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靶向治疗策略在老年发病类风湿关节炎中的疗效和安全性:一项为期 3 年的前瞻性观察研究。

Effectiveness and safety of treat-to-target strategy in elderly-onset rheumatoid arthritis: a 3-year prospective observational study.

机构信息

Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital.

Human Care Research Team, Tokyo Metropolitan Institute of Gerontology.

出版信息

Rheumatology (Oxford). 2021 Sep 1;60(9):4252-4261. doi: 10.1093/rheumatology/keaa922.

DOI:10.1093/rheumatology/keaa922
PMID:33410490
Abstract

OBJECTIVES

To evaluate 3-year outcomes of following a treat-to-target (T2T) strategy targeting low disease activity for patients with elderly-onset RA (EORA) and to confirm safety profile of T2T.

METHODS

Treatment was adjusted to target low disease activity with conventional synthetic DMARDs, followed by biologic DMARDs (bDMARDs) in 197 MTX-naïve EORA patients (mean age 74.9 years) with moderate-to-high disease activity. Non-implementation of T2T was evaluated at week 12, 24, 36, 52, 76, 104 and 128. To evaluate risks of using MTX, bDMARDs and glucocorticoids, 2122 periods of 3 months each were analysed using Bayesian hierarchical logistic regression models.

RESULTS

Of the patients, 84.7% received methotrexate, 34.0% glucocorticoids with DMARDs and 41.6% bDMARDs during the observation period. Sixty-nine of the 197 patients failed to adhere to T2T because of comorbidities or the patient's own decision: 33 failed once, 19 twice, 10 three times and 6 four times or more. Simplified disease activity index (SDAI) remission and HAQ Disability Index (HAQ-DI) ≤0.5 at 3 years were achieved in 57.8% and 70.3% of the 128 patients adhering to T2T, and 34.8% and 43.5% of the 69 patients who did not adhere to T2T, respectively, and these were significantly different. Eighty-nine serious adverse events (SAEs) of any type were reported in 61 patients. MTX, bDMARDs and glucocorticoid were not associated with SAEs when adjusted for mean SDAI during the observation period and comorbidities at baseline.

CONCLUSION

T2T strategy for EORA by using MTX and bDMARDs was effective with an acceptable safety profile. Adhering to T2T led to better outcomes.

摘要

目的

评估针对老年发病类风湿关节炎(EORA)患者采用达标治疗(T2T)策略控制低疾病活动度的 3 年结果,并确认 T2T 的安全性。

方法

197 例初治甲氨蝶呤(MTX)的 EORA 患者(平均年龄 74.9 岁),疾病活动度为中高度,使用传统合成 DMARD 治疗,将疾病活动度调整至低疾病活动度,然后使用生物 DMARD(bDMARD)。在第 12、24、36、52、76、104 和 128 周评估未实施 T2T 的情况。使用贝叶斯层次逻辑回归模型分析 2122 个 3 个月的治疗期,评估 MTX、bDMARD 和糖皮质激素的使用风险。

结果

在观察期间,84.7%的患者接受了甲氨蝶呤,34.0%的患者同时接受了 DMARD 和糖皮质激素治疗,41.6%的患者接受了 bDMARD 治疗。197 例患者中有 69 例因合并症或患者自身决定未遵循 T2T:33 例仅 1 次,19 例 2 次,10 例 3 次,6 例 4 次或更多次。在 128 例坚持 T2T 的患者中,有 57.8%和 70.3%的患者达到了简化疾病活动指数(SDAI)缓解和 HAQ 残疾指数(HAQ-DI)≤0.5,而在 69 例未坚持 T2T 的患者中,分别有 34.8%和 43.5%达到了这一目标,差异具有统计学意义。61 例患者报告了 89 例任何类型的严重不良事件(SAE)。调整观察期间平均 SDAI 和基线合并症后,MTX、bDMARD 和糖皮质激素与 SAE 无关。

结论

使用 MTX 和 bDMARD 对 EORA 采用 T2T 策略是有效的,且具有可接受的安全性。坚持 T2T 可获得更好的结果。

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