A pilot study of 21 patients (17 women; 4 men; mean age 35 [18-59] yea
rs), randomized into two groups, was undertaken to test how many cycle
s of intravenous pulse cyclophosphamide administration were required i
n lupus nephritis to achieve remission. It was planned that patients r
andomized to group A should be treated for 3 months, those in group B
for over 12 months. In the first cycle the cyclophosphamide dosage was
500 mg/m2, in the subsequent cycles, 4 weeks apart, it was raised by
2 50 mg/m2 to a maximum of 1,000 mg/m2, if the WBC count was over 2,00
0/mul. Three women in group B gave up treatment prematurely after 5-8
cycles, because a remission had occurred. In group A only one patient
went into remission after only three cycles. Of the total of 18 patien
ts in both groups whose data could be evaluated, 15 achieved remission
after an average of 7.3 cycles and a cumulative total cyclophosphamid
e dosage of 9.3 g. The disease progressed in two patients, one died. N
o recurrence has so far been observed after a follow-up period of 1-41
months. Three patients had infections and two had developed leukopeni
a as side effects. - Pulse cyclophosphamide has thus been shown to be
an effective treatment in lupus nephritis, but it must be continued fo
r more than 3 months.