Division of Rheumatology, Department of Internal Medicine, Hacettepe University Faculty of Medicine, Ankara, Turkey.
Division of Rheumatology, Department of Internal Medicine, Bursa Uludag University Faculty of Medicine, Health Application and Research Center, Bursa, Turkey.
Clin Exp Rheumatol. 2024 Jan;42(1):130-137. doi: 10.55563/clinexprheumatol/2h6ma1. Epub 2023 Aug 29.
To evaluate the retention rate, treatment response and safety of tocilizumab (TCZ) as first-line biologic treatment in rheumatoid arthritis (RA) patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR).
The TReasure Registry is a multicentre, web-based registry of RA and spondyloarthritis patients across Turkey. DMARD-IR RA patients who received TCZ as first-line biologic treatment were included in this registry for efficacy and safety. Demographic and clinical data, treatments, and adverse events were collected. Drug retention rate was estimated using Kaplan-Meier analysis.
Among 642 RA patients who ever used TCZ, 258 DMARD-IR RA patients (male/female: 18.2%/81.8%, mean age, 54.41 years) received TCZ as first-line biologic. The median disease duration was 97 (range, 60-179) months and the median TCZ treatment duration was 15 (range, 6-28) months. At the 6th and 12th months of TCZ treatment, the decrease in disease activity scores from baseline was significant. The Kaplan-Meier analysis revealed the retention rate of TCZ at the 12th, 24th, 36th, and 60th months as 81.1%, 73.8%, 66.2%, and 63.6%, respectively. Fifty-seven (22%) patients discontinued TCZ; the main reason being primary or secondary inefficacy (n=29).
Over 80% drug retention rate at 12th month of TCZ treatment in this real-world study was concordant with previously conducted TCZ clinical studies. Significant reductions not only in the disease activity score-28 but also in the simplified disease activity index (SDAI) and clinical disease activity index (CDAI) scores, along with health assessment questionnaire (HAQ) scores, supported the impact of TCZ in RA management with a good safety profile.
评估托珠单抗（TCZ）作为生物一线治疗药物，在对疾病修饰抗风湿药物（DMARD-IR）反应不足的类风湿关节炎（RA）患者中的保留率、治疗反应和安全性。
TReasure 登记研究是一项在土耳其进行的多中心、基于网络的 RA 和脊柱关节炎患者登记研究。该登记研究纳入了接受 TCZ 作为一线生物治疗药物的 DMARD-IR RA 患者，以评估其疗效和安全性。收集了人口统计学和临床数据、治疗方法和不良反应。采用 Kaplan-Meier 分析估计药物保留率。
在曾使用 TCZ 的 642 例 RA 患者中，258 例 DMARD-IR RA 患者（男/女：18.2%/81.8%，平均年龄 54.41 岁）接受 TCZ 作为一线生物治疗药物。中位疾病病程为 97（范围 60-179）个月，TCZ 治疗中位时间为 15（范围 6-28）个月。在 TCZ 治疗的第 6 个月和第 12 个月，疾病活动评分从基线的下降具有显著意义。Kaplan-Meier 分析显示，TCZ 在第 12、24、36 和 60 个月的保留率分别为 81.1%、73.8%、66.2%和 63.6%。57（22%）例患者停用 TCZ，主要原因为原发性或继发性疗效不佳（n=29）。
本真实世界研究中，TCZ 治疗 12 个月的药物保留率超过 80%，与之前的 TCZ 临床研究结果一致。不仅在疾病活动评分-28 方面，而且在简化疾病活动指数（SDAI）和临床疾病活动指数（CDAI）评分以及健康评估问卷（HAQ）评分方面都有显著降低，支持 TCZ 在 RA 管理中的作用，且具有良好的安全性。
