Effectiveness and safety of cyclophosphamide or tacrolimus therapy for idiopathic membranous nephropathy.

Abstract

Guidelines recommend classical combined therapy of steroid and cyclophosphamide (CYC) for patients with idiopathic membranous nephropathy (IMN), while it is associated with severe adverse effects. We conducted an observational and retrospective study to evaluate the effectiveness and safety of steroids plus tacrolimus (TAC) versus steroids plus CYC for IMN. A total of 203 kidney-biopsy-proven IMN patients was enrolled in this study. One group (n = 142) received steroid combined with intravenous CYC (750 mg/m2 body surface) and the other group (n = 61) received steroid combined with oral TAC (target blood concentration of 4-8 ng/mL). The primary outcomes were achievement of remission. The secondary end-points included incidence of adverse events, relapse rates, 24 h urinary protein (UP), serum albumin, serum creatinine and estimated glomerular filtration rate. Over the 18-month observation period, the study suggested that the remission rates at the first 3 months were significantly higher in TAC group than in CYC group (72.1% vs 54.9%, P < 0.05). Although the cumulative incidence of serious and non-serious adverse events was not different significantly between the two groups, the incidence after first 3 months was lower in TAC group. Levels of 24-h UP and serum albumin improved in the TAC group more than in the CYC group (P < 0.05) over the observed period. Because of its short-term effectiveness and long-term safety profile, steroid plus TAC might be a better option for IMN.