Pilot 24 month study to compare mycophenolate mofetil and tacrolimus in the treatment of membranous lupus nephritis with nephrotic syndrome

Aim: This pilot study compared mycophenolate mofetil (MMF) and tacrolimus (Tac) in the treatment of severe membranous lupus nephritis (MLN). Method: This was a 24 month prospective, randomized, open-label multicentre exploratory study on Chinese patients with biopsy-proven pure Class V MLN with nephrotic syndrome. Patients were randomized to treatment with either MMF or Tac, both in combination with prednisolone and the efficacy and tolerability outcomes were examined. Results: Sixteen patients were included, seven in the MMF and nine in the Tac treatment arm. At 24 months the complete response, partial response and overall response rates were 57.1% vs. 11.1% (P = 0.049), 14.3% vs. 44.4% (P = 0.197) and 71.4% vs. 55.6% (P = 0.515) in the MMF and Tac groups, respectively. The two groups had similar reduction of proteinuria and longitudinal profiles of serum albumin and creatinine levels. Serum creatinine remained stable in both groups, except in two patients who had a transient increase associated with high Tac blood levels. Adverse events in the MMF group included herpes zoster in one patient and reversible leucopenia in another, while in the Tac group four patients had severe infections and one developed new onset diabetes. No relapse occurred during the study period. Conclusion: Both MMF and Tac when combined with corticosteroids are effective treatment options for severe MLN. Membranous lupus nephritis (MLN) in the absence of significant endocapillary proliferation (Class V according to ISN/RPS 2003 Classification) typically presents with variable degrees of proteinuria with or without renal impairment and is associated with a relatively slower rate of renal function deterioration compared with focal (Class III) or diffuse proliferative lupus nephritis (Class IV) with 10 year renal survival rates of 72‐90%. 1‐4