Objective: An open label study to determine the feasibility and acute toxicity of a 6 month course of outpatient intermittent bolus high dose oral cyclophosphamide in patients with active systemic lupus erythematosus (SLE).
Methods: Oral cyclophosphamide in a single dose of 0.5 to 1.0 g/m2 was given monthly for 6 consecutive months. Disease activity was monitored by quantitative assessments of urine sediment, 24h urine protein excretion, and the Systemic Lupus Activity Measure (SLAM).
Results: Twelve patients (11 with glomerulonephritis and one with thrombocytopenia) were studied. Improvements in SLAM scores, proteinuria, and urinary cellular casts were observed in the majority of the 9 patients with nephritis who completed the study. Adverse effects included mild nausea in most patients and intercurrent infections in 2 patients (herpes zoster, cellulitis, urinary tract infection). Three patients failed to complete the 6 month course of therapy because of treatment failure in the patient with thrombocytopenia, pregnancy, and severe vomiting, respectively.
Conclusion: High dose pulse oral cyclophosphamide is an acceptable alternative for the aggressive outpatient management of selected patients with lupus nephritis.