STATISTICAL METHODS
Mean BSA in all patients randomized in the maintenance phase (full analysis set [FAS]) was estimated for each visit. The change in mean BSA between visits 1 and 2 (corresponding respectively to the beginning and end of the four-week open-label phase) was assessed using a paired t-test (Table 1).
For each patient, the integrated AUC was calculated for BSA using the trapezoidal rule and subsequently normalized by number of days of exposure. The means and frequency distributions of AUC values were compared between the proactive and reactive arms, with statistical significance assessed using the Wilcoxson signed-rank test. To better understand the impact of patients’ study participation and disease status on observed results, this FAS analysis was repeated, disaggregated by:
For each patient, the integrated AUC was calculated for BSA using the trapezoidal rule and subsequently normalized by number of days of exposure. The means and frequency distributions of AUC values were compared between the proactive and reactive arms, with statistical significance assessed using the Wilcoxson signed-rank test. To better understand the impact of patients’ study participation and disease status on observed results, this FAS analysis was repeated, disaggregated by:
- completion status (completers, dropouts);
- disease status (remission, relapse).
RESULTS
A total of 521 patients comprised the FAS population in which the mean BSA was measured, the baseline characteristics for the randomized population are reported in the primary publication.1 The AUC was calculated for 512 patients of the FAS population, in which one or more BSA estimate was measured. Roughly half of the patients included in the AUC analysis completed the study protocol (n=246), and the remainder dropped out before the end of the 52-week maintenance period (n=266).
Figure 1 shows mean BSA by visit number for both the proactive and reactive arm. The marked reduction in BSA from visit 1 to 2 of 4.8 points (Table 1), during the four-week open-label phase reflects the response to once daily Cal/BD foam treatment and was statistically significant (P<0.0001). Improvements in mean BSA were maintained throughout the study period of 52 weeks, with values remaining consistently lower for the proactive arm versus the reactive arm.
Figure 2 shows that AUC values were lower for the proactive arm versus the reactive arm regardless of completion status. This difference (Table 2) was statistically significant in the
Figure 1 shows mean BSA by visit number for both the proactive and reactive arm. The marked reduction in BSA from visit 1 to 2 of 4.8 points (Table 1), during the four-week open-label phase reflects the response to once daily Cal/BD foam treatment and was statistically significant (P<0.0001). Improvements in mean BSA were maintained throughout the study period of 52 weeks, with values remaining consistently lower for the proactive arm versus the reactive arm.
Figure 2 shows that AUC values were lower for the proactive arm versus the reactive arm regardless of completion status. This difference (Table 2) was statistically significant in the
