Department of Internal Medicine, CHU Montpellier, Montpellier University, Montpellier, France.
PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France.
Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.
To explore the 10-year tolerability profile of glucocorticoids (GC) use in patients with early RA.
Analysis of 10-year outcome from the early arthritis ESPOIR cohort. Patients were stratified in two groups, without or with GC treatment at least once during their follow-up. The primary outcome was a composite of deaths, cardiovascular diseases (CVD), severe infections and fractures. The weighted Cox time-dependent analysis model was used with inverse probability of treatment weighting (IPTW) propensity score method.
Among the 608 patients [480 women, mean age of 47.5 (12.1) years], 397 (65%) received low-dose GC [median 1.9 mg/day (IQR 0.6-4.2), mean cumulative prednisone dose 8468 mg (8376), mean duration 44.6 months (40.1)]. In univariate analysis, over 95 total events (10 deaths, 18 CVDs, 32 fractures and 35 severe infections), patients taking GC experienced more events (n = 71) than those without GC (n = 24) (P =0.035). Highest cumulative exposure of GC (≥8.4 g) was associated with highest risk of occurrence of the primary outcome (24.3%, P =0.007), CVDs (7.9%, P =0.001) and severe infections (9.9%, P =0.024). The risk of events over time was significantly associated with GC, age, hypertension and ESR. The risk associated with GC treatment increased between the first follow-up visit [hazard ratio (HR) at 1 year = 0.46, 95% CI: 0.23, 0.90] and 10 years (HR = 6.83, 95% CI: 2.29, 20.35).
The 10-year analysis of this prospective early RA cohort supports a dose and time-dependent impact of low-dose GC treatment, with a long-term high risk of severe outcomes.
(ClinicalTrials.gov Identifier: NCT03666091).
探讨早期类风湿关节炎患者糖皮质激素（GC）使用 10 年的耐受性情况。
对早期关节炎 ESPOIR 队列的 10 年结果进行分析。患者分为两组，一组在随访期间至少接受过一次 GC 治疗，另一组未接受过 GC 治疗。主要结局是死亡、心血管疾病（CVD）、严重感染和骨折的复合事件。采用逆概率治疗加权（IPTW）倾向评分法的加权 Cox 时间依赖性分析模型。
在 608 名患者中[480 名女性，平均年龄 47.5±12.1 岁]，397 名（65%）接受了低剂量 GC 治疗[中位数 1.9mg/天（IQR 0.6-4.2），平均累积泼尼松剂量 8468mg（8376），平均持续时间 44.6 个月（40.1）]。在单变量分析中，接受 GC 治疗的患者（n=71）比未接受 GC 治疗的患者（n=24）经历了更多的总事件（10 例死亡，18 例 CVD，32 例骨折和 35 例严重感染）（P=0.035）。GC 累积暴露量最高（≥8.4g）与主要结局（24.3%，P=0.007）、CVD（7.9%，P=0.001）和严重感染（9.9%，P=0.024）的发生风险最高相关。随着时间的推移，事件发生的风险与 GC、年龄、高血压和 ESR 显著相关。GC 治疗相关风险在首次随访时[1 年时的 HR=0.46（95%CI：0.23，0.90）]和 10 年时[HR=6.83（95%CI：2.29，20.35）]显著增加。
对前瞻性早期 RA 队列的 10 年分析支持低剂量 GC 治疗存在剂量和时间依赖性影响，长期严重结局风险较高。
（ClinicalTrials.gov 标识符：NCT03666091）。
