Transparency in Healthcare BV, Hengelo, Netherlands
Erasmus School of Health Policy and Management, Erasmus Universiteit Rotterdam, Rotterdam, Zuid-Holland, Netherlands.
RMD Open. 2024 May 30;10(2):e004291. doi: 10.1136/rmdopen-2024-004291.
To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a real-life treat-to-target (T2T) setting.
Patients with biological and targeted synthetic DMARD (b/tsDMARD) naïve RA with disease duration ≤5 years without contraindications to b/tsDMARD were randomised to either TNFi or baricitinib when csDMARD failed to achieve disease control in a T2T setting. Changes in clinical and patient-reported outcome measures (PROMs) were assessed at 12-week intervals for 48 weeks. The primary endpoint was non-inferiority, with testing for superiority if non-inferiority is demonstrated, of baricitinib strategy in the number of patients achieving American College of Rheumatology 50 (ACR50) response at 12 weeks. Secondary endpoints included 28-joint count Disease Activity Score with C reactive protein (DAS28-CRP) <2.6, changes in PROMs and radiographic progression.
A total of 199 patients (TNFi, n=102; baricitinib, n=97) were studied. Both study groups were similar. Baricitinib was both non-inferior and superior in achieving ACR50 response at week 12 (42% vs 20%). Moreover, 75% of baricitinib patients achieved DAS28-CRP <2.6 at week 12 compared with 46% of TNFi patients. On secondary outcomes throughout the duration of the study, the baricitinib strategy demonstrated comparable or better outcomes than TNFi strategy. Although not powered for safety, no unexpected safety signals were seen in this relatively small group of patients.
Up to present, in a T2T setting, patients with RA failing csDMARDs have two main strategies to consider, Janus Kinases inhibitor versus bDMARDs (in clinical practice, predominantly TNFi). The PERFECTRA study suggested that starting with baricitinib was superior over TNFi in achieving response at 12 weeks and resulted in improved outcomes across all studied clinical measures and PROMs throughout the study duration in these patients.
在真实的达标治疗（T2T）环境下，比较类风湿关节炎（RA）患者在传统合成改善病情抗风湿药物（csDMARDs）失败后使用巴瑞替尼与使用肿瘤坏死因子抑制剂（TNFi）的策略的疗效。
纳入生物和靶向合成 DMARD（b/tsDMARD）初治、疾病持续时间≤5 年且无 b/tsDMARD 禁忌证的 RA 患者，在 T2T 环境下 csDMARD 未能控制疾病时，随机分配至 TNFi 组或巴瑞替尼组。在 48 周的时间内，每 12 周评估一次临床和患者报告结局测量（PROMs）的变化。主要终点是巴瑞替尼策略在第 12 周时达到美国风湿病学会 50 项应答（ACR50）的患者比例不劣于 TNFi 策略，如证明不劣效性，则进行优效性检验。次要终点包括 28 关节疾病活动度评分（DAS28）伴 C 反应蛋白（DAS28-CRP）＜2.6、PROMs 和影像学进展的变化。
共纳入 199 例患者（TNFi 组 102 例，巴瑞替尼组 97 例）。两组患者相似。第 12 周时，巴瑞替尼在达到 ACR50 应答方面既不劣效又优于 TNFi 策略（42%比 20%）。此外，巴瑞替尼组有 75%的患者在第 12 周时达到 DAS28-CRP＜2.6，而 TNFi 组为 46%。在整个研究期间的次要结局中，巴瑞替尼策略的结果与 TNFi 策略相当或更优。尽管本研究未对安全性进行统计学分析，但在这组相对较小的患者中未观察到意外的安全性信号。
在 T2T 环境下，csDMARD 失败的 RA 患者有两种主要策略可供考虑，Janus 激酶抑制剂与 bDMARDs（在临床实践中，主要是 TNFi）。PERFECTRA 研究表明，在第 12 周时，起始使用巴瑞替尼比起始使用 TNFi 更优，在这些患者中，在所有研究的临床指标和 PROMs 方面均能改善结局。
