日本类风湿关节炎患者使用生物性改善病情抗风湿药和 Janus 激酶抑制剂的治疗模式：一项基于索赔数据的队列研究
Treatment Patterns of Biologic Disease-Modifying Antirheumatic Drugs and Janus Kinase Inhibitors in Patients with Rheumatoid Arthritis in Japan: A Claims-Based Cohort Study.
作者信息
Miyashiro Masahiko, Asano Teita, Ishii Yutaka, Miyazaki Celine, Shimizu Hirohito, Masuda Junya
机构信息
Immunology and Infectious Diseases Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Nishi Kanda 3-5-2, Chiyoda-Ku, Tokyo, 101-0065, Japan.
Value, Evidence and Access Department, Janssen Pharmaceutical K.K., Nishi Kanda 3-5-2, Chiyoda-Ku, Tokyo, 101-0065, Japan.
出版信息
Drugs Real World Outcomes. 2024 Jun;11(2):285-297. doi: 10.1007/s40801-024-00423-4. Epub 2024 Apr 10.
BACKGROUND
Reports on treatment patterns of biologic disease-modifying antirheumatic drugs (bDMARDs)/Janus kinase inhibitors (JAKi) for rheumatoid arthritis (RA) in clinical practice are still sparse in Japan, especially in combination with conventional synthetic DMARDs (csDMARDs).
OBJECTIVES
The aim of this study was to investigate treatment patterns of bDMARD/JAKi in the treatment of RA in real-world clinical practice in Japan.
METHOD
A retrospective cohort study was conducted using the Japanese Medical Data Vision health claims database. The inclusion criteria required a recorded diagnosis of RA, defined by ICD-10 codes, in patients aged 18 years and older on the index date. We analyzed 39,903 RA patients treated with DMARDs from 2008 to 2020.
RESULTS
Among analyzed subjects, 10,196 patients (25.6%) were prescribed bDMARDs/JAKi in combination with csDMARDs, and 3067 patients (7.7%) were prescribed these drugs without csDMARDs. Among the bDMARDs/JAKi, tumor necrosis factor inhibitors (TNFi) were the most commonly prescribed DMARD overall, and also the most common first-line therapy, accounting for 60.0% or 45.5% of patients prescribed these drugs in combination with or without csDMARDs, respectively. Switching, temporary discontinuation (restarting with the same agents), and discontinuation of bDMARDs/JAKi were observed in 3150 (30.9%), 1379 (13.5%), and 2025 (19.9%) patients with csDMARDs, and in 849 (27.7%), 513 (16.7%), and 833 (27.2%) patients without csDMARDs, respectively.
CONCLUSIONS
Real-world treatment trajectories of bDMARDs/JAKi with and without csDMARDs was analyzed in RA patients in Japan between 2008 and 2020. TNFi were the predominant first-line therapy, and likely to be switched to different classes. Understanding the current treatment patterns, including discontinuation, is important to find an optimal treatment strategy for RA patients.
背景
在日本，关于生物性改善病情抗风湿药物（bDMARDs）/Janus激酶抑制剂（JAKi）用于类风湿关节炎（RA）临床治疗模式的报告仍然很少，尤其是与传统合成DMARDs（csDMARDs）联合使用的情况。
目的
本研究旨在调查在日本实际临床实践中bDMARD/JAKi治疗RA的模式。
方法
使用日本医疗数据视觉健康保险索赔数据库进行一项回顾性队列研究。纳入标准要求在索引日期时年龄在18岁及以上的患者，根据ICD-10编码记录有RA诊断。我们分析了2008年至2020年期间接受DMARDs治疗的39903例RA患者。
结果
在分析的受试者中，10196例患者（25.6%）被处方bDMARDs/JAKi联合csDMARDs，3067例患者（7.7%）被处方这些药物但未联合csDMARDs。在bDMARDs/JAKi中，肿瘤坏死因子抑制剂（TNFi）是总体上最常处方的DMARD，也是最常见的一线治疗药物，分别占联合或未联合csDMARDs处方这些药物患者的60.0%或45.5%。在联合csDMARDs的患者中，分别有3150例（30.9%）、1379例（13.5%）和2025例（19.9%）观察到bDMARDs/JAKi的换药、暂时停药（用相同药物重新开始）和停药；在未联合csDMARDs的患者中，分别有849例（27.7%）、513例（16.7%）和833例（27.2%）观察到上述情况。
结论
分析了2008年至2020年期间日本RA患者使用和未使用csDMARDs时bDMARDs/JAKi的实际治疗轨迹。TNFi是主要的一线治疗药物，且可能会换用不同类别药物。了解当前包括停药在内的治疗模式对于为RA患者找到最佳治疗策略很重要。
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