Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis

Abstract

SUMMARY: Background: The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induc- tion therapy of proliferative lupus nephritis. Methods: Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organiza- tion class III or IV were randomly assigned to either mycophenolate mofetil (MMF) 2 g/day for 6 months or intravenous cyclophosphamide (IVC) 0.75-1 g/m 2 monthly for 6 months in addition to corticosteroids. Results: Remission occurred in 13 out of 25 patients (52%) in the IVC group and 11 out of 19 patients (58%) in the MMF group ( P = 0.70). There were 12% in the IVC group and 26% in the MMF group that achieved com- plete remission ( P = 0.22). Improvements in haemoglobin, the erythrocyte sedimentation rate, serum albumin, serum complement, proteinuria, urinary activity, renal function and the Systemic Lupus Erythematosus Disease Activity Index score were similar in both groups. Twenty-four follow-up renal biopsies at the end of therapy showed a significant reduction in the activity score in both groups. The chronicity index increased in both groups but was only significant in the IVC group. Adverse events were similar. Major infections occurred in three patients in each group. There was no difference in gastrointestinal side-effects. Conclusions: MMF in combination with corticosteroids is an effective induction therapy for moderately severe proliferative lupus nephritis. Systemic lupus erythematosus (SLE) is a multisystem disease characterized by abnormalities of T and B cells and produc- tion of autoantibodies. Renal involvement occurs in approximately 40-75% of patients and is associated with increased morbidity and mortality. 1 Severe proliferative lupus nephritis is associated with a poor renal prognosis and requires aggressive therapy. Addition of cytotoxic agents to corticosteroids has been shown to improve the outcome of severe lupus nephritis in randomized controlled studies and meta-analyses. 2-4 In the National Institute of Health studies,