Objectives To compare the efficacy to prevent flares of maintenance versus withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease. Methods A monocentric, 12-month, superiority, open-label, randomised (1:1) controlled trial was conducted with 61 patients continuing 5 mg/day prednisone and 63 stopping it. Eligibility criteria were SLE patients who, during the year preceding the inclusion, had a clinically inactive disease and a stable SLE treatment including 5 mg/day prednisone. The primary endpoint was the proportion of patient experiencing a flare defined with the SELENA-SLEDAI flare index (SFI) at 52 weeks. Secondary endpoints included time to flare, flare severity according to SFI and British Isles Lupus Assessment Group (BILAG) index and increase in the Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI). Results Proportion of patients experiencing a flare was significantly lower in the maintenance group as compared with the withdrawal group (4 patients vs 17; RR 0.2 (95% CI 0.1 to 0.7), p=0.003). Maintenance of 5 mg prednisone was superior with respect to time to first flare (HR 0.2; 95% CI 0.1 to 0.6, p=0.002), occurrence of mild/moderate flares using the SFI (3 patients vs 12; RR 0.2 (95% CI 0.1 to 0.8), p=0.012) and occurrence of moderate/severe flares using the BILAG index (1 patient vs 8; RR 0.1 (95% CI 0.1 to 0.9), p=0.013). SDI increase and adverse events were similar in the two treatment groups. Subgroup analyses of the primary endpoint by predefined baseline characteristics did not show evidence of a different clinical response. Conclusion Maintenance of long term 5 mg prednisone in SLE patients with inactive disease prevents relapse. Trial registration number NCT02558517; Results

中文翻译：

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临床静止期超过 1 年的 SLE 患者停用低剂量强的松：一项随机临床试验

目的 比较临床静止期系统性红斑狼疮 (SLE) 患者预防维持和停用 5 mg/天泼尼松的疗效。方法 一项单中心、12 个月、优效性、开放标签、随机 (1:1) 对照试验对 61 名患者继续 5 mg/天泼尼松和 63 名停止使用进行。合格标准是在纳入前一年内患有临床非活动性疾病和稳定的 SLE 治疗（包括 5 mg/天泼尼松）的 SLE 患者。主要终点是在 52 周时经历由 SELENA-SLEDAI 耀斑指数 (SFI) 定义的耀斑的患者比例。次要终点包括发作时间，根据 SFI 和不列颠群岛狼疮评估组 (BILAG) 指数和系统性狼疮国际合作诊所 (SLICC) 损伤指数 (SDI) 增加的耀斑严重程度。结果 与停药组相比，维持组中出现发作的患者比例显着降低（4 例对 17 例；RR 0.2（95% CI 0.1 至 0.7），p=0.003）。在首次发作时间（HR 0.2；95% CI 0.1 至 0.6，p=0.002）、使用 SFI 发生轻度/中度发作（3 名患者对 12 名患者；RR 0.2（95% CI 0.1 至 0.8），p=0.012）和使用 BILAG 指数发生中/重度发作（1 名患者对 8 名患者；RR 0.1（95% CI 0.1 至 0.9），p=0.013）。两个治疗组的 SDI 增加和不良事件相似。通过预定义的基线特征对主要终点的亚组分析未显示不同临床反应的证据。结论 非活动性疾病 SLE 患者长期维持 5 mg 泼尼松可防止复发。试用注册号NCT02558517；结果