Lee Sun-Kyung, Shin Kichul, Jung Ju-Yang, Suh Chang-Hee, Kim Ji-Won, Kim Hyoun-Ah
Department of Mathematics, College of Natural Sciences, Hanyang University, Seoul, Korea.
Division of Rheumatology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
BioDrugs. 2023 Mar;37(2):247-257. doi: 10.1007/s40259-023-00578-6. Epub 2023 Feb 9.
This study aimed to evaluate the long-term retention and safety of biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) and identify the factors associated with drug withdrawal in patients with rheumatoid arthritis (RA) with interstitial lung disease (ILD) enrolled in the Korean College of Rheumatology Biologics and Targeted Therapy registry.
We investigated adults with RA (n = 2266) administered with bDMARDs or tsDMARDs between 2012 and 2021. Propensity score matching (1:3) was performed between patients with RA with ILD (RA-ILD) and without ILD (RA-no ILD). The Kaplan-Meier method was used to analyse drug survival and a logistic regression model to identify withdrawal-related factors in RA-ILD.
One hundred and fifty-nine patients with RA-ILD were matched with 477 patients with RA-no ILD. The 5-year drug retention rate was lower in RA-ILD than in RA-no ILD (log-rank p = 0.020), and both the ILD and no-ILD groups had statistical differences of drug retention rate among agents (log-rank p = 0.019 and 0.020, respectively). In the RA-ILD group, Janus kinase inhibitors had the highest drug retention rate (64.3%), and tumour necrosis factor-α inhibitors showed the lowest retention rate (30.6%). Approximately 58.5% and 48.4% of the patients with RA-ILD and RA-no ILD, respectively, withdrew from their regimen, and the main cause of withdrawal in RA-ILD was adverse events, followed by inefficacy. In the logistic regression analysis, current smoking had a negative effect on drug retention (odds ratio [OR]: 9.938, 95% confidence interval [CI]: 2.550-38.733; p < 0.001), while concomitant corticosteroid use had a protective effect against withdrawal (OR: 0.284, 95% CI: 0.008-0.917; p = 0.035) in RA-ILD.
The patients with RA-ILD had lower bDMARD and tsDMARD retention rates than those with RA-no ILD. In the RA-ILD group, current smoking and concomitant corticosteroid use were associated factors affecting drug withdrawal.
本研究旨在评估生物性抗风湿药物（bDMARDs）和靶向合成抗风湿药物（tsDMARDs）的长期保留率和安全性，并确定韩国风湿病学会生物制剂和靶向治疗登记处登记的类风湿关节炎（RA）合并间质性肺病（ILD）患者停药的相关因素。
我们调查了2012年至2021年间接受bDMARDs或tsDMARDs治疗的成年RA患者（n = 2266）。对RA合并ILD（RA-ILD）患者和无ILD（RA-无ILD）患者进行倾向评分匹配（1:3）。采用Kaplan-Meier法分析药物生存率，并采用逻辑回归模型确定RA-ILD中与停药相关的因素。
159例RA-ILD患者与477例RA-无ILD患者相匹配。RA-ILD患者的5年药物保留率低于RA-无ILD患者（对数秩检验p = 0.020），并且ILD组和无ILD组在不同药物之间的药物保留率均有统计学差异（对数秩检验p分别为0.019和0.020）。在RA-ILD组中，Janus激酶抑制剂的药物保留率最高（64.3%），肿瘤坏死因子-α抑制剂的保留率最低（30.6%）。RA-ILD患者和RA-无ILD患者分别约有58.5%和48.4%退出治疗方案，RA-ILD患者停药的主要原因是不良事件，其次是无效。在逻辑回归分析中，当前吸烟对药物保留有负面影响（比值比[OR]：9.938，95%置信区间[CI]：2.550-38.733；p < 0.001），而在RA-ILD中，同时使用皮质类固醇对停药有保护作用（OR：0.284，95%CI：0.008-0.917；p = 0.035）。
RA-ILD患者的bDMARDs和tsDMARDs保留率低于RA-无ILD患者。在RA-ILD组中，当前吸烟和同时使用皮质类固醇是影响停药的相关因素。
