Table 2.

Parameter estimates of dose-PK models

Analysis	Parameter	Estimate	RSE (%)	p-value	90% CI
Phase II SLR (QD only)	Exponent on API dose	0.805	11.0	< 0.0001	0.658–0.951
Phase III SLR (BID only)	Exponent on API dose	0.801	6.4	< 0.0001	0.717–0.886
Phase III final model	Exponent on API dose	0.462	11.6	< 0.0001	0.356–0.567
	Exponent on region = Europe	0.782	12.3	< 0.0001	0.594–0.970
	Exponent on baseline IGA 3	0.322	31.5	0.0008	0.123–0.522
	Exponent on transformed %BSA	0.602	14.0	< 0.0001	0.436–0.767

RSE = standard error/estimate × 100 (%)

Transformed %BSA was derived as log (%BSA/median) in which the observed median %BSA was 8.1%

API active pharmaceutical ingredient, BID twice daily, BSA body surface area, CI confidence interval, IGA Investigator’s Global Assessment, QD once daily, PK pharmacokinetic, RSE relative standard error, SLR simple linear regression between log-transformed concentrations and API dose