Sonomoto Koshiro, Nakayamada Shingo, Tanaka Hiroaki, Nagayasu Atsushi, Tanaka Yoshiya
Department of Clinical Nursing, School of Health Sciences, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Rheumatol Ther. 2025 Jun;12(3):561-580. doi: 10.1007/s40744-025-00762-w. Epub 2025 Apr 21.
This work aims to illustrate the evolution and ongoing challenges of rheumatoid arthritis (RA) management with targeted therapy over 20 years, using a cohort study from the world's oldest society.
Data were obtained from FIRST registry, a multicenter cohort of patients with RA treated with biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Patients were followed for 60 months and assessed for drug efficacy, retention, and reasons for discontinuation.
Analysis of 5130 treatments over 16,616 person-years revealed shifts in strategies and demographics. Despite an aging population (51.9-64.3 years) with increasing comorbidities (lung disease: 11.1-36.2%, malignancy: 2.2-13.1%), b/tsDMARD use expanded to include patients with lower disease activity. With better disease control, discontinuations due to adverse events decreased, and particularly infections fell from 2.1 to 0.7 per 100 person-years. Remission rates improved over time in the naïve group but remained largely unchanged in the prior b/tsDMARDs group. Retention rates varied by bDMARD class, with TNF inhibitors (TNFi) showing a decrease over time and IL-6 receptor inhibitors (IL-6Ri) and CTLA4-Ig showing an increase in retention. TNFi had high remission rates but low retention, whereas CTLA4-Ig and IL-6Ri had lower remission rates and higher retention. Changes in functional improvement were modest overall, and in patients aged 75 years and older, functional gains remained limited.
The study highlights the evolving landscape of RA management in an aging society, noting gains in efficacy and safety. However, unmet needs persist, particularly for patients not fully achieving treat-to-target goals and those with limited functional improvement.
本研究旨在通过一项来自世界上最古老协会的队列研究,阐述过去20年中类风湿关节炎(RA)靶向治疗的演变及持续面临的挑战。
数据来自FIRST注册研究,这是一个多中心队列研究,纳入了接受生物制剂/靶向合成改善病情抗风湿药物(b/tsDMARDs)治疗的RA患者。对患者进行60个月的随访,并评估药物疗效、留存率及停药原因。
对16616人年中的5130次治疗进行分析,发现治疗策略和人口统计学特征发生了变化。尽管人群老龄化(51.9 - 64.3岁)且合并症增多(肺部疾病:11.1% - 36.2%,恶性肿瘤:2.2% - 13.1%),但b/tsDMARDs的使用范围扩大至疾病活动度较低的患者。随着疾病控制改善,因不良事件导致的停药减少,尤其是感染率从每100人年2.1次降至0.7次。初治组的缓解率随时间有所提高,但既往使用过b/tsDMARDs的组基本保持不变。不同bDMARD类别的留存率有所不同,肿瘤坏死因子抑制剂(TNFi)随时间呈下降趋势,而白细胞介素 - 6受体抑制剂(IL - 6Ri)和CTLA4 - Ig的留存率呈上升趋势。TNFi缓解率高但留存率低,而CTLA4 - Ig和IL - 6Ri缓解率较低但留存率较高。总体功能改善变化不大,在75岁及以上患者中,功能改善仍然有限。
该研究凸显了老龄化社会中RA管理格局的演变,指出了疗效和安全性方面的进展。然而,未满足的需求依然存在,尤其是对于未完全实现治疗目标的患者以及功能改善有限的患者。