TABLE 1.
Summary of Patient Baseline Characteristics
| CHARACTERISTIC | TEPILAMIDE FUMARATE | Placebo (N=102) | Total (n=406) | ||
|---|---|---|---|---|---|
| 400mg QD (N=101) | 400mg BID (N=102) | 600mg BID (N=101) | |||
| Age, years | 48.0 (13.2) | 51.0 (12.3) | 50.2 (13.7) | 49.3 (12.6) | 49.6 (12.7) |
| Male, n (%) | 64 (63) | 62 (61) | 61 (60) | 60 (59) | 247 (61) |
| Race, n (%) | |||||
| White | 93 (93) | 91 (89) | 87 (86) | 92 (90) | 363 (90) |
| Black/AfricanAmerican | 6 (6) | 4 (4) | 10 (10) | 5 (5) | 25 (6) |
| Asian | 1 (1) | 3 (3) | 2 (2) | 1 (1) | 7 (2) |
| American Indian, Alaska Native | 0 (0) | 2 (2) | 0 (0) | 1 (1) | 3 (1) |
| Native Hawaiian, Pacific Islander | 0 (0) | 1 (1) | 0 (0) | 0 (0) | 1 (< 1) |
| Other | 0 (0) | 1 (1) | 2 (2) | 3 (3) | 6 (1) |
| Ethnicity, n (%) | |||||
| Hispanic/Latino | 62 (61) | 61 (60) | 60 (59) | 55 (54) | 238 (59) |
| Not Hispanic/Latino | 39 (39) | 41 (40) | 41 (41) | 47 (46) | 168 (41) |
| Body mass index, kg/m2 | 30.4 (5.0) | 30.2 (4.7) | 30.7 (4.7) | 30.3 (5.0) | 30.4 (4.8) |
| Baseline Psoriasis Area and Severity Index | 18.4 (6.4) | 18.6 (8.0) | 18.0 (6.7) | 17.3 (6.2) | 18.1 (6.8) |
| Baseline body surface area affected, % | 26 (15) | 25 (15) | 25 (14) | 24 (13) | 25 (14) |
| Baseline Investigator’s Global Assessment, n (%) | |||||
| 3–Moderate | 75 (74) | 77 (75) | 71 (70) | 73 (72) | 296 (73) |
| 4–Severe | 26 (26) | 25 (25) | 30 (30) | 29 (28) | 110 (27) |
| Prior conventional systemic therapy†, n (%) | 64 (63) | 70 (69) | 67 (66) | 64 (63) | 265 (65) |
| Prior biologic therapy, n (%) | 24 (24) | 20 (20) | 21 (21) | 23 (23) | 88 (22) |
BID=twice daily; QD=once daily; SD=standard deviation.
* Data are presented as mean (SD) unless otherwise noted.
† Patients who received phototherapy, systemic psoriasis medical therapy, or a combination.