Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Marmara University, İstanbul, Turkey.
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Akdeniz University, Antalya, Turkey.
Turk J Med Sci. 2023 Jun;53(3):731-743. doi: 10.55730/1300-0144.5636. Epub 2023 Jun 19.
To describe the disease activity and retention rate in rheumatoid arthritis (RA) patients with inadequate response (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or tumor necrosis factor inhibitors (TNFis) who were prescribed tocilizumab (TCZ) as first-line or second-line biologic treatment in real-world setting.
Data gathered from patients' files was used in a multicenter and retrospective context. Retention rates and the Disease Activity Score in 28 joints with CRP (DAS28-CRP) were evaluated at time points. The relationship of drug efficacy with factors such as smoking, obesity, and previous use of TNFis was also examined.
One hundred and twenty-four patients with a median (IQR) RA duration of 3.7 (7.4) years were included. Mean (SD) age was52.9 (12.9) and 75% of the patients were female. TCZ retention rates in the 6th and 12th months were 94.1% and 86.6%, respectively. In all patients, DAS28-CRP level decreased significantly from baseline to Months 3 and 6. There was an increase in patients with remission and/or low disease activity and a decrease in patients with high disease activity at Month 3 and Month 6 (p < 0.001 for both). Disease activity was similar between subgroups based on body mass index, smoking status, and previous use of TNFis at any time point. Regression analysis showed that absence of concomitant corticosteroid treatment independently was associated with remission/LDA achievement at Month 6 [OR = 0.31, 95% CI (0.14- 0.72), p = 0.006], and Month 12 [OR = 0.35, 95% CI (0.13-0.94), p = 0.037]. Overall, 25 mild adverse events were reported.
TCZ was found to be effective and safe in RA patients with IR to csDMARDs and/or TNFis. The drug retention rate was considered satisfactory with more than half of the patients continuing TCZ treatment at Month 12.
描述在常规合成疾病修饰抗风湿药物（csDMARDs）和/或肿瘤坏死因子抑制剂（TNFis）治疗反应不足（IR）的类风湿关节炎（RA）患者中，托珠单抗（TCZ）作为一线或二线生物治疗药物的疾病活动度和保留率，这是在真实环境下进行的。
在多中心和回顾性背景下，使用患者病历中的数据。在各个时间点评估保留率和 C 反应蛋白（DAS28-CRP）的 28 个关节疾病活动度评分（DAS28-CRP）。还检查了药物疗效与吸烟、肥胖和先前使用 TNFis 等因素的关系。
共纳入 124 例 RA 病程中位数（IQR）为 3.7（7.4）年的患者。平均（SD）年龄为 52.9（12.9）岁，75%的患者为女性。第 6 个月和第 12 个月时 TCZ 的保留率分别为 94.1%和 86.6%。在所有患者中，DAS28-CRP 水平从基线到第 3 个月和第 6 个月显著下降。在第 3 个月和第 6 个月时，缓解和/或低疾病活动度的患者比例增加，而高疾病活动度的患者比例下降（均<0.001）。在任何时间点，基于体重指数、吸烟状况和先前使用 TNFis 的亚组之间，疾病活动度相似。回归分析显示，第 6 个月时，无伴随皮质类固醇治疗与缓解/低疾病活动度的疗效独立相关[比值比（OR）=0.31，95%置信区间（CI）（0.14-0.72），p=0.006]，第 12 个月时，与缓解/低疾病活动度的疗效独立相关[OR=0.35，95%CI（0.13-0.94），p=0.037]。总体而言，报告了 25 例轻度不良事件。
TCZ 对 csDMARDs 和/或 TNFis 治疗反应不足的 RA 患者有效且安全。药物保留率被认为是令人满意的，超过一半的患者在第 12 个月时继续接受 TCZ 治疗。
