Mycophenolate as Maintenance Therapy for Lupus Nephritis with Impaired Renal Function

Abstract

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.

Mycophenolate in Refractory and Relapsing Lupus Nephritis

“…Our results add data to those obtained in a Spanish national survey about the role of MF as induction and maintenance treatment in LN [5,6]. The current study has the following characteristics.…”

“…Our study is limited by its retrospective and multicenter nature, as were our previous studies on induction and maintenance treatment in MF [5,6]. According to our results, MF could be the preferred choice of treatment in relapsing or refractory LN.…”

“…We previously reported on the role of MF as induction therapy [5] and maintenance therapy [6] in LN. The inclusion criteria in the current investigation were as follows: (i) diagnosis of systemic lupus erythematous according to the criteria of the American College of Rheumatology, (ii) biopsy-proven LN, (iii) use of MF in refractory or relapsing LN, and (iv) treatment for a minimum of 3 months.…”

“…Responses (partial or complete) and relapses were defined according to the criteria of our previous studies [5,6]. Complete response was defined as a return to normal or previous eGFR and proteinuria ≤0.5 g/24 h. Partial response was defined as a decrease in proteinuria to <3.5 g/24 h and a ≥50% decrease in proteinuria in patients with baseline proteinuria ≥3.5 g/24 h, or as a 50% decrease in proteinuria in patients with baseline proteinuria <3.5 g/24 h. In both situations, eGFR had to have stabilized (±25%) or improved.…”

“…Furthermore, this favorable profile has been observed in patients with renal impairment [5,6,7]. Although no randomized clinical trials have been performed in patients with CYC-refractory and relapsing LN, several reports and small cases series have shown that MF is highly effective and well tolerated and that it could be a good alternative in patients with LN [8,9,10].…”