Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 120-1 Neungdong-Ro, Gwangjin-Gu, Seoul, Republic of Korea.
Division of Rheumatology, Department of Internal Medicine, Research Institute of Medical Science, Konkuk University Medical Center, Konkuk University School of Medicine, 120-1 Neungdong-Ro, Gwangjin-Gu, Seoul, Republic of Korea.
Sci Rep. 2022 Nov 19;12(1):19951. doi: 10.1038/s41598-022-24027-6.
The present study evaluated the predictive role of baseline radiographic change and disease activity on drug retention and clinical response in patients with rheumatoid arthritis (RA) treated with tumor necrosis factor inhibitor (TNFi). Korean Observational Study Network for Arthritis (KORONA) registry was evaluated to identify RA patients treated with a TNFi. Disease activity score-28 (DAS28) was evaluated at baseline and 1 year after TNFi initiation or at termination of TNFi due to inefficacy (within 1 year). The retention rate of TNFi was compared in patients with and without bony erosions. The hazard ratio (HR) for drug retention was evaluated by Cox regression analysis, as was the odds ratio (OR) for achieving remission (DAS28 < 2.6). This study included 109 RA patients, including 97 (89%) women and 30 (27.5%) with erosions, who were treated with a TNFi. Higher baseline DAS28 was negatively associated with achievement of remission (OR = 0.56, 95% CI 0.35-0.88). The TNFi retention rate was significantly lower in RA patients with than in those without erosions (p = 0.04). Factors significantly associated with drug discontinuation included the presence of erosions (HR = 2.45, 95% CI 1.08-5.51) and higher time-averaged DAS28 (HR = 2.17, 95% CI 1.47-3.20), whereas concomitant methotrexate was associated with lack of drug discontinuation (HR = 0.40, 95% CI 0.17-0.95). The presence of erosions and high time-averaged disease activity could predict poor retention of TNFi by RA patients. Higher baseline DAS28 was associated with a reduced clinical response in patients with RA.Trial registration Clinical Research Information Service of South Korea https://cris.nih.go.kr : KCT0000086, registered May 26, 2009.
本研究评估了基线放射学改变和疾病活动度对接受肿瘤坏死因子抑制剂 (TNFi) 治疗的类风湿关节炎 (RA) 患者药物保留和临床反应的预测作用。评估了韩国关节炎观察研究网络 (KORONA) 登记处，以确定接受 TNFi 治疗的 RA 患者。在开始 TNFi 治疗或因疗效不佳 (1 年内) 终止 TNFi 治疗时，评估疾病活动评分-28 (DAS28)。比较有和无骨侵蚀的患者 TNFi 的保留率。通过 Cox 回归分析评估药物保留的风险比 (HR)，并评估达到缓解 (DAS28<2.6) 的比值比 (OR)。这项研究包括 109 名 RA 患者，其中 97(89%)为女性，30(27.5%)有侵蚀，他们接受了 TNFi 治疗。较高的基线 DAS28 与达到缓解呈负相关 (OR=0.56,95%CI 0.35-0.88)。有侵蚀的 RA 患者的 TNFi 保留率明显低于无侵蚀的患者 (p=0.04)。与药物停药显著相关的因素包括存在侵蚀 (HR=2.45,95%CI 1.08-5.51) 和较高的平均时间 DAS28 (HR=2.17,95%CI 1.47-3.20)，而同时使用甲氨蝶呤与药物停药无关 (HR=0.40,95%CI 0.17-0.95)。侵蚀的存在和高平均疾病活动度可能预测 RA 患者 TNFi 的保留率较差。较高的基线 DAS28 与 RA 患者的临床反应降低相关。
试验注册 韩国临床研究信息服务 https://cris.nih.go.kr: KCT0000086，于 2009 年 5 月 26 日注册。
