Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial.

Methods

The Strategies for glucocorticoid TApering in Rheumatoid arthritis (STAR) study was a double- blind, double-placebo randomised controlled trialincluding patients with RA receiving a stable dose of glucocorticoid 5 mg/day for ≥3 months and were in LDA for ≥3 months.

糖皮质激素逐渐减量策略在类风湿性关节炎中的研究（STAR研究）是一项双盲、双安慰剂随机对照试验，包括接受稳定剂量的糖皮质激素（每天5毫克）≥3个月且疾病活动度低（LDA）≥3个月的类风湿性关节炎患者。

Patients were randomly assigned in a 1:1 ratio to either replace prednisone with 20 mg/day of hydrocortisone for 3 months, then reduce to 10 mg/day for 3 months before discontinuation or to taper prednisone by 1 mg/day every month until complete discontinuation, contingent on maintaining LDA.

患者以1:1的比例随机分配，要么用20 mg/天的氢化可的松替代泼尼松治疗3个月，然后减至10 mg/天再持续3个月后停药，要么每月减少1 mg/天的泼尼松剂量直至完全停药，条件是维持低疾病活动度（LDA）状态。

The primary outcome was the percentage of patients achieving glucocorticoid discontinuation at 12 months.

主要结果是12个月内实现糖皮质激素停药的患者百分比。

Other secondary outcomes were proportion of flares, need for additional glucocorticoid use, disease activity, patient-reported outcomes and the results of adrenocorticotropic hormone (ACTH) stimulation tests.

其他次要结果包括发作比例、需要额外使用糖皮质激素、疾病活动度、患者报告的结果以及促肾上腺皮质激素（ACTH）刺激试验的结果。

Results

Of the 102 patients randomised in the trial (mean age 62.4 years, 70.6% females), 53 had hydrocortisone replacement and 49 tapered prednisone.

在试验中随机分配的102名患者（平均年龄62.4岁，70.6%为女性），53人接受了氢化可的松替代治疗，49人逐渐减少泼尼松的用量。

At 12 months, 29 patients (55%) in the hydrocortisone replacement group and 23 patients (47%) in the prednisone tapering group achieved glucocorticoid discontinuation (p=0.4).

在12个月时，29名（55%）接受氢化可的松替代治疗的患者和23名（47%）接受泼尼松逐渐减量治疗的患者实现了糖皮质激素的停药（p=0.4）。

No difference was observed between groups in the secondary outcomes.

两组在次要结果指标上未观察到差异。

No cases of acute adrenal insufficiency were observed; however, 17 patients still had an abnormal ACTH stimulation test at 12 months, with no differences between arms.

未观察到急性肾上腺功能不全的病例；然而，12个月时仍有17名患者的ACTH刺激试验异常，两组之间没有差异。

Conclusions

A hydrocortisone replacement strategy was not superior to a prednisone tapering strategy for achieving glucocorticoid discontinuation success in patients with RA in LDA.

对于处于低疾病活动度（LDA）的类风湿关节炎（RA）患者，使用氢化可的松替代策略并不优于泼尼松逐渐减量策略，以实现糖皮质激素停药的成功。

trial_registration_number

NCT02997605.

NCT02997605。