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

• Published in: Nephrology (Carlton, Vic.) Vic.), 2012-05, Vol.17 (4), p.352-357
• Main Authors: YAP, DESMOND YH, YU, XUEQING, CHEN, XIANG-MEI, LU, FUMING, CHEN, NAN, LI, XUE-WANG, TANG, COLIN SO, CHAN, TAK MAO
• Format: Article
• Language: English
• Subjects: Adult; Biomarkers - blood; Biopsy; Chi-Square Distribution; China; Creatinine - blood; Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; lupus; Lupus Nephritis - blood; Lupus Nephritis - complications; Lupus Nephritis - drug therapy; Lupus Nephritis - pathology; Male; membranous; Middle Aged; mycophenolate mofetil; Mycophenolic Acid - adverse effects; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; nephritis; Nephrotic Syndrome - blood; Nephrotic Syndrome - drug therapy; Nephrotic Syndrome - etiology; Nephrotic Syndrome - pathology; Pilot Projects; Prednisolone - therapeutic use; Prospective Studies; Serum Albumin - metabolism; Severity of Illness Index; tacrolimus; Tacrolimus - adverse effects; Tacrolimus - therapeutic use; Time Factors; Treatment Outcome; Young Adult
• ISSN: 1320-5358; 1440-1797
• DOI: 10.1111/j.1440-1797.2012.01574.x

ABSTRACT 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 multi‐centre 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. Optimal treatment of membranous lupus nephritis is still unknown, with a paucity of data on the efficacy of the various forms of immunosuppression and durations of treatment. Albeit a small study, this is a randomized trial comparing mycophenolate and tacrolimus, both new key players in treatment of lupus, with well‐organized methodology. While the small numbers precludes making definite conclusions, the study demonstrates similar outcomes between the two drugs.