Supplementary Material for: Mycophenolate as Maintenance Therapy for Lupus Nephritis with Impaired Renal Function

Background: Mycophenolate (MF) is effective as a maintenance therapy after induction therapy in patients with lupus nephritis (LN). However, little is known about its role in patients with impaired renal function. The purpose of this study was to evaluate the efficacy and safety of MF as a maintenance therapy for LN and its association with renal function. Methods: Data were obtained for 56 Spanish patients who were receiving MF as a maintenance therapy for LN. Patients were classified into two groups according to renal function at the initiation of MF treatment: group 1 [estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73 m2] and group 2 (eGFR <60 ml/min/1.73 m2). The primary endpoints of the study were the rates of renal relapse and responses, and their relationship with baseline renal function. Secondary outcomes were the appearance of side effects during treatment. Results: At initiation of MF treatment, the only differences between the groups were for age, hemoglobin levels, anti-DNA antibody titer, proteinuria, and renal function. In group 1 (n = 38), the eGFR was 98 ± 34 ml/min/1.73 m2 and in group 2 (n = 18) the eGFR was 43 ± 14 ml/min/1.73 m2. Only 3 cases had an eGFR <30 ml/min/1.73 m2. No significant differences were observed in the rate of relapse at 6 months (group 1: 20%; group 2: 23%) or at 12 months (group 1: 25%; group 2: 17%). Response rates were also similar in both groups. Side effects were unremarkable. Conclusions: MF is effective and safe as a maintenance therapy for LN both in patients with normal renal function and in those with renal impairment.

背景：吗替麦考酚酯（Mycophenolate, MF）可作为狼疮肾炎（lupus nephritis, LN）患者诱导治疗后的维持治疗方案，疗效肯定。但目前针对其在肾功能受损患者中的应用价值，相关研究尚少。本研究旨在评估MF用于LN维持治疗的疗效与安全性，及其与患者肾功能的关联。
方法：本研究纳入56例接受MF作为LN维持治疗的西班牙患者，依据MF治疗启动时的肾功能水平将其分为两组：组1[估算肾小球滤过率（estimated glomerular filtration rate, eGFR）≥60 ml/min/1.73 m²]与组2（eGFR <60 ml/min/1.73 m²）。本研究的主要终点为肾脏复发率、缓解率及其与基线肾功能的相关性；次要结局为治疗期间不良反应的发生情况。
结果：MF治疗启动时，两组患者仅在年龄、血红蛋白水平、抗DNA抗体（anti-DNA antibody）滴度、蛋白尿及肾功能方面存在差异。组1（n=38）的eGFR为98±34 ml/min/1.73 m²，组2（n=18）的eGFR为43±14 ml/min/1.73 m²，仅3例患者的eGFR<30 ml/min/1.73 m²。6个月随访时，两组复发率分别为20%与23%；12个月随访时，两组复发率分别为25%与17%，均未观察到显著组间差异。两组的缓解率亦无显著差异。不良反应均无显著临床意义。
结论：MF作为LN的维持治疗方案，在肾功能正常及肾功能受损的LN患者中均表现出良好的疗效与安全性。