Comparison Of The Efficacy Between The Mycophenolate Mofetil Plus Cyclophosphamide And Cyclophosphamide Alone In The Induction Treatment Of Lupus Nephritis

ObjectiveTo investigate the efficacy and safety of corticosteroid along with mycophenolate mofetil(MMF)and cyclophosphamide(CYC)(multi-target group)compared with traditional corticosteroid plus cyclophosphamide(CYC alone)in the induction treatment of lupus nephritis(LN).MethodsFifty SLE patients with biopsy proven class ?,?,?,?+? and ?+? were recruited into multi-target group(n=25)and IVCY group(n=25).Both groups were initially treated with oral prednisone(1mg/kg)then tapered.In multi-target group,the dose of MMF was 1g/d and the blood level of it(MPA-AuC0-12h)was in the range of 20-30 mg.h/L,and CYC was given in 0.6g intravenously every 2 weeks for 6 times(maximum total dose 3.6g).In IVCY group,the dose was 0.75g/m2 intravenously monthly(maximum single dose 1.2g)for 6 times(maximum total dose 9.0g).The length of induction was 6-9 months.The primary efficacy endpoint was complete remission rate(CR,defined as Urinary protein <0.4g/24 h,serum albumin ?35 g/L,normal serum creatinine and no extra-renal flare).The efficacy and safety between the two groups were compared.ResultsThere is no differences in terms of baseline characteristics,clinical parameters and pathologic profile between the two groups.The CR rate in multi-target group,compared with in IVCY group,was much higher at 3 months and 6 months(44.0% vs 16.0% p<0.05,72.0% vs 44.0% p<0.05,respectively).For the LN class ?+?,the CR rate in multi-target group was significantly higher than that in IVCY group,while the other classes was not calculated owing to small size of samples.The time length to CR of the multi-target group was far shorter than that of IVCY group(17.55±9.53 weeks vs.24.13±9.92 weeks,p<0.05).The urine protein fell more dramatically in multi-target group([86.8±20.9]% vs.[66.7±30.5]%,p<0.01).The overall incidence of adverse events in both groups was similar(28.0% vs.52.0%,p>0.05),the major adverse events were gastrointestinal discomfort(8%)and infection(12%)in the multi-target group,while in the IVCY group were gastrointestinal discomfort(16%),infection(16%),alopecia(8%)and menstrual disorders(8%).No death occurred.Conclusion1.Both Multi-target therapy composed of corticosteroid plus mycophenolate and cyclophosphamide and traditional IVCY are effective and safe in inducing remission in type ?,?,?,?+? and ?+? lupus nephritis.2.Multi-target therapy composed of corticosteroid plus mycophenolate and cyclophosphamide,when compared with traditional IVCY,has higher complete remission rate in inducing remission of lupus nephritis,particularly for class ?+? lupus nephritis.Moreover,the time from treatment initiation to remission in Multi-target therapy is much shorter,which is valuable for the prognosis of lupus nephritis.3.The overall safety of Multi-target therapy is good,and the gonadoinhibitory is slight.However,multi-center trials with long period of follow-up are needed to confirm the clinical efficacy and long-term prognosis of multi-target therapy.