Two-Year Follow-up Study of Membranous Nephropathy Treated With Tacrolimus and Corticosteroids Versus Cyclical Corticosteroids and Cyclophosphamide.

Introduction: Both cCTX/GCs and CNIs are recommended as first-line agents in the management of PMN. The present study is an extended report of patients randomized to receive TAC/GCs or cCTX/GCs at 2 years post randomization.

Methods: Seventy patients enrolled in the clinical trial Tacrolimus Combined With Corticosteroids Versus Modified Ponticelli Regimen in Treatment of Idiopathic Membranous Nephropathy: Randomized Control Trial were followed quarterly between 12 and 24 months. At the end of 24 months, 3 patients were lost to follow-up.

Results: At 18 months, 66% and 89% ( P  = 0.04) were in remission in TAC/GCs and cCTX/GCs groups, respectively. At 18 and 24 months, 60% and 86% ( P  = 0.03) of cases were in remission in the TAC/GCs and cCTX/GCs groups, respectively. At 18 months, 57% and 83% ( P  = 0.03) of the patients in TAC/GCs and cCTX/GCs groups were in remission without need of any additional immunosuppression (persistent remission) and, at 24 months, 43% and 80% ( P  = 0.002) were in persistent remission in TAC/GCs and cCTX/GCs groups, respectively. Relapse rate after any remission was 40% and 6.7% in TAC/GCs and cCTX/GCs groups, respectively ( P  = 0.007). There was an association of aPLA2R titers with remission or resistance ( P  = 0.006) in relapsing PMN. The significant decrease in eGFR after 12 months of TAC/GCs therapy normalized at 18 and 24 months.

Discussion: At 2 years after randomization, relapse rates are higher for TAC/GCs compared with cCTX/GCs in PMN patients. Thus, cCTX/GCs are better than TAC/GCs in the longer term in PMN patients.