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戈利木单抗在现实环境中对老年类风湿关节炎合并肾功能不全患者的疗效及安全性

Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting.

作者信息

Yokoyama Seiji, Ishii Yutaka, Masuda Junya

机构信息

Medical Affairs Division, Immunology and Infectious Disease Department, Janssen Pharma K.K., Nishikanda 3-5-2, Chiyoda-ku, Tokyo, 101-0065, Japan.

出版信息

Drugs Real World Outcomes. 2023 Mar;10(1):51-60. doi: 10.1007/s40801-022-00338-y. Epub 2022 Nov 5.

Abstract

BACKGROUND

The efficacy and safety of golimumab in elderly patients with renal dysfunction are not well evaluated due to the exclusion criteria of clinical trials.

OBJECTIVE

To assess the persistence and safety of golimumab in elderly rheumatoid arthritis patients with renal dysfunction.

PATIENTS AND METHODS

In this retrospective observational study, we used Japan's nationwide electronic medical records and claims database to identify patients aged 65 years and older who were newly prescribed golimumab for rheumatoid arthritis between July 2011 and June 2018. Patients were divided into three groups according to estimated glomerular filtration rate (eGFR; high, ≥ 90; moderate, ≥ 60, < 90; low, ≥ 30, < 60), and the persistence of golimumab and adverse events were compared between the groups.

RESULTS

A total of 423 patients met the eligibility criteria. At 6 months, the persistence rates of golimumab were 62.4%, 63.7% and 67.0% in the high, moderate and low eGFR groups, respectively. In Cox proportional hazards regression analysis, baseline eGFR was not associated with golimumab persistence or adverse events, but concomitant methotrexate and low baseline C-reactive protein (CRP) were associated with longer golimumab persistence.

CONCLUSION

Reduced renal function was not associated with continuation of golimumab or incidence of adverse events, suggesting that the persistence of golimumab therapy in patients with rheumatoid arthritis is independent of the baseline level of renal function. On the other hand, concomitant use of methotrexate and low baseline CRP levels were suggested as factors that may affect the persistence of golimumab treatment.

摘要

背景

由于临床试验的排除标准,戈利木单抗在老年肾功能不全患者中的疗效和安全性尚未得到充分评估。

目的

评估戈利木单抗在老年肾功能不全类风湿关节炎患者中的持续用药情况及安全性。

患者与方法

在这项回顾性观察研究中,我们使用日本全国电子病历和理赔数据库,确定2011年7月至2018年6月期间新处方戈利木单抗治疗类风湿关节炎的65岁及以上患者。根据估计肾小球滤过率(eGFR;高,≥90;中,≥60且<90;低,≥30且<60)将患者分为三组,比较各组间戈利木单抗的持续用药情况及不良事件。

结果

共有423例患者符合纳入标准。6个月时,高、中、低eGFR组戈利木单抗的持续用药率分别为62.4%、63.7%和67.0%。在Cox比例风险回归分析中,基线eGFR与戈利木单抗的持续用药情况或不良事件无关,但同时使用甲氨蝶呤和低基线C反应蛋白(CRP)与戈利木单抗更长的持续用药时间相关。

结论

肾功能降低与戈利木单抗的持续使用或不良事件的发生无关,这表明类风湿关节炎患者中戈利木单抗治疗的持续用药情况独立于肾功能的基线水平。另一方面,提示同时使用甲氨蝶呤和低基线CRP水平可能是影响戈利木单抗治疗持续用药情况的因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04e0/9943813/69095d2c870b/40801_2022_338_Fig1_HTML.jpg

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