Comparison of the efficacy between the mycophenolate mofetil plus cyclophosphamide and cyclophosphamide alone in the induction treatment of lupus nephritis: a prospective clinical trial

LIU Qi; LUO Xiang-ya; CHEN Rui-lin; LIN Ze-ying; HUANG Wen-hui

doi:10.3969/j.issn.1001-9448.2017.14.031

Abstract：Objective To prospectively 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).Methods Fifty SLE patients with biopsy proven class Ⅲ, Ⅳ, Ⅴ, Ⅲ+Ⅴ and Ⅳ+Ⅴ were randomly recruited into multi-target group (n=25) and IVCY group (n=25).Both groups were initially treated with oral prednisone (1 mg/kg) then tapered.In multi-target group, the dose of MMF was 1 g/d and its blood level (MPA-AuC0-12h) was in the range of 20-30 mg·h/L, and CYC was intravenously given in 0.6 g every 2 weeks for 6 times.In IVCY group, the dose was 1.0 g intravenously monthly for 6 times.The length of induction was 6 months.The primary efficacy endpoint was complete remission rate (CR, defined as Urinary protein<0.4 g/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.Results There is no significant differences in baseline characteristics, clinical parameters or pathologic profile between the two groups.The CR rate in multi-target group, compared with that in ⅣCY group, was significantly 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 Ⅳ+Ⅴ, the CR rate in multi-target group was significantly higher than that in IVCY group, while the among other classes it was not calculated owing to small size of samples.The time length to CR in the multi-target group was significantly shorter than that in 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 gastrointestinal discomfort (16%), infection (16%), alopecia (8%) and menstrual disorders (8%) in IVCY group.No death was reported.Conclusion Multi-target therapy composed of corticosteroid plus mycophenolate and cyclophosphamide, when compared with traditional IVCY, is more effective and safe in inducing remission in lupus nephritis, particularly for class Ⅴ+Ⅳ.Moreover, Multi-target therapy provides a significantly higher CR rate in the early induction period.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.