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患有合并症预测早期类风湿关节炎尽管进行强化治疗但预后更差:实用随机对照 CareRA 试验的事后评估。

Having a co-morbidity predicts worse outcome in early rheumatoid arthritis despite intensive treatment: a post hoc evaluation of the pragmatic randomized controlled CareRA trial.

机构信息

KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, Leuven, Belgium.

Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.

出版信息

Rheumatology (Oxford). 2021 Aug 2;60(8):3699-3708. doi: 10.1093/rheumatology/keaa841.

DOI:10.1093/rheumatology/keaa841
PMID:33434277
Abstract

OBJECTIVES

To quantify the prevalence of co-morbidities in patients with early RA and determine their prognostic value for effectiveness outcomes in a randomized trial.

METHODS

We included patients from the 2-year pragmatic randomized CareRA trial, who had early RA (diagnosis < 1 year), were DMARD naïve and then treated-to-target with different remission induction schemes. Prevalence of co-morbidities was registered at baseline and the Rheumatic Diseases Comorbidity Index (RDCI; range 0-9) was calculated. We tested the relation between baseline RDCI and outcomes including disease activity (DAS28-CRP), physical function (HAQ index), quality of life (SF-36 domains) and hospitalizations over 2 years, using linear mixed models or generalized estimating equations models.

RESULTS

Of 379 included patients, 167 (44%) had a RDCI of minimum 1. RDCI scores of 1, 2 or ≥3 were obtained in 65 (17%), 70 (19%), and 32 (8%) participants, respectively. The most frequent co-morbidity was hypertension (22%). Patients with co-morbidities had significantly higher HAQ (β = 0.215; 95% CI: 0.071, 0.358), DAS28-CRP (β = 0.225; 95% CI: 0.132, 0.319) and lower SF-36 physical component summary scores (β =-3.195; 95% CI: -4.844, -1.546) over 2 years than patients without co-morbidities, after adjusting for possible confounders including disease activity and randomized treatment. Patients with co-morbidities had over time lower chances of achieving remission (OR = 0.724; 95% CI: 0.604, 0.867) and a higher risk of hospitalization (OR = 3.725; 95% CI: 2.136, 6.494).

CONCLUSION

At disease onset, almost half of RA patients had at least one clinically important co-morbidity. Having co-morbidities was associated with worse functionality and disease activity outcomes over 2 years, despite intensive remission induction treatment.

TRIAL REGISTRATION

Clinical trials NCT01172639.

摘要

目的

定量评估早期类风湿关节炎(RA)患者共病的患病率,并确定其在一项随机试验中对有效性结局的预后价值。

方法

我们纳入了来自为期 2 年的实用随机 CareRA 试验的患者,这些患者具有早期 RA(诊断时间<1 年)、未接受过 DMARD 治疗,随后根据不同的缓解诱导方案进行达标治疗。在基线时记录共病的患病率,并计算风湿病共病指数(RDCI;范围 0-9)。我们使用线性混合模型或广义估计方程模型,检测基线 RDCI 与包括疾病活动度(DAS28-CRP)、身体功能(HAQ 指数)、生活质量(SF-36 各维度)和 2 年内住院治疗情况在内的结局之间的关系。

结果

在纳入的 379 例患者中,有 167 例(44%)RDCI 至少为 1。65 例(17%)、70 例(19%)和 32 例(8%)患者的 RDCI 评分分别为 1、2 和≥3。最常见的共病是高血压(22%)。有共病的患者在 2 年内的 HAQ(β=0.215;95%CI:0.071,0.358)、DAS28-CRP(β=0.225;95%CI:0.132,0.319)和 SF-36 身体成分综合评分(β=-3.195;95%CI:-4.844,-1.546)均显著更高,而调整疾病活动度和随机治疗等可能的混杂因素后,无共病的患者在这几个方面的评分均显著更低。有共病的患者随着时间的推移,实现缓解的几率更低(OR=0.724;95%CI:0.604,0.867),住院的风险更高(OR=3.725;95%CI:2.136,6.494)。

结论

在发病时,近一半的 RA 患者至少有一种具有临床重要意义的共病。尽管进行了强化缓解诱导治疗,但存在共病与 2 年内功能和疾病活动度结局更差相关。

试验注册

Clinical trials NCT01172639。

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