Table 1. Demographic and Baseline Disease Characteristics of Patients With Moderate to Severe Psoriasis in a Phase 2b Study for Zasocitinib.
| Characteristic | No. (%) | |||||
|---|---|---|---|---|---|---|
| Placebo (n = 52) | Zasocitinib, once daily | Total (N = 259) | ||||
| 2 mg (n = 50) | 5 mg (n = 52) | 15 mg (n = 53) | 30 mg (n = 52) | |||
| Demographic | ||||||
| Age, mean (SD), y | 49 (13) | 46 (14) | 45 (14) | 46 (13) | 49 (11) | 47 (13) |
| Sex | ||||||
| Female | 21 (40) | 12 (24) | 11 (21) | 19 (36) | 19 (37) | 82 (32) |
| Male | 31 (60) | 38 (76) | 41 (79) | 34 (64) | 33 (63) | 177 (68) |
| Race | ||||||
| Asian | 5 (10) | 3 (6) | 7 (14) | 2 (4) | 3 (6) | 20 (8) |
| Black or African American | 2 (4) | 4 (8) | 4 (8) | 3 (6) | 4 (8) | 17 (7) |
| White | 44 (85) | 43 (86) | 40 (77) | 46 (87) | 42 (81) | 215 (83) |
| Weight, mean (SD), kg | 88 (16) | 94 (17) | 90 (19) | 93 (17) | 90 (18) | 91 (17) |
| BMI, mean (SD) | 31 (5) | 31 (5) | 30 (6) | 32 (5) | 30 (5) | 31 (5) |
| Clinical | ||||||
| Duration of psoriasis, median (range), y | 9 (6–16) | 12 (6-17) | 12 (7-21) | 12 (6-27) | 16 (8-27) | 12 (6-22) |
| Prior treatment with biologics | 8 (15) | 8 (16) | 8 (15) | 9 (17) | 8 (15) | 41 (16) |
| PASI score, mean (SD)a | 18 (8) | 18 (7) | 19 (6) | 16 (5) | 18 (6) | 18 (6) |
| PGA score, mean (SD)b | 3 (0) | 3 (0) | 3 (0) | 3 (0) | 3 (0) | 3 (0) |
| PGA scoreb | ||||||
| 3: Moderate | 41 (79) | 30 (60) | 34 (65) | 40 (75) | 42 (81) | 187 (72) |
| 4: Severe | 11 (21) | 20 (40) | 18 (35) | 13 (25) | 10 (19) | 72 (28) |
| BSA, mean (SD), %c | 21 (14) | 25 (16) | 23 (12) | 18 (10) | 22 (14) | 22 (13) |
| DLQI score, mean (SD)d | 12 (7) | 10 (6) | 13 (7) | 12 (7) | 13 (7) | 12 (7) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician’s Global Assessment.
The PASI is a composite score ranging from 0 to 72 that considers the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions, with adjustments for the percentage of the BSA involved for each body region and proportion of the body region to the whole body. For PASI calculation, the 4 main body regions were assessed: the head, the trunk, and the upper and lower extremities, corresponding to 10%, 20%, 30%, and 40% of the total body area, respectively. The area of psoriatic involvement of these 4 main regions was given a numerical value: 0 indicating no involvement, 1 indicating less than 10% psoriatic involvement, 2 indicating 10% to less than 30% psoriatic involvement, 3 indicating 30% to less than 50% psoriatic involvement, 4 indicating 50% to less than 70% psoriatic involvement, 5 indicating 70% to less than 90% psoriatic involvement, and 6 indicating 90% to 100% psoriatic involvement.27
The PGA score is a 5-point morphological assessment of overall disease severity. For the purposes of this study, the PGA score ranged from 0 to 4, with 0 representing clear skin and 4 representing severe disease.
The overall BSA affected by plaque psoriasis was evaluated from 0% to 100%. The palmar surface of 1 hand (using the patient’s hand and including the fingers) represented 1% of the total BSA.
The DLQI is a 10-question validated questionnaire structured with each question having 4 alternative responses: not at all, a little, a lot, or very much, with corresponding scores of 0, 1, 2, and 3, respectively. The questionnaire also includes a “not relevant” answer scored as 0. The DLQI is calculated by summing the score of each question, resulting in a maximum of 30 and minimum of 0. The higher the score, the greater the impairment of quality of life.28