#3507 IV CYCLOPHOSPHAMIDE VERSUS MYCOPHENOLATE MOFETIL AS INDUCTION REGIMEN IN PROLIFERATIVE LUPUS NEPHRITIS: A STUDY FROM NORTH-EAST INDIA

Abstract

Abstract Background and Aims SLE is a chronic autoimmune disorder that can affect all organ systems. Clinically evident renal disease known as Lupus Nephritis (LN) occurs in upto 50% patients of SLE and upto 10% of LN patients develop ESRD. LN carries a significant morbidity and mortality and requires an early aggressive management. Our Aim is to study the effect of IV Cyclophosphamide (CYC) vs Mycophenolate Mofetil (MMF) as Induction regimen in proliferative Lupus Nephritis patients of North- East India. Method This is a prospective observational study conducted in the department of Nephrology, Gauhati Medical College, over a period of 1 year. Haematological and biochemical assay including serum creatinine, blood urea, serum albumin, ANA, Anti ds DNA, C3 and C4,24h urinary protein, estimated glomerular filtration rate (eGFR) of all patients were taken into account. Renal biopsy was performed under ultrasonographic guidance. SLEDAI Score and Activity and Chronicity Indexes were calculated for all patients. Statistical analysis was done by SPSS Version 22 for windows. Two tailed p<0.05 was considered to be statistically significant. A total of 64 biopsy proven LN patients of Class III, Class IV and Class V (Plus Class III/ Class IV) were enrolled in the study. We randomly assigned 34 patients with Class III through V lupus nephritis to IV CYC (NIH protocol/monthly) and 30 patients to MMF (2 gm/day) for 24 weeks as Induction Regimen. Both the groups received prednisone, tapered from a maximum starting dosage of 60 mg/day. All the patients were followed up for 6 months. Complete Response (CR) was considered when proteinuria<0.5g/g and Partial Response (PR) when proteinuria< 3g/g or there is reduction in proteinuria by at least 50%. Baseline characteristics and CR and PR were compared between the two groups. Results Of the total 64 patients, 57 patients (89%) were female, and 7 patients were male (11%) with the mean age of 31± 9.45 years. 24% patients had Class III LN and 76% had class IV LN. Complete Response was achieved in 13 patients (43%) in the MMF group and in 15 patients (44%) in CYC group. Partial Response was achieved in 11 patients (36.67%) in the MMF group and in 12 patients (35%) in the CYC group. There was a non-significant statistical difference between the two groups (p value ≥0.05 for both CR and PR). Conclusion The Northeastern population of India consists of various ethnic groups and there are records of variation in response to the Regimens in different geographical areas. In our study from North-east India, IV Cyclophosphamide and Mycophenolate Mofetil showed similar efficacy as Induction Regimen in proliferative Lupus Nephritis. However, there were higher rates of infection in the Cyclophosphamide group.