Controlled Studies of Oral Immunosuppressive Drugs in Lupus Nephritis

Abstract

From 1969-1975, 53 patients with lupus nephritis took part in randomized trials comparing prednisone, oral azathioprine plus low-dose prednisone and oral cyclophosphamide plus low-dose prednisone. After a mean follow-up of 85 mo., cyclophosphamide appears marginally superior to prednisone for maintaining renal function (P = 0.03) and preventing end-stage renal failure (P = 0.07). Chronic change shown by renal biopsy assessed by a chronicity index was useful in predicting renal function outcomes and response to immunosuppressive therapy. Three of 21 patients with a low chronicity index and 9 of 10 patients with a high chronicity index doubled their serum creatinine (P < 0.00003). The probability of renal functional deterioration was not different among the treatments studied. However, in 14 patients with an intermediate chronicity index, 1 of 11 patients treated with azathioprine or cyclophosphamide doubled the serum creatinine level whereas all 3 patients treated with prednisone progressed to end-stage renal failure (P = 0.005). Single-drug oral immunosuppressive treatment combined with prednisone is apparently most beneficial in lupus patients with intermediate chronic change shown by renal biopsy.