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生物制剂类改善病情抗风湿药物在老年类风湿关节炎患者中的安全性和有效性:一项前瞻性队列研究。

Safety and Effectiveness of Biologic Disease-Modifying Antirheumatic Drugs in Older Patients with Rheumatoid Arthritis: A Prospective Cohort Study.

机构信息

Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal.

Instituto Português Reumatologia, Lisboa, Portugal.

出版信息

Drugs Aging. 2020 Dec;37(12):899-907. doi: 10.1007/s40266-020-00801-x. Epub 2020 Nov 18.

Abstract

BACKGROUND AND OBJECTIVE

The number of older patients with rheumatoid arthritis is increasing, but data on drug effectiveness and safety in these patients are scarce. This study assessed the effectiveness and safety of biologic disease-modifying antirheumatic drugs in older patients with rheumatoid arthritis.

METHODS

This prospective cohort study was based on data recorded in the Rheumatic Diseases Portuguese Register (Reuma.pt). Treatment persistence, European League Against Rheumatism response at 6 and 12 months, and adverse events were compared between adult (age < 65 years), old (age 65-74 years), and very old (age ≥ 75 years) patients.

RESULTS

In total, 2401 patients were included, of which 379 were old and 83 were very old. Older patients had higher disease activity at baseline (Disease Activity Score 28: 5.5 in adults, 5.7 in old patients, and 6 in very old patients; p = 0.02) and more comorbidities, with patients aged 65-74 years beginning biologic disease-modifying antirheumatic drugs later in the course of rheumatoid arthritis. Treatment persistence was similar in the three patient groups (p = 0.07). The European League Against Rheumatism response rates were comparable in the three groups at 6 months (81.6% of adults, 75.2% of old patients, and 81.8% of very old patients; p = 0.19), and inferior in old patients at 12 months. The proportion of patients who experienced adverse events was also similar in the three groups (21% of adults, 22.5% of old patients, and 22.9% of very old patients; p = 0.76), but the rate of serious adverse events was higher in old patients (1.94/100 patient-years) and very old patients (4.29/100 patient-years) compared with 1.03/100 patient-years in adult patients with rheumatoid arthritis (p < 0.05).

CONCLUSIONS

Adults, old patients, and very old patients with rheumatoid arthritis benefit similarly from biologic disease-modifying antirheumatic drug treatments, although older patients have more active disease at baseline and more comorbidities. However, it is necessary to consider the risk of serious adverse events in older patients when prescribing a biologic.

摘要

背景与目的

类风湿关节炎老年患者人数不断增加,但针对这些患者的药物疗效和安全性数据却很匮乏。本研究旨在评估生物改善病情抗风湿药物治疗老年类风湿关节炎患者的疗效和安全性。

方法

本前瞻性队列研究基于葡萄牙风湿病登记数据库(Reuma.pt)中的数据。比较了成年(年龄<65 岁)、老年(年龄 65-74 岁)和高龄(年龄≥75 岁)患者之间的治疗持续时间、6 个月和 12 个月时的欧洲抗风湿病联盟(EULAR)反应以及不良事件。

结果

共纳入 2401 例患者,其中 379 例为老年患者,83 例为高龄患者。老年患者的基线疾病活动度更高(DAS28:成年患者为 5.5,老年患者为 5.7,高龄患者为 6.0;p=0.02),合并症更多,65-74 岁患者开始接受生物改善病情抗风湿药物治疗的时间较晚。三组患者的治疗持续时间无显著差异(p=0.07)。三组患者在 6 个月时的 EULAR 反应率相当(成年患者为 81.6%,老年患者为 75.2%,高龄患者为 81.8%;p=0.19),但老年患者在 12 个月时的反应率较低。三组患者不良事件的发生率也相似(成年患者为 21%,老年患者为 22.5%,高龄患者为 22.9%;p=0.76),但老年患者(1.94/100 患者年)和高龄患者(4.29/100 患者年)的严重不良事件发生率高于成年患者(1.03/100 患者年;p<0.05)。

结论

接受生物改善病情抗风湿药物治疗的成年、老年和高龄类风湿关节炎患者均能从中获益,尽管老年患者的基线疾病更活跃,合并症更多。但在为老年患者开具生物制剂时,需考虑严重不良事件的风险。

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