日本类风湿关节炎患者的恶性肿瘤发病率及其与生物改性抗风湿药物的关系：来自 IORRA 患者登记处的时间依赖性分析。

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-07-17 DOI:10.1007/s40744-024-00689-8

Masayoshi Harigai, Eiichi Tanaka, Eisuke Inoue, Ryoko Sakai, Naohiro Sugitani, Shigeyuki Toyoizumi, Naonobu Sugiyama, Hisashi Yamanaka

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引用次数: 0

摘要

导言：与普通人群相比，类风湿性关节炎（RA）患者患恶性肿瘤的风险可能会增加，而使用生物改良抗风湿药（bDMARD）可能会增加这种风险。利用患者登记数据，我们确定了日本 RA 患者与日本普通人群的恶性肿瘤风险，并根据 bDMARD 的使用情况进行了分层，同时研究了 bDMARD 的使用是否是恶性肿瘤发病的时间依赖性风险因素：在 IORRA（类风湿关节炎风湿病学研究所）患者登记册中，年龄≥ 18 岁且有≥ 2 项 RA 数据的患者被识别出来（"所有 RA "队列），登记时间为 2013 年 1 月至 2018 年 12 月。患者被分层为bDMARD（接受过≥1次bDMARD）或非bDMARD（无bDMARD使用史）亚队列。计算了恶性肿瘤发病率和标准化发病率比（SIR）以及与日本普通人群的 95% 置信区间（CI）。在对协变量进行调整后，使用时间依赖性 Cox 比例危险模型对使用 RA 药物的风险进行了分析：所有RA队列中共有8020名患者；bDMARD和非bDMARD子队列分别有2187名和5833名患者。在所有三个队列中，总体恶性肿瘤发病率与日本普通人群相似。特定恶性肿瘤的发病率也相似，但所有三个队列中淋巴瘤的发病率较高（SIRs [95% CIs] 分别为 3.72 [2.71-4.93]、5.97 [3.34-9.59]和 2.79 [1.82-4.02]）。在 bDMARD 亚队列中，未观察到其他部位特异性恶性肿瘤的 SIRs 增加。在所有RA队列中，使用甲氨蝶呤、他克莫司、糖皮质激素、非甾体抗炎药和bDMARDs与总体恶性肿瘤风险无关；使用bDMARDs的危险比（95% CI）为1.36（0.96-1.93）。疾病活动性增加是一个与时间相关的总体恶性肿瘤风险因素，其危险比（95% CI）为1.35（1.15-1.59）：结论：使用bDMARDs并非恶性肿瘤的时间依赖性风险因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry.

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Introduction: Patients with rheumatoid arthritis (RA) may have an increased malignancy risk versus the general population, potentially elevated by biological disease-modifying antirheumatic drug (bDMARD) use. Using patient registry data, we determined malignancy risk, stratified by bDMARD use, among Japanese patients with RA versus the Japanese general population and investigated whether bDMARD use is a time-dependent risk factor for the development of malignancy.

Methods: Patients aged ≥ 18 years with ≥ 2 data entries of RA in the IORRA (Institute of Rheumatology, Rheumatoid Arthritis) patient registry, enrolled from January 2013-December 2018, were identified ('All RA' cohort). Patients were stratified into bDMARD (≥ 1 bDMARD received) or non-bDMARD (no history of bDMARDs) sub-cohorts. Malignancy incidence rates and standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) versus the Japanese general population were calculated. Risk of RA medication use was analyzed using a time-dependent Cox proportional hazards model, after adjusting for covariates.

Results: A total of 8020 patients were identified for the All RA cohort; 2187 and 5833 for the bDMARD and non-bDMARD sub-cohorts, respectively. For all three cohorts, incidence of overall malignancies was similar versus the Japanese general population. Incidence of specific malignancies was also similar, but incidence of lymphoma was higher for all three cohorts (SIRs [95% CIs] 3.72 [2.71-4.93], 5.97 [3.34-9.59], and 2.79 [1.82-4.02], respectively). In the bDMARD sub-cohort, no increase in SIRs was observed for other site-specific malignancies. In the All RA cohort, use of methotrexate, tacrolimus, glucocorticoids, non-steroidal anti-inflammatory drugs, and bDMARDs were not associated with the risk of overall malignancy; the hazard ratio (95% CI) was 1.36 (0.96-1.93) for bDMARD use. Increased disease activity was a time-dependent risk factor of overall malignancy with a hazard ratio (95% CI) of 1.35 (1.15-1.59).

Conclusions: The use of bDMARDs was not a time-dependent risk factor for malignancy.

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

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