Alternative Modes of Cyclophosphamide and Azathioprine Therapy in Lupus Nephritis

Abstract

Patients [41] with systemic lupus erythematosus and glomerulonephritis were studied in a randomized drug trial. Patients [13] received prednisone only (group 1), 16 received oral cyclophosphamide and oral azathioprine (1 mg/kg body wt per day of each initially) (group 2) and 12 were given boluses of i.v. cyclophosphamide (0.5 to 1.0 g/m2 body surface area every 3 mo.) (group 3). The mean observation period was 42 mo. (1-6.5 yr). Renal function deteriorated in 4 of 12 patients in group 1 and 3 of 27 patients in groups 2 and 3 (P = 0.114). By life-table analysis, 86% of the entire group survived 5 yr after entry to the study. Marked hypertension, fluctuating changes in serum creatinine, erratic changes in levels of antibody to DNA, reduced C3 levels, increasing proteinuria or sustained hematuria and flares of extrarenal disease activity occurred more commonly in group 1. Infectious complications were not commoner in groups 2 and 3. Evidently, any marginal benefits produced by the programs tested cannot be shown in this class of patients without markedly increasing the sample size.