Table 2.

Efficacy outcomes.

	Week 0–12: placebo-controlled period			Week 12–24: open-label period
	Roflumilast n = 23	Placebo n = 23	P-value	Roflumilast until week 12 n = 23	Placebo until week 12 n = 23
PASI50, n (%)	16 (70)	1 (4)	<0.0001	15 (65)	13 (57)
PASI75, n (%)	8 (35)	0 (0.0)	0.014	10 (44)	9 (39)
PASI90, n (%)	3 (13)	0 (0.0)	0.25	5 (22)	3 (13)
PASI100, n (%)	2 (9)	0 (0.0)	0.49	2 (9)	0 (0)
$\Delta$PASI, mean (SD)	−7.6 (3.6)	−0.9 (7.2)	0.014	−8.0 (4.3)	−5.7 (5.4)
$\Delta$PASI %, median (IQR)	−61.7 (−77.8, −48.4)	−3.7 (−18.5, 23.8)	0.014	−69.2 (−86.0, −38.1)	−59.5 (−76.6, −16.0)
$\Delta$sPGA, median (IQR)	−1.0 (−1.5, −1.0)	0.0 (0.0, 0.0)	0.014	−1.0 (−2.0, 0.0)	−1.0 (−1.0, 0.0)
$\Delta$sPGA ≤ -1, n (%)	17 (74)	4 (17)	0.00011	14 (61)	12 (52)
$\Delta$BSA, mean (SD)	−11.8 (13.5)	−2.8 (14.7)	0.083	−12.5 (8.7)	−13.2 (14.8)
$\Delta$BSA %, median (IQR)	−81.8 (−93.8, −30.8)	6.2 (−15.6, 37.7)	0.024	−66.4 (−96.7, −32.4)	−77.4 (−93.4, −26.7)
$\Delta$BSA ∗ sPGA, median (IQR)	−9.0 (−19.8, −2.0)	1.0 (−8.2, 13.3)	0.018	−11.5 (−20.0, −3.2)	−11.8 (−18.2, −1.5)
$\Delta$DLQI, mean (SD)	−6.8 (5.0)	−3.2 (6.1)	0.031	−7.4 (4.6)	−3.7 (6.0)

Data are shown for all randomized patients. Categorical variables are presented in frequencies and percentages. Numerical data are shown in medians and IQR (non-normally distributed data) or mean and SD (normally distributed data). Δ refers to change from start of current therapy. Missing data are handled with NRI (non-responder imputation) for binary outcomes or LOCF (last observation carried forward) for non-binary outcomes. Bold values denote statistically significant results.

BSA, body surface area; DLQI, dermatology life quality index; IQR, interquartile range; PASI, psoriasis area and severity index; PASI50, at least 50% reduction in baseline PASI; PASI75, at least 75% reduction in baseline PASI; PASI90, at least 90% reduction in baseline PASI; PASI100, 100% reduction in baseline PASI; SD, standard deviation; sPGA, static physician global assessment.