类风湿因子对类风湿关节炎患者肿瘤坏死因子抑制剂治疗疗效的影响。
Influence of Rheumatoid Factors on the Efficacy of TNF Inhibitor Therapy in Patients with Rheumatoid Arthritis.
作者信息
Nagayasu Atsushi, Miyazaki Yusuke, Sonomoto Koshiro, Kubo Satoshi, Miyagawa Ippei, Yamaguchi Ayako, Tanaka Hiroaki, Todoroki Yasuyuki, Ueno Masanobu, Aritomi Takafumi, Fujita Yuya, Sakai Hidenori, Suzuki Katsunori, Nakayamada Shingo, Tanaka Yoshiya
机构信息
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Kitakyushu, Fukuoka, 807-8555, Japan.
Department of Infectious Disease Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.
出版信息
Rheumatol Ther. 2025 May 16. doi: 10.1007/s40744-025-00769-3.
INTRODUCTION
Although the efficacy of tumor necrosis factor inhibitors (TNFi) is reduced in patients with rheumatoid factor (RF)-high rheumatoid arthritis (RA), certolizumab pegol (CZP), lacking the Fc portion, may not be affected. This study aimed to compare CZP with Fc-containing TNFi and investigate whether RF levels affect the efficacy of CZP in patients with RA.
METHODS
This multicenter retrospective study involved patients with RA (n = 1010) who received TNFi with concomitant methotrexate (MTX). Patients were categorized by baseline RF quartiles. The primary endpoint was the Simplified Disease Activity Index (SDAI) remission rates at 26 weeks for patients treated with CZP and those receiving Fc-containing TNFi. The secondary endpoint compared the efficacy of CZP and adalimumab (ADA) in each RF quartile using propensity score-based inverse probability of treatment weighting (PS-IPTW).
RESULTS
In the overall cohort, the SDAI remission rate was the lowest in Q4 (RF ≥ 136.45 IU/mL). In Q4, multivariable logistic regression analysis showed that only the introduction of CZP was significantly associated with remission at 26 weeks. The Fc-containing TNFi group had significantly lower SDAI remission rates in Q4 compared with Q1-Q3. Conversely, the SDAI remission rates were similar between the two groups treated with CZP. After PS-IPTW adjustment in Q4, CZP-treated patients showed a significantly lower SDAI and higher remission rate (36.6%) compared with the ADA-treated patients (24.5%) (p = 0.0172). No significant differences in SDAI remission rates were observed between the two groups in Q1-Q3.
CONCLUSION
CZP may be more effective than Fc‑containing TNFi in patients with RA and high RF levels.
引言
尽管肿瘤坏死因子抑制剂（TNFi）在类风湿因子（RF）高的类风湿关节炎（RA）患者中的疗效降低，但不含Fc部分的赛妥珠单抗（CZP）可能不受影响。本研究旨在比较CZP与含Fc的TNFi，并调查RF水平是否影响RA患者中CZP的疗效。
方法
这项多中心回顾性研究纳入了接受TNFi联合甲氨蝶呤（MTX）治疗的RA患者（n = 1010）。患者按基线RF四分位数进行分类。主要终点是接受CZP治疗的患者和接受含Fc的TNFi治疗的患者在26周时的简化疾病活动指数（SDAI）缓解率。次要终点是使用基于倾向评分的治疗加权逆概率（PS-IPTW）比较每个RF四分位数中CZP和阿达木单抗（ADA）的疗效。
结果
在整个队列中，Q4（RF≥136.45 IU/mL）的SDAI缓解率最低。在Q4中，多变量逻辑回归分析显示，仅引入CZP与26周时的缓解显著相关。与Q1-Q3相比，含Fc的TNFi组在Q4中的SDAI缓解率显著更低。相反，接受CZP治疗的两组之间的SDAI缓解率相似。在Q4进行PS-IPTW调整后，与接受ADA治疗的患者（24.5%）相比，接受CZP治疗的患者的SDAI显著更低，缓解率更高（36.6%）（p = 0.0172）。在Q1-Q3中，两组之间未观察到SDAI缓解率的显著差异。
结论
在RF水平高的RA患者中，CZP可能比含Fc的TNFi更有效。
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