To evaluate the effectiveness of cyclophosphamide in the treatment of lupus nephritis, we designed a prospective study of patients with diffuse proliferative lupus nephritis. Twenty-six patients received prednisone (average dose, 40 mg per day) and 24 combined prednisone (average dose, 29 mg per day) and cyclophosphamide (average dose, 107 mg per day) for six months. Thereafter, all patients received maintenance doses of prednisone. Most of the patients improved (84 per cent) after six months of initial treatment with either program. Early progression of disease, ending mainly in end-stage renal disease, was equally frequent in the two treatment groups in patients with already advanced disease. In a four-year follow-up study there was a higher incidence (P approximately 0.04) and average rate (P approximately 0.02) of clinical recurrence of nephritis in the group initially given only steroid than in the group initially given both drugs. However, the proportion of patients alive after four years with stable or improved renal function was similar in the two treatment groups.
In extending an initial 6-month study to 3 years, treatment of patients with lupus nephritis by a combination of prednisone and azathioprine did not control the systemic or renal manifestations any better than did treatment with prednisone alone. There were no differences in major renal disease flares between the two treatment groups. The incidence and duration of systemic, nonrenal flares were greater in the combined treatment group but did not increase after treatment with azathioprine was discontinued.In a prospective, controlled 6-month study of patients with lupus nephritis, we found no added therapeutic benefit from combined high-dose prednisone and azathioprine as compared with high-dose pred- (1). Patients were selected on the basis of clinical, immunologic, and renal histologic criteria, and by random allocation received either prednisone (average dose, 40 mg/day for 6 months) or prednisone (same dosage) and azathioprine (2 to 5 mg/kg/day). There was no greater improvement in symptomatic, seroimmunologic, or renal functional or morphologic parameters in one group as compared with the other. In further observations of all patients for an average follow-up of 3 years, there was no difference in the frequency of renal relapse between the two treatment groups. The incidence and duration of systemic, nonrenal flares were greater in the group given combined prednisone-azathioprine, whether azathioprine was being given or whether its use had been discontinued, and the dosage of prednisone required rnatology and Internal Medicine, Mayo Clinic and Mayo Foundation; Associate Professor of Medicine; FREDERlC C MCDUFFIE.
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