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真实世界中,慢性炎症性关节炎患者采用单药治疗与联合治疗初始靶向治疗策略的持续情况。

Real-world persistence of initial targeted therapy strategy in monotherapy versus combination therapy in patients with chronic inflammatory arthritis.

机构信息

Rheumatology Unit, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.

Health Technology Assessment Agency (AETS), Instituto de Salud Carlos III, Madrid, Spain.

出版信息

Eur J Clin Invest. 2024 Feb;54(2):e14095. doi: 10.1111/eci.14095. Epub 2023 Sep 16.

Abstract

OBJECTIVE

The persistence of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs(DMARDs) in monotherapy versus in combination with conventional synthetic (cs) DMARDs is still a controversial topic in rheumatic diseases. To clarify this issue, the retention of the initial treatment strategy of b/tsDMARD in combination with csDMARD versus monotherapy in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients under real-life conditions was evaluated. Factors associated with maintenance of the initial strategy were analysed.

METHODS

Nested cohort study within the Spanish BIOBADASER III registry. Bivariate comparisons and multivariate Cox proportional hazards models were used for the analyses.

RESULTS

A total of 2521 patients were included in the study. In the multivariate model, the initial strategy of combination therapy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58;95% confidence interval [CI] 1.00-2.50; p = .049), PsA (HR 2.48; 95% CI 1.65-3.72) and AS (HR 16.77; 95% CI 7.37-38.16; p < .001), regardless of sex, time of disease progression, baseline disease activity, glucocorticoid use or type of b/tsDMARD. Overall, the combination strategy was associated with an increased incidence of adverse events (incidence rate ratio [IRR] 1.13; 95% CI 1.05-1.21).

CONCLUSIONS

In this real-life study, the strategy of combining a b/tsDMARD with a csDMARD is associated with lower persistence and worse safety profile compared to monotherapy in RA and especially in PsA and AS, suggesting that combination therapy should be rethought as first choice in RA patients, but especially in PsA and AS patients.

摘要

目的

生物制剂(b)和靶向合成(ts)疾病修饰抗风湿药物(DMARDs)在单药治疗与联合常规合成(cs)DMARDs 治疗中的持续性仍是风湿性疾病中的一个有争议的话题。为了阐明这一问题,评估了在真实环境下类风湿关节炎(RA)、银屑病关节炎(PsA)和强直性脊柱炎(AS)患者中,b/tsDMARD 联合 csDMARD 初始治疗策略相对于单药治疗的保留率,分析了维持初始策略的相关因素。

方法

西班牙 BIOBADASER III 登记处的嵌套队列研究。采用双变量比较和多变量 Cox 比例风险模型进行分析。

结果

共纳入 2521 例患者。在多变量模型中,联合治疗的初始策略与 RA(风险比 [HR] 1.58;95%置信区间 [CI] 1.00-2.50;p=0.049)、PsA(HR 2.48;95% CI 1.65-3.72)和 AS(HR 16.77;95% CI 7.37-38.16;p<0.001)患者的药物持续时间缩短相关,无论性别、疾病进展时间、基线疾病活动度、糖皮质激素使用或 b/tsDMARD 类型如何。总体而言,联合治疗策略与不良反应发生率增加相关(发病率比 [IRR] 1.13;95% CI 1.05-1.21)。

结论

在这项真实世界研究中,与单药治疗相比,b/tsDMARD 联合 csDMARD 的治疗策略在 RA 中,特别是在 PsA 和 AS 中与较低的药物持续性和较差的安全性相关,提示联合治疗策略应重新考虑作为 RA 患者的首选治疗方法,但尤其应考虑作为 PsA 和 AS 患者的首选治疗方法。

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