OP0283 MYCOPHENOLATE MOFETIL VS CYCLOPHOSPHAMIDE FOR TREATMENT OF LUPUS NEPHRITIS: A SINGLE-CENTER COHORT REAL-WORLD ANALYSIS

Abstract

BackgroundMycophenolate mofetil (MMF) or low-dose intravenous cyclophosphamide (CYC) are recommended as initial (induction) treatment in many recommendations for the management of lupus nephritis (LN), and randomized controlled trials have shown their similar efficacy. However, there is little to no real-world data.ObjectivesWe conducted the real-world analysis to compare the efficacy and safety of MMF and CYC for the induction treatment of LN.MethodsOur patients came from PKUFH SLE cohort, a single-center longitudinal observational cohort set up in 2007, and only patients received initial remission induction therapy for initial or recurrence LN were analyzed. The primary outcome measure was complete renal remission (CR) as defined by (proteinuria <500 mg/24 hours and serum creatinine within 10% from baseline in 12 month. All statistical analyses were performed with SPSS 26.0 and two sides p < 0.05 was considered statistically significant.ResultsThe 237 LN patients with a median age of 35.0 years had a mean duration of disease of 5.2 years. Of these, 97 patients received CYC, 98 patients received oral MMF, and 42 patients received other immunosuppressive agents or combination therapy. The CR rate in 6-month in MMF was significantly higher than CYC group (CR 57.6% vs 45.2%, p=0.005), and that also applied to 12 month (74.7% vs 56.3%, p=0.001). MMF group patients had lower serum creatinine (76.8±14.5 vs. 93.3±62.9, p=0.012), lower dose glucocorticoid exposure (9.7±3.3vs.11.2±5.6, p<0.05), and lower 24-hour protein level (0.4±0.7 vs. 0.7±1.0, p=0.017) than CYC group. However, MMF did not showed superior to CYC in the LN induced remission (6 month:87.5% vs 73.7%, p=0.064, 12 month:87.7% vs 90.6%, p=0.632) after propensity score matching, just as the Kaplan-Meier analysis showed (Figure 1). Chinese patients usually adopted lower dose MMF (78.8% 1.5g/d,) compared Caucasian populations, and which was also effective.Figure 1.Kaplan-Meier analysis of complete(left) or at least partial remission rate (right)in 12 month after propensity score analysis.97(47.5%) patients had at least one adverse event, 34% patients had experienced one or more infection. CYC group patients had higher incidence of digestive adverse reactions compared with MMF group (16.3% vs. 2.1%, p<0.001), and no evidence for a statistically significant difference in other aspects. However, patients with CYC induce-therapy are more likely to develop menstrual disturbance (11.2% vs 4.1%) and pneumonia (11.2% vs 3.1%), even failed to reach statistical significance.No significant difference attributable to ACEIs or ARBs was found in remission rates, SLEDAI, C3 lever and prednisone dose. However, ACEIs/ARBs was benefit to decrease the urine protein (0.2±0.3 vs 0.6±1.0, p=0.031) and may increase the plasma albumin (41.8±3.8 vs 40.6±3.4, p=0.130), thus protect renal function (SCr 74.7±13.4 vs 100.4±82.0, p=0.027). There was no significant difference in remission rate and other parameters, regardless of Hydroxychloroquine (HCQ) or not.ConclusionThis was the first real-word study to compare the effectiveness and safety of MMF in LN compared with low dose CYC. We found that MMF had similar induced remission rate, with lower gastrointestinal adverse reactions and may less influence on menstruation and less pneumonia, even at relatively low doses. ACEIs/ARBs was benefit to decrease the urine protein and protect renal function.