Table 1. Baseline Participant Characteristics.
| Characteristics | DERMIS-1 trial | DERMIS-2 trial | ||
|---|---|---|---|---|
| Roflumilast (n = 286) | Vehicle (n = 153) | Roflumilast (n = 290) | Vehicle (n = 152) | |
| Age, mean (SD), y | 47.6 (14.09) | 48.7 (15.77) | 46.9 (15.07) | 47.1 (14.07) |
| Sex, No. (%) | ||||
| Female | 97 (33.9) | 57 (37.3) | 114 (39.3) | 52 (34.2) |
| Male | 189 (66.1) | 96 (62.7) | 176 (60.7) | 100 (65.8) |
| BMI, mean (SD) | 32.0 (9.5) | 31.9 (7.9) | 31.0 (7.0) | 33.5 (13.7) |
| Ethnicity, No. (%)a | ||||
| Hispanic or Latino | 63 (22.0) | 34 (22.2) | 76 (26.2) | 50 (32.9) |
| Not Hispanic or Latino | 223 (78.0) | 119 (77.8) | 213 (73.4) | 102 (67.1) |
| Race, No. (%)a | ||||
| American Indian or Alaska Native | 4 (1.4) | 1 (0.7) | 0 | 1 (0.7) |
| Asian | 21 (7.3) | 11 (7.2) | 20 (6.9) | 9 (5.9) |
| Black or African American | 8 (2.8) | 8 (5.2) | 13 (4.5) | 9 (5.9) |
| Native Hawaiian or Other Pacific Islander | 2 (0.7) | 0 | 3 (1.0) | 1 (0.7) |
| White | 234 (81.8) | 124 (81.0) | 240 (82.8) | 126 (82.9) |
| Not reported | 4 (1.4) | 3 (2.0) | 5 (1.7) | 2 (1.3) |
| Otherb | 11 (3.8) | 5 (3.3) | 8 (2.8) | 4 (2.6) |
| More than 1 race | 2 (0.7) | 1 (0.7) | 1 (0.3) | 0 |
| Psoriasis-affected BSA, mean (SD), %c,d | 6.3 (4.4) | 7.4 (4.8) | 7.1 (4.8) | 7.7 (5.1) |
| IGA scored,e | ||||
| Mean (SD) | 2.9 (0.52) | 2.9 (0.45) | 2.9 (0.48) | 2.9 (0.47) |
| No. (%) | ||||
| 2 (Mild) | 51 (17.8) | 20 (13.1) | 50 (17.2) | 24 (15.8) |
| 3 (Moderate) | 206 (72.0) | 122 (79.7) | 220 (75.9) | 118 (77.6) |
| 4 (Severe) | 29 (10.1) | 11 (7.2) | 20 (6.9) | 10 (6.6) |
| PASI score, mean (SD)d,f | 6.3 (3.15) | 6.8 (3.70) | 6.5 (3.22) | 7.0 (3.52) |
| WI-NRS scoreg | ||||
| Mean (SD) | 5.7 (2.75) | 5.7 (2.84) | 5.8 (2.61) | 6.1 (2.75) |
| ≥4, No. (%) | 218 (76.2) | 115 (75.2) | 229 (79.0) | 116 (76.3) |
| PSD total score, mean (SD)h | 72.1 (42.75) | 73.4 (41.29) | 69.3 (40.66) | 77.4 (41.24) |
| Psoriasis area of involvement, No. (%) | ||||
| Face | 74 (25.9) | 45 (29.4) | 76 (26.2) | 39 (25.7) |
| Genitalia | 51 (17.8) | 21 (13.7) | 46 (15.9) | 19 (12.5) |
| Intertriginous areas | 68 (23.8) | 33 (21.6) | 56 (19.3) | 32 (21.1) |
| Intertriginous IGA (I-IGA) score | ||||
| ≥2, No. (%)i | 63 (22.0) | 32 (20.9) | 53 (18.3) | 31 (20.4) |
| Among patients with mild to severe I-IGA involvement, mean (SD)j | 2.4 (0.70) | 2.5 (0.56) | 2.4 (0.69) | 2.6 (0.62) |
| No. (%) | ||||
| 0 (Clear) | 0 | 0 | 1 (0.3)k | 0 |
| 1 (Almost clear) | 5 (1.7) | 1 (0.7) | 2 (0.7) | 1 (0.7) |
| 2 (Mild) | 33 (11.5) | 16 (10.5) | 25 (8.6) | 13 (8.6) |
| 3 (Moderate) | 27 (9.4) | 16 (10.5) | 27 (9.3) | 17 (11.2) |
| 4 (Severe) | 3 (1.0) | 0 | 1 (0.3) | 1 (0.7) |
Race and ethnicity categories were self-reported by participants from a list of fixed categories, with options to select race as “not reported” or “other” with an option to specify.
Other included participants identifying as Afghanistani, Brazilian, Caribbean, Canadian Indian, Egyptian, Filipino, Guyanese, Hispanic, Latino/Latin, Middle Eastern, South Asian, Vietnamese, and West Indian.
Determined by the patient’s hand method, in which a patient’s hand (including fingers) surface area was assumed to equal 1% of body surface area (BSA).
If affected, palms and soles were treated but not counted toward any efficacy assessments. Scalp was not treated and did not count toward any efficacy assessments.
The Investigator Global Assessment (IGA) is a static evaluation of qualitative overall psoriasis severity assessed on a 5-point scale (0 [clear] to 4 [severe]).7
The Psoriasis Area and Severity Index (PASI) combines assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).8
The Worst Itch Numeric Rating Scale (WI-NRS) is a single item to assess patient-reported severity of the highest intensity of itch during the previous 24 hours on a scale from 0 (no itch) to 10 (worst imaginable itch).9
Patients used the Psoriasis Symptom Diary (PSD) to determine the severity and impact of psoriasis-related signs and symptoms over the past 24 hours, rating each variable in the 16-item assessment on a 0-10 scale for a total score ranging from 0-160, with higher scores indicating greater severity or burden.10
Patients with intertriginous area involvement and with at least mild severity of the intertriginous lesions (I-IGA ≥2) at baseline.
Patients with intertriginous area involvement of at least mild severity (I-IGA ≥2) at baseline using a 5-point scale ranging from 0 (clear) to 4 (severe), evaluating intertriginous areas only.
Patient was noted to have intertriginous involvement at screening, but I-IGA was assessed as clear (0) at baseline and subsequent times. Because the I-IGA score was <2, the patient was not included in the I-IGA analysis population.