Table 2.
Summary of Efficacy Endpoints at week 12*
Efficacy Outcome | Results of subjects who completed trial (n=8) |
Results of intention to treat analysis (n=12)* |
---|---|---|
Response rate based on achieving at least a PGA of “good” | 25%, 95% CI (3%, 65%) | 16.7%, 95% CI (2%, 48%) |
PGA at week 12 (median, IQR) | Unchanged-Slight improvement (Unchanged, Fair-Good) |
Unchanged (Worse-Unchanged, Slight Improvement) |
PASI 75 at week 12 | 25%, 95% CI (3%, 65%) | 16.7%, 95% CI (2%, 48%) |
Change in PASI (baseline-week 12) (median, IQR) | 5.4 (0.65, 7.6) p= 0.04 | 0.65 (−1.25, 6.5) p=0.26 |
Change in Skindex**(median, IQR) | 0.35 (IQR −5.5, 5.0) p= 0.9 | 0.0 (−2.55, 4.95) p=0.63 |
data taken from latest visit and carried forward for subjects who withdrew.
positive values indicate an increase in Skindex scores, suggesting a decrease in QOL