A Phase IIIb, Multicentre, Interventional, Randomised, Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Guselkumab for the Treatment of Nonpustular Palmoplantar Psoriasis (G-PLUS)
Table 1
Demographic and baseline disease characteristics (full analysis set).
Variable
Placebo
Guselkumab 100 mg q8w
Age, years
n = 39
n = 78
Mean (SD)
47.8 (13.14)
51.6 (13.27)
Median (IQR)
52 (37.0; 57.0)
55 (43.0; 61.0)
Male
n = 39
n = 78
n (%)
24 (61.5)
36 (46.2)
Weight, kg
n = 39
n = 77
Mean (SD)
894 (20.03)
84.8 (19.76)
Median (IQR)
85.0 (77.0; 97.0)
83.0 (72.1; 95.0)
BMI, kg/m2
n = 39
n = 77
Mean (SD)
29.7 (6.66)
29.0 (6.29)
Median (IQR)
28.5 (26.2; 31.7)
28.3 (24.5; 32.4)
Normal, <25, n (%)
6 (15.4)
23 (29.9)
Overweight, ≥25 to <30, n (%)
20 (51.3)
22 (28.6)
Obese, ≥30, n (%)
13 (33.3)
32 (41.6)
Plaque psoriasis disease duration, years
n = 39
n = 78
Mean (SD)
11.1 (10.31)
13.3 (12.93)
Median (IQR)
8.0 (3.8; 15.0)
8.5 (3.0; 19.0)
Palm involvement disease duration, years
n = 37
n = 74
Mean (SD)
8.1 (9.15)
9.9 (12.07)
Median (IQR)
4.0 (2.0; 10.0)
5.0 (2.0; 11.0)
Sole involvement disease duration, years
n = 31
n = 67
Mean (SD)
7.9 (8.70)
10.6 (12.69)
Median (IQR)
4.0 (2.0; 14.0)
5.0 (2.0; 13.0)
ppPASI score (0–48)
n = 39
n = 78
Mean (SD)
12.7 (7.05)
14.8 (9.70)
Median (IQR)
12.0 (6.6; 19.5)
11.9 (7.2; 20.4)
ppIGA score
n = 39
n = 78
Moderate (3), n (%)
25 (64.1)
53 (67.9)
Severe (4), n (%)
14 (35.9)
25 (32.1)
BSA score (%)
n = 39
n = 78
Mean (SD)
6.9 (3.74)
7.0 (4.25)
Median (IQR)
6.0 (4.0; 8.0)
6.0 (4.0; 9.0)
PASI score (0–72)
n = 39
n = 78
Mean (SD)
6.0 (2.27)
6.2 (1.93)
Median (IQR)
5.7 (3.7; 8.0)
6.0 (4.8; 7.9)
ppQLI score
n = 39
n = 78
Palms
Mean (SD)
41.0 (14.21)
43.4 (15.74)
Median (IQR)
41.0 (29.0; 52.0)
42.5 (31.0; 55.0)
Soles
Mean (SD)
33.0 (13.78)
33.9 (14.54)
Median (IQR)
32.0 (19.0; 44.0)
32.5 (21.0; 49.0)
Total score
Mean (SD)
43.4 (13.02)
45.9 (14.34)
Median (IQR)
42.0 (32.0; 54.0)
46.5 (33.0; 57.0)
DLQI score (0–30)
n = 39
n = 77
Mean (SD)
14.4 (5.87)
15.0 (7.49)
Median (IQR)
14.0 (10.0; 19.0)
15.0 (9.0; 21.0)
WPAI: PSO questionnaire
n = 29
n = 50
Absenteeism, mean (SD)
13.9 (31.65)
8.6 (24.10)
Total work productivity impairment, mean (SD)
38.5 (34.98)
41.3 (34.29)
n = 39
n = 78
Psoriasis-related nonbiologic, n (%)
2 (5.1%)
2 (2.6%)
Other emollients and protectives, n (%)
0
2 (2.6%)
BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; IQR, interquartile range; PASI, Psoriasis Area and Severity Index; ppIGA, palmoplantar Investigator’s Global Assessment; ppPASI, palmoplantar PASI; ppQLI, palmoplantar Quality-of-Life Instrument; q8w, every 8 weeks; SD, standard deviation; WPAI:PSO, Work Productivity and Activity Impairment: Psoriasis.
