Department of Rheumatology, Faculty of Medicine, University Hospital "St. Ivan Rilski", Medical University of Sofia, 13 Urvich str, 1612, Sofia, Bulgaria.
Faculty of Pharmacy, Medical University of Sofia, 1000, Sofia, Bulgaria.
Rheumatol Int. 2022 Oct;42(10):1775-1783. doi: 10.1007/s00296-022-05163-8. Epub 2022 Jun 27.
The aim of this study was to analyze the therapeutic results of rheumatoid arthritis (RA) therapy with different biologic disease-modifying antirheumatic drugs (bDMARDs) and the first Janus-activated kinase (JAK) inhibitor in real-life clinical settings. This is a prospective, observational, longitudinal study at the largest rheumatology clinic in Bulgaria conducted during the period 2012-2020. One hundred seventy-four patients were followed up for a period of one year. Patients naïve to biological therapy were consecutively assigned on the available at the time bDMARDs (infliximab, etanercept, adalimumab, rituximab, golimumab, cetrolizumab, tocilizumab) or tofacitinib. We evaluated the disease activity score (DAS28-CRP), Health assessment questionnaires (HAQ) and short form 36 (SF-36) were applied at the initiation of biological therapy, after 6, and 12 months of follow-up. We analyze the changes in the two major subgroups of SF36-physical (MCS) and mental health (PCS). The age and gender distribution were similar between the groups on bDMARDs and tsDMARD. All observed indicators for disease control and QoL improve after the initiation of the biological or JAK inhibitor therapy. We also analyze the effect of therapies on DAS28-CRP, HAQ, SF-36 (PCS, MCS). Dispersion analysis for the effect of therapy measured through DAS28 between 1st and 3rd measurement shows a statically significant difference in between the average effect of therapies (p = 0.005). According to the average change in DAS28 between the first and third measurement the most effective is the golimumab (Median difference = 2.745), followed by rituximab (median = 2.305) and etanercept (median = 2.070). According to the average change in HAQ between first and third the most effective is tofacitinib (median 0.563), followed rituximab and infliximab (median 0.500 for both). Less effective in term of HAQ changes between the first and third measurement appears to be etanercept (median difference 0.250). All differences are statistically significant (p < 0.05). Regarding the changes in the QoL measured with SF-36 MCS and PCS there is no statistically significant differences in the average effect of different therapeutic agents. Tofacitinib is non-inferior in comparison to bDMARDs and improve both-disease activity and QoL in patients with RA.
这项研究的目的是分析在真实临床环境中使用不同的生物疾病修饰抗风湿药物(bDMARDs)和第一代 Janus 激活激酶(JAK)抑制剂治疗类风湿关节炎(RA)的治疗结果。这是在保加利亚最大的风湿病诊所进行的一项前瞻性、观察性、纵向研究,时间为 2012 年至 2020 年。174 名患者接受了为期一年的随访。接受生物治疗的患者为首次接受生物治疗的患者,他们被连续分配使用当时可用的 bDMARDs(英夫利昔单抗、依那西普、阿达木单抗、利妥昔单抗、戈利木单抗、塞妥珠单抗、托法替布)或托法替布。我们评估了疾病活动评分(DAS28-CRP),在开始生物治疗时、治疗后 6 个月和 12 个月应用健康评估问卷(HAQ)和简明 36 项健康调查量表(SF-36)。我们分析了 SF36 中两个主要亚组的变化-身体(MCS)和心理健康(PCS)。bDMARD 组和 tsDMARD 组的年龄和性别分布相似。在开始生物或 JAK 抑制剂治疗后,所有观察到的疾病控制和生活质量指标均有所改善。我们还分析了治疗对 DAS28-CRP、HAQ、SF-36(PCS、MCS)的影响。通过 DAS28 测量的治疗效果的分散分析显示,治疗效果的平均值之间存在统计学显著差异(p=0.005)。根据 DAS28 第一和第三次测量之间的平均变化,最有效的是戈利木单抗(中位数差异=2.745),其次是利妥昔单抗(中位数=2.305)和依那西普(中位数=2.070)。根据 HAQ 第一次和第三次测量之间的平均变化,最有效的是托法替布(中位数 0.563),其次是利妥昔单抗和英夫利昔单抗(中位数均为 0.500)。在 HAQ 第一次和第三次测量之间的变化方面,依那西普似乎效果较差(中位数差异 0.250)。所有差异均具有统计学意义(p<0.05)。关于 SF-36 MCS 和 PCS 测量的生活质量变化,不同治疗药物的平均疗效无统计学差异。托法替布与 bDMARDs 相比不劣效,可改善 RA 患者的疾病活动度和生活质量。