Table 1.
Total N=203 |
Placebo n=66 |
Deucravacitinib | ||
6 mg once a day n=70 |
12 mg once a day n=67 |
|||
Demographics | ||||
Age, years, mean (SD) | 49.8 (13.5) | 48.5 (13.2) | 50.5 (13.7) | 50.5 (13.8) |
Female, n (%) | 104 (51.2) | 40 (60.6) | 30 (42.9) | 34 (50.7) |
White, n (%) | 199 (98.0) | 65 (98.5) | 67 (95.7) | 67 (100.0) |
Body weight, kg, mean (SD) | 88.6 (19.0) | 90.5 (22.7) | 86.4 (16.6) | 89.1 (17.3) |
<90 kg, n (%) | 104 (51.2) | 33 (50.0) | 36 (51.4) | 35 (52.2) |
≥90 kg, n (%) | 99 (48.8) | 33 (50.0) | 34 (48.6) | 32 (47.8) |
BMI, kg/m2, mean (SD) | 30.4 (6.0) | 31.2 (7.2) | 29.6 (5.4) | 30.3 (5.4) |
Prior/concomitant medications | ||||
Use of csDMARD, n (%) | 132 (65.0) | 44 (66.7) | 45 (64.3) | 43 (64.2) |
Use of methotrexate, n (%) | 111 (54.7) | 39 (59.1) | 35 (50.0) | 37 (55.2) |
Weekly dose, mg, mean (SD) | 16.5 (4.7) | 16.7 (4.8) | 16.4 (4.9) | 16.5 (4.6) |
Prior TNFi use, n (%) | ||||
1 | 31 (15.3) | 11 (16.7) | 12 (17.1) | 8 (11.9) |
2 | 1 (0.5) | 0 | 0 | 1 (1.5) |
Oral steroid use, n (%) | 25 (12.3) | 12 (18.2) | 7 (10.0) | 6 (9.0) |
Daily dose, mg, mean (SD) | 4.0 (1.7) | 4.4 (1.9) | 3.7 (1.3) | 3.5 (1.6) |
Disease parameters | ||||
Psoriatic arthritis disease duration from diagnosis, years, median (range) | 4.5 (0.1–42.8) | 4.5 (0.6–22.9) | 5.3 (0.1–42.8) | 3.8 (0.6–27.7) |
Tender joint count, mean (SD) | 18.1 (10.7) | 16.9 (9.8) | 18.1 (10.3) | 19.4 (11.8) |
Swollen joint count, mean (SD) | 11.3 (7.9) | 10.5 (7.7) | 11.9 (7.0) | 11.3 (9.0) |
Pain in mm, VAS, mean (SD)* | 64.1 (18.7) | 64.9 (18.2) | 63.6 (21.7) | 63.8 (15.9) |
HAQ-DI, mean (SD) | 1.3 (0.6) | 1.3 (0.6) | 1.3 (0.6) | 1.3 (0.6) |
hs-CRP, mg/L, mean (SD) | 18.2 (29.0) | 20.4 (39.1) | 17.6 (23.6) | 16.5 (21.7) |
Psoriasis with ≥3% BSA, n (%) | 165 (81.3) | 54 (81.8) | 59 (84.3) | 52 (77.6) |
PASI-75 score in patients with ≥3% BSA | ||||
Mean (SD) | 8.5 (6.7) | 9.1 (7.4) | 8.5 (6.8) | 7.9 (5.9) |
Range | 1.2–33.8 | 1.2–31.4 | 1.6–33.8 | 1.4–31.8 |
Enthesitis, Leeds Index ≥1, n (%) | 96 (47.3) | 31 (47.0) | 39 (55.7) | 26 (38.8) |
Leeds Index in those with enthesitis, mean (SD) | 2.7 (1.6) | 2.8 (1.7) | 2.5 (1.6) | 2.9 (1.4) |
Dactylitis, n (%) | 79 (38.9) | 25 (37.9) | 30 (42.6) | 24 (35.8) |
*VAS scale ranges from 0–100 mm, with higher values indicating worse pain.
BMI, body mass index; BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; hs-CRP, high-sensitivity C reactive protein; PASI-75, 75% improvement from baseline in Psoriasis Area and Severity Index; TNFi, tumour necrosis factor inhibitor; VAS, Visual Analogue Scale.