Figure 1125

A, The probability of end-stage renal disease in patients with proliferative lupus nephritis treated with different drug regimens. This update of the prospective trial by the National Institutes of Health (NIH) on the treatment of these patients clearly demonstrates that prednisone monotherapy, in a significantly greater proportion of patients, leads to the development of end-stage renal disease compared with patients on regimens containing cytotoxic drugs. The results between azathio-prine and drug regimens containing cyclophosphamide are not significantly different. Note that in up to 7 years the results do not differ between the different treatment groups. From these studies it is clear that although the therapeutic efficacy is equal for the three treatment regimens containing cyclophosphamide, less side effects occurred in patients treated with intravenous pulses of cyclophosphamide.

B, Renal survival in patients with World Health Organization (WHO) class IV lupus nephritis treated with either cyclophosphamide (CPM) or azathioprine (AZ). The NIH trial [56,59] did not reveal a significant difference between the therapeutic efficacy of cyclophosphamide and azathioprine (A). However, the side effects of both drugs are not identical. Cyclophosphamide has a greater bone marrow toxicity, leads to amenorrhea in many patients, is teratogenic, and displays an unique urothelial toxicity (hemorrhagic cystitis and bladder carcinoma). Therefore, prospective studies comparing cyclophosphamide with azathioprine are warranted but not available. The results of the NIH trial are compared with those reported for azathioprine [57,60-62]. This analysis, carried out by Cameron [57], does not reveal a significant difference between cyclophosphamide and azathioprine. A recent meta-analysis [63] again showed that monotherapy with prednisone was inferior to treatment with cytotoxic drugs in combination with steroids. However, as in the NIH trial and the analysis by Cameron, no differences were found between cyclophosphamide and azathio-prine in preserving renal function. AZ—azathioprine; AZCY— combined therapy with azathioprine and cyclophosphamide; IVCY—intravenous pulses of cyclophosphamide; POCY—oral cyclophosphamide. (Panel A from Steinberg and Steinberg [59]; with permission. Panel B from Cameron [57]; with permission.)

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