Characteristic | Secukinumab 300 mg with LD (n=222) | Secukinumab 150 mg with LD (n=220) | Secukinumab 150 mg without LD (n=222) | Placebo (n=332) | Total (n=996) |
Age (years), mean (SD) | 48.9 (12.8) | 48.4 (12.9) | 48.8 (11.8) | 49.0 (12.1) | 48.8 (12.4) |
Female, n (%) | 114 (51.4) | 109 (49.5) | 102 (45.9) | 171 (51.5) | 496 (49.8) |
Weight (kg) | 81.9 (16.9) | 83.3 (19.6) | 84.1 (20.5) | 84.1 (19.6) | 83.4 (19.2) |
Race, n (%) | |||||
White | 184 (82.9) | 178 (80.9) | 180 (81.1) | 274 (82.5) | 816 (81.9) |
Asian | 24 (10.8) | 29 (13.2) | 27 (12.2) | 33 (9.9) | 113 (11.3) |
American Indian or Alaska Native | 1 (0.5) | 1 (0.5) | 6 (2.7) | 2 (0.6) | 10 (1.0) |
Black or African American | 1 (0.5) | 0 (0.0) | 0 (0.0) | 5 (1.5) | 6 (0.6) |
Unknown | 0 (0.0) | 0 (0.0) | 2 (0.9) | 2 (0.6) | 4 (0.4) |
Other | 12 (5.4) | 12 (5.5) | 7 (3.2) | 16 (4.8) | 47 (4.7) |
Time since first diagnosis of psoriatic disease (years), mean (SD) | 6.7 (8.3) | 6.7 (7.1) | 6.2 (6.1) | 6.6 (7.6) | 6.6 (7.3) |
Number of prior anti-TNF therapies, n (%) | |||||
0 | 154 (69.4) | 155 (70.5) | 158 (71.2) | 234 (70.5) | 701 (70.4) |
1 | 45 (20.3) | 43 (19.5) | 44 (19.8) | 65 (19.6) | 197 (19.8) |
≥2 | 23 (10.4) | 22 (10.0) | 20 (9.0) | 33 (9.9) | 98 (9.8) |
Methotrexate use at randomisation, n (%) | 112 (50.5) | 108 (49.1) | 120 (54.1) | 159 (47.9) | 499 (50.1) |
Systemic glucocorticoid at randomisation, n (%) | 34 (15.3) | 44 (20.0) | 37 (16.7) | 53 (16.0) | 168 (16.9) |
Patients with specific disease characteristics, n (%) | |||||
Psoriasis affecting≥3% of BSA | 110 (49.5) | 125 (56.8) | 117 (52.7) | 162 (48.8) | 514 (51.6) |
Presence of enthesitis | 140 (63.1) | 141 (64.1) | 129 (58.1) | 192 (57.8) | 602 (60.4) |
Presence of dactylitis | 82 (36.9) | 80 (36.4) | 103 (46.4) | 124 (37.3) | 389 (39.1) |
Disease and quality of life scores, mean (SD) | |||||
Tender joint count (78 joints) | 19.8 (15.1) | 21.2 (15.9) | 21.8 (16.0) | 21.2 (16.2) | 21.0 (15.8) |
Swollen joint count (76 joints) | 10.0 (8.0) | 12.1 (10.5) | 11.9 (10.3) | 11.7 (10.8) | 11.5 (10.1) |
DAS28-CRP score | 4.5 (1.0) | 4.7 (1.0) | 4.6 (1.1) | 4.6 (1.1) | 4.6 (1.1) |
HAQ-DI score | 1.2 (0.6) | 1.3 (0.6) | 1.3 (0.7) | 1.3 (0.6) | 1.3 (0.6) |
vdH-mTSS | 12.9 (23.7) | 13.6 (25.9) | 15.3 (37.5) | 15 (38.2) | – |
PsA pain, VAS 0–100 mm | 52.8 (24.8) | 56.5 (22.8) | 54.5 (22.9) | 53.6 (24.5) | 54.3 (23.9) |
Patients’ global assessment of disease activity, VAS 0–100 mm | 55.0 (22.8) | 53.9 (22.6) | 54.6 (23.5) | 52.5 (22.2) | 53.9 (22.7) |
Physician’s global assessment of disease activity, VAS 0–100 mm | 55.4 (18.3) | 57.7 (18.6) | 57.3 (19.2) | 54.3 (20.3) | 55.9 (19.3) |
BSA, body surface area; DAS28-CRP, 28-joint Disease Activity Score using C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; LD, loading dose; PsA, psoriatic arthritis; TNF, tumour necrosis factor; VAS, visual analogue scale; vdH-mTSS, van der Heijde-modified total Sharp score.