Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.
BACKGROUND
The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.


METHODS
Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organization 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 complete 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.
Ong
Loke Meng
LM
Department of Medicine, Penang Hospital, Malaysia.
Hooi
Lai Seong
LS
Lim
Teck Onn
TO
Goh
Bak Leong
BL
Ahmad
Ghazali
G
Ghazalli
Rozina
R
Teo
Sue Mei
SM
Wong
Hin Seng
HS
Tan
Si Yen
SY
Shaariah
Wan
W
Tan
Chwee Choon
CC
Morad
Zaki
Z
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D001706:Biopsy; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007275:Injections, Intravenous; D008181:Lupus Nephritis / Q000188:drug therapy* / Q000473:pathology; D008296:Malaysia; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D020551:Pulse Therapy, Drug; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D003520:Cyclophosphamide; D009173:Mycophenolic Acid