Autoimmune Disease Unit, Internal Medicine Department, Research Institute Vall d'Hebrón Hospital, Barcelona, Spain.
Autoimmune Diseases Unit, Internal Medicine Department, Miguel Servet Hospital, Zaragoza, Spain.
Ann Rheum Dis. 2017 Sep;76(9):1575-1582. doi: 10.1136/annrheumdis-2016-210882. Epub 2017 Apr 27.
To compare the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) versus azathioprine (AZA) in patients with active systemic lupus erythematosus (SLE) disease.
A multicentre, 24-month, superiority, open-label, randomised controlled trial (NCT01112215) was conducted with 240 patients (120 per arm) receiving either EC-MPS (target dose: 1440 mg/day) or AZA (target dose: 2 mg/kg/day) in addition to prednisone and/or antimalarials. The primary endpoint was the proportion of patients achieving clinical remission, assessed by SLE Disease Activity Index 2000 (SLEDAI-2K) and British Isles Lupus Assessment Group (BILAG), at 3 and 24 months. Secondary endpoints included time to clinical remission, BILAG A and B flare rates, time to flare, corticosteroid reduction and adverse events (AEs).
Proportion of patients achieving clinical remission (clinical SLEDAI=0) was higher in the EC-MPS group at 3 (32.5% vs 19.2%; treatment difference, 13.3 (CI 2.3 to 24), p=0.034) and 24 months (71.2% vs 48.3%; treatment difference, 22.9 (CI 10.4 to 34.4), p<0.001). EC-MPS was superior with respect to time to clinical remission (HR 1.43; 95% CI 1.07 to 1.91; p=0.017). BILAG A/B and B flares occurred more frequently in the AZA group (71.7% vs 50%, p=0.001 and 21.67% vs 8.3%, p=0.004, respectively). EC-MPS was superior with respect to time to first BILAG A/B (HR 1.81; 95% CI 1.3 to 2.56; p=0.0004) and BILAG A flare (HR 2.84; 95% CI 1.37 to 5.89; p=0.003). AEs were similar in both groups except for leucopenia that occurred more frequently with AZA.
EC-MPS was superior to AZA in treating SLE and preventing further relapses.
NCT01112215; Results.
比较肠溶性吗替麦考酚酯（EC-MPS）与硫唑嘌呤（AZA）在活动期系统性红斑狼疮（SLE）患者中的疗效和安全性。
一项多中心、24 个月、优效性、开放标签、随机对照试验（NCT01112215）纳入 240 例患者（每组 120 例），在接受泼尼松和/或抗疟药治疗的基础上，分别给予 EC-MPS（目标剂量：1440mg/天）或 AZA（目标剂量：2mg/kg/天）。主要终点为 SLE 疾病活动指数 2000 （SLEDAI-2K）和不列颠群岛狼疮评估组（BILAG）评估的在 3 个月和 24 个月时达到临床缓解的患者比例。次要终点包括临床缓解时间、BILAG A 和 B 发作率、发作时间、皮质类固醇减少和不良事件（AE）。
在 3 个月（32.5%比 19.2%；治疗差异，13.3（2.3 至 24），p=0.034）和 24 个月（71.2%比 48.3%；治疗差异，22.9（10.4 至 34.4），p<0.001）时，EC-MPS 组达到临床缓解（临床 SLEDAI=0）的患者比例更高。EC-MPS 组在临床缓解时间（HR 1.43；95%CI 1.07 至 1.91；p=0.017）上也具有优势。AZA 组更频繁出现 BILAG A/B 和 B 发作（71.7%比 50%，p=0.001 和 21.67%比 8.3%，p=0.004）。EC-MPS 组在首次 BILAG A/B （HR 1.81；95%CI 1.3 至 2.56；p=0.0004）和 BILAG A 发作（HR 2.84；95%CI 1.37 至 5.89；p=0.003）时间上也具有优势。两组的不良事件相似，但 AZA 组更常出现白细胞减少。
EC-MPS 在治疗 SLE 和预防复发方面优于 AZA。
NCT01112215；结果。
