Sixteen patients with systemic lupus erythematosus have been observed for from 1 to 4 years while taking prednisone plus azathioprine in a dose of 2.5 mglkglday and compared to 19 patients with systemic lupus erythematosus managed with prednisone alone for a similar period. Patients receiving azathioprine showed a decreased mortality and morbidity, required less daily prednisone than the control group, exhibited no increased tendency to develop infection, had fewer exacerbations of their disease and maintained better renal function. Discontinuation of the azathioprine was associated with severe exacerbations of disease. The toxicity of azathioprine was minimal.Purine analogs and the cytotoxic drugs originally devised for use in neoplastic disease were soon found to have immunosuppressive activity. From this observation, clinical trials in diseases in which immunologic abnormalities are prominent inevitably followed. T h e use of both types of agents became widespread after case reports of their benefit in such diseases were published. T h e present report describes the use of one such drug, azathioprine (Imuran)', in one disease, systemic lupus erythematosus, in a controlled study. T h e study confirms the previous impressions of the usefulness of the drug in this disease, and raises questions as to the precise manner in which the drug is best employed. MATERIALS AND METHODSDuring the 3-year period, June 1966 to June 1969, patients with systemic lupus erythematosus were entered into a controlled, but nonblind study for the evaluation of azathioprine in the management of this illness. The study was performed with FDA approval and informed consent was obtained in all cases. All patients who met the following criteria were included: 1) either a positive LE cell preparation or a positive test for antinuclear antibodies (immunofluorescent technic with guinea pig liver as substrate and serum used in a 1:lO dilution); 2) objective evidence of at least two of the following manifestations of systemic lupus erythematosus: a) arthritis, b) rash, c) serositis, d) myocardi tis, e) thrombocytopenic purpura or a white blood cell count less than 3500/cu m m or hemolytic anemia, f ) renal disease as defined by an endogenous creatinine clearance of less than 75 ml/min or proteinuria greater than 0.5 g/day; and 3) no history of having received immunosuppressive or cytotoxic drugs in the past.All of the patients had positive tests for antinuclear factors. Once the diagnosis of systemic lupus
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