Ruyssen-Witrand Adeline, Brusq Clara, Masson Maëva, Bongard Vanina, Salliot Carine, Poiroux Lucile, Nguyen Minh, Roux Christian Hubert, Richez Christophe, Saraux Alain, Vergne-Salle Pascale, Morel Jacques, Flipo René-Marc, Piperno Muriel, Gottenberg Jacques-Eric, Marotte Hubert, Soubrier Martin, Gossec Laure, Dieudé Philippe, Lassoued Slim, Zabraniecki Laurent, Couture Guillaume, Boyer Jean Frédéric, Jamard Bénédicte, Degboe Yannick, Constantin Arnaud
Rheumatology Center, Toulouse University Hospital, Toulouse, France; Centre d'Investigation Clinique de Toulouse CIC1436, Inserm, Team PEPSS « Pharmacologie En Population cohorteS et biobanqueS »University of Toulouse 3, Inserm, Toulouse, France.
Research Methodological Support Unit (USMR, Unité de Soutien Méthodologique à la Recherche), Department of Epidemiology and Clinical Research, Toulouse University Hospital, Toulouse, France.
Ann Rheum Dis. 2025 Jan;84(1):49-59. doi: 10.1136/ard-2024-226620. Epub 2025 Jan 2.
To compare two strategies-a hydrocortisone replacement strategy and a prednisone tapering strategy-for their success in glucocorticoid discontinuation in patients with rheumatoid arthritis (RA) with low disease activity (LDA).
The Strategies for glucocorticoid TApering in Rheumatoid arthritis (STAR) study was a double- blind, double-placebo randomised controlled trial including patients with RA receiving a stable dose of glucocorticoid 5 mg/day for ≥3 months and were in LDA for ≥3 months. 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. The primary outcome was the percentage of patients achieving glucocorticoid discontinuation at 12 months. 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.
Of the 102 patients randomised in the trial (mean age 62.4 years, 70.6% females), 53 had hydrocortisone replacement and 49 tapered prednisone. 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). No difference was observed between groups in the secondary outcomes. 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.
A hydrocortisone replacement strategy was not superior to a prednisone tapering strategy for achieving glucocorticoid discontinuation success in patients with RA in LDA.
NCT02997605.
比较两种策略——氢化可的松替代策略和泼尼松逐渐减量策略——在疾病活动度低（LDA）的类风湿关节炎（RA）患者中停用糖皮质激素方面的成功率。
类风湿关节炎糖皮质激素逐渐减量策略（STAR）研究是一项双盲、双安慰剂随机对照试验，纳入了接受稳定剂量5毫克/天糖皮质激素治疗≥3个月且处于LDA状态≥3个月的RA患者。患者按1:1比例随机分配，一组用20毫克/天的氢化可的松替代泼尼松3个月，然后在停药前减至10毫克/天3个月；另一组每月将泼尼松减量1毫克/天直至完全停药，前提是维持LDA状态。主要结局是12个月时实现糖皮质激素停药的患者百分比。其他次要结局包括病情复发比例、额外使用糖皮质激素的需求、疾病活动度、患者报告结局以及促肾上腺皮质激素（ACTH）刺激试验结果。
试验中随机分组的102例患者（平均年龄62.4岁，70.6%为女性），53例接受氢化可的松替代治疗，49例逐渐减量泼尼松。12个月时，氢化可的松替代组29例患者（55%）实现糖皮质激素停药，泼尼松逐渐减量组23例患者（47%）实现停药（p = 0.4）。两组次要结局无差异。未观察到急性肾上腺功能不全病例；然而，12个月时仍有17例患者ACTH刺激试验异常，两组之间无差异。
在LDA的RA患者中，氢化可的松替代策略在实现糖皮质激素停药成功方面并不优于泼尼松逐渐减量策略。
NCT02997605。
