PDF(Pubmed)
Abstract：
Background/Aim: Baricitinib (BAR) is the first oral selective Janus kinase inhibitor approved in Europe for rheumatoid arthritis (RA). Real-world data are still needed to clarify its long-term benefits/risk profile. This study aimed to evaluate the effectiveness, persistence, adherence, and safety of BAR in a real-world setting. Methods: An ambispective study was conducted between October 2017 and December 2021 in RA patients starting BAR. The effectiveness was evaluated, assessing changes from the baseline of the Disease Activity Score using 28-joint counts-C reactive protein (DAS28CRP), and the achievement of low disease activity/remission. Drug persistence was evaluated using Kaplan-Meier analysis. Adherence was estimated using the medication possession ratio (MPR) and the 5-item Compliance Questionnaire for Rheumatology. Safety was assessed determining global incidence proportion and adverse event adjusted incidence rates. Results: In total, 61/64 recruited patients were finally analyzed, 83.6% were female, 78.7% were seropositive, the mean age was 58.1 (15.4) years, and the disease duration was 13.9 (8.3) years. A total of 32.8% of patients were naïve to biologics and 16.4% received BAR as monotherapy. The median exposure to BAR was 12.4 (6.6-31.2) months (range 3.1-51.4). A significant change in DAS28CRP was observed after treatment (difference -1.2, p = 0.000). 70.5% and 60.7% of patients achieved low disease activity or remission, respectively, and 50.8% (31/61) remained on BAR throughout the follow-up, with a median persistence of 31.2 (9.3-53.1) months. The average MPR was 0.96 (0.08) and all patients exhibited \"good adherence\" according to the questionnaire. In total, 21.3% of patients discontinued baricitinib due to toxicity. Conclusions: In our real-world practice, BAR demonstrated effectiveness, large persistence, high adherence to treatment, and an acceptable safety profile.
摘要：
背景/目的：Baricitinib（BAR）是第一个在欧洲批准用于类风湿关节炎（RA）的口服选择性Janus激酶抑制剂。仍然需要现实世界的数据来阐明其长期利益/风险状况。本研究旨在评估有效性，持久性,坚持,以及在现实世界中BAR的安全性。方法：2017年10月至2021年12月对开始BAR的RA患者进行了一项综合研究。对有效性进行了评估，使用28关节计数-C反应蛋白（DAS28CRP）评估疾病活动评分的基线变化，和实现低疾病活动/缓解。使用Kaplan-Meier分析评估药物持久性。使用药物占有比（MPR）和风湿病学5项依从性问卷评估依从性。安全性评估确定全球发生率比例和不良事件调整后的发生率。结果：总的来说，最终分析了61/64名招募的患者，83.6%为女性，78.7%为血清阳性,平均年龄为58.1（15.4）岁，病程为13.9(8.3)年。共有32.8％的患者未接受生物制剂治疗，16.4％的患者接受BAR作为单一疗法。BAR暴露的中位数为12.4（6.6-31.2）个月（范围3.1-51.4）。治疗后观察到DAS28CRP的显着变化（差异-1.2，p=0.000）。70.5%和60.7%的患者实现了低疾病活动性或缓解，分别,在整个随访期间，50.8%(31/61)仍在BAR上，中位持续时间为31.2(9.3-53.1)个月。平均MPR为0.96（0.08），根据问卷，所有患者均表现出“良好的依从性”。总的来说,21.3%的患者因毒性而停用baricitinib。结论：在我们现实世界的实践中，BAR证明了有效性，大的持久性，高度坚持治疗，和可接受的安全性。
