Table 2.

Complete remission rates and relapse after complete remission to within 24 weeks after study drug initiation, by study group (modified ITT and PPS)

ParameterTacrolimus and Low-Dose SteroidHigh-Dose SteroidP value
Modified ITT set
 Patients who showed complete remission within 8 wk after study drug initiation, n (%)53/67 (79.1)53/69 (76.8)
 Patients who showed relapse after complete remission to within 24 wk after study drug initiation, n (%)3/53 (5.7)12/53 (22.6)0.01a
 Median time from complete remission to relapse within 24 wk after study drug initiation (d)bb0.02c
 Time from complete remission to 25% relapse within 24 wk after study drug initiation (d)d161
PPS
 Patients who showed complete remission within 8 wk after study drug initiation, n (%)33/39 (84.6)38/44 (86.4)
 Patients who showed relapse after complete remission to within 24 wk after study drug initiation, n (%)1/31 (3.2)8/36 (22.2)0.02a
 Median time from complete remission to relapse within 24 wk after study drug initiation (d)bb0.03c
 Time from complete remission to 25% relapse within 24 wk after study drug initiation (d)d161
  • a P value by Pearson’s chi-squared test.

  • b As relapse-free survival rate was not decreased to <50% in both groups, median time from complete remission to relapse could not be estimated.

  • c P value by log-rank test comparing the full relapse time distributions from complete remission to within 24 weeks.

  • d As 25% relapse was not reached in the tacrolimus and low-dose steroid group, time from complete remission to 25% relapse could not be estimated.