEs).
Among 506 patients enrolled from 17 institutions between April 2020 and August 2022, 346 (196 JAKi group and 150 bDMARD group) were included in the analysis. After 24 weeks of treatment, 49.0% of JAKi users and 48.7% of bDMARD users achieved LDA (p = 0.954). DAS28-ESR remission rates were also comparable between JAKi and bDMARD users (30.1% and 31.3%, respectively; p = 0.806). The frequency of AEs reported in the JAKi group was numerically higher than that in the bDMARDs group, but the frequencies of serious and severe AEs were comparable between the groups.
Our interim findings reveal JAKi have comparable effectiveness and safety to bDMARDs at 24 weeks after treatment initiation.
背景/目的:我们旨在比较 Janus 激酶抑制剂(JAKi)与生物疾病修正抗风湿药物(bDMARD)在对传统合成疾病修正抗风湿药物(csDMARD)反应不足的韩国类风湿关节炎(RA)患者中的疗效和安全性。
进行了一项准实验、多中心、前瞻性、非随机研究,以比较 RA 患者对靶向治疗无反应的患者中 JAKi 和 bDMARD 之间的缓解率。进行了中期分析,以估计根据治疗开始后 24 周时疾病活动评分(DAS)-28-红细胞沉降率(ESR)(DAS28-ESR)达到低疾病活动度(LDA)的患者比例,并评估不良事件(AE)的发展。
在 2020 年 4 月至 2022 年 8 月期间从 17 个机构纳入的 506 名患者中,346 名(196 名 JAKi 组和 150 名 bDMARD 组)被纳入分析。治疗 24 周后,JAKi 使用者中有 49.0%和 bDMARD 使用者中有 48.7%达到 LDA(p=0.954)。JAKi 和 bDMARD 使用者的 DAS28-ESR 缓解率也相当(分别为 30.1%和 31.3%;p=0.806)。JAKi 组报告的 AE 频率略高于 bDMARDs 组,但两组严重和严重 AE 的频率相当。
我们的中期发现表明,在治疗开始后 24 周时,JAKi 与 bDMARD 具有相当的疗效和安全性。