Table 1.
Baseline patient demographics and clinical characteristics (ITT population)
| Placebo (n = 44) | Apremilast 30 mg BID (n = 46) | |
|---|---|---|
| Age, years | ||
| N | 44 | 46 |
| Mean (SD) | 54.7 (11.68) | 54.9 (11.30) |
| Sex, n (%) | ||
| Male | 11 (25.0) | 10 (21.7) |
| Female | 33 (75.0) | 36 (78.3) |
| BMI, kg/m2 | ||
| N | 44 | 46 |
| Mean (SD) | 25.33 (5.309) | 24.37 (3.732) |
| Tobacco use, n (%) | ||
| User | 38 (86.4) | 37 (80.4) |
| Non-user | 6 (13.6) | 9 (19.6) |
| Duration of PPP, years | ||
| N | 44 | 46 |
| Mean (SD) | 7.53 (9.026) | 7.34 (8.627) |
| PPPASI score categories at randomization, n (%) | ||
| ≤ 20 | 14 (31.8) | 16 (34.8) |
| ≥ 21 to ≤ 30 | 19 (43.2) | 18 (39.1) |
| ≥ 31 | 11 (25.0) | 12 (26.1) |
| PPSI total score | ||
| N | 44 | 46 |
| Mean (SD) | 8.2 (1.5) | 8.3 (1.5) |
| PGA, n (%) | ||
| 2 | 1 (2.3) | 3 (6.5) |
| 3 | 24 (54.5) | 16 (34.8) |
| 4 | 17 (38.6) | 21 (45.7) |
| 5 | 2 (4.5) | 6 (13.0) |
| Pruritus VAS | ||
| N | 42 | 46 |
| Mean (SD) | 57.0 (27.8) | 50.3 (31.6) |
| Pain VAS | ||
| N | 42 | 46 |
| Mean (SD) | 50.3 (30.0) | 45.4 (31.9) |
| DLQI total score | ||
| N | 43 | 46 |
| Mean (SD) | 7.2 (4.7) | 7.5 (4.9) |
| Focal infection status at randomization, n (%) | ||
| Presence | 32 (72.7) | 32 (69.6) |
| Absence | 12 (27.3) | 14 (30.4) |
APR apremilast 30 mg twice daily, BMI body mass index, PBO placebo, PPP palmoplantar pustulosis, PPPASI Palmoplantar Pustular Area and Severity Index, SD standard deviation