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Abstract：
OBJECTIVE: This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort.
METHODS: We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.
RESULTS: A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.
CONCLUSIONS: BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.
METHODS: We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.
RESULTS: A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.
CONCLUSIONS: BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.
摘要：
目的：这项观察性研究比较了巴利替尼（BARI）的有效性，一种靶向合成的改善疾病的抗风湿药（tsDMARD），类风湿关节炎（RA）患者的替代生物DMARDs（bDMARDs），从一个潜在的，纵向队列。
方法：我们比较了开始BARI治疗疗程（TC）的患者，肿瘤坏死因子抑制剂（TNFi）或具有其他作用方式的bDMARDs（OMA），在瑞士所有这些DMARD都可用的时期。主要结果是药物维持；次要结果包括与无效和不良事件相关的停药率。我们进一步分析了bDMARD-naive和tsDMARD-naive人群中12个月的低疾病活动（LDA）和缓解（REM）率以及药物维持率。
结果：总共包括1053个TC：在BARI上有273个TC，TNFi上的473和OMA上的307。与TNFi相比，BARI被用于疾病持续时间更长，以前治疗失败更多的老年患者。与BARI相比,TNFi的校正药物维持时间显著缩短(停药时的HR:1.76;95%CI,1.32~2.35),但与OMA(HR1.27;95%CI,0.93~1.72)相比没有.这些结果在b/tsDMARD初治人群中相似。更高的TNFi停药主要是由于无效停药增加（HR1.49;95％CI，1.03至2.15），药物停药的不良事件没有显着差异（HR1.46;95％CI，0.83至2.57）。在12个月时，三组的LDA和REM率没有显着差异。
结论：与TNFi相比，BARI显示出更高的药物维持率，主要是由于无效的药物停药率较低。我们发现BARI和OMA在药物维持方面没有差异。三组之间的临床结果没有差异。我们的结果表明，在RA的治疗中，BARI是bDMARDs的适当替代治疗方法。
方法：我们比较了开始BARI治疗疗程（TC）的患者，肿瘤坏死因子抑制剂（TNFi）或具有其他作用方式的bDMARDs（OMA），在瑞士所有这些DMARD都可用的时期。主要结果是药物维持；次要结果包括与无效和不良事件相关的停药率。我们进一步分析了bDMARD-naive和tsDMARD-naive人群中12个月的低疾病活动（LDA）和缓解（REM）率以及药物维持率。
结果：总共包括1053个TC：在BARI上有273个TC，TNFi上的473和OMA上的307。与TNFi相比，BARI被用于疾病持续时间更长，以前治疗失败更多的老年患者。与BARI相比,TNFi的校正药物维持时间显著缩短(停药时的HR:1.76;95%CI,1.32~2.35),但与OMA(HR1.27;95%CI,0.93~1.72)相比没有.这些结果在b/tsDMARD初治人群中相似。更高的TNFi停药主要是由于无效停药增加（HR1.49;95％CI，1.03至2.15），药物停药的不良事件没有显着差异（HR1.46;95％CI，0.83至2.57）。在12个月时，三组的LDA和REM率没有显着差异。
结论：与TNFi相比，BARI显示出更高的药物维持率，主要是由于无效的药物停药率较低。我们发现BARI和OMA在药物维持方面没有差异。三组之间的临床结果没有差异。我们的结果表明，在RA的治疗中，BARI是bDMARDs的适当替代治疗方法。
