Table 1.
Baseline patient demographics and patient characteristics when subdivided according to background cDMARD use and treatment regimen
| Any background cDMARD | Background MTX only | No background cDMARDs | |||||||
| PBO n=52 |
IXEQ4W n=60 | IXEQ2W n=73 | PBO n=40 |
IXEQ4W n=48 | IXEQ2W n=61 | PBO n=66 |
IXEQ4W n=62 | IXEQ2W n=50 | |
| Male, n (%) | 26 (50.0) | 31 (51.7) | 29 (39.7) | 21 (52.5) | 25 (52.1) | 26 (42.6) | 30 (45.5) | 32 (51.6) | 21 (42.0) |
| Age (years), mean (SD) | 53.1 (9.64) | 52.3 (14.2) | 49.8 (11.6) | 54.3 (9.3) | 53.3 (13.4) | 48.9 (11.3)* | 50.2 (10.8) | 52.9 (13) | 54.6 (11.8)* |
| White, n (%) | 47 (90.4) | 54 (90.0) | 63 (87.5) | 36 (90.0) | 43 (89.6) | 54 (90.0) | 61 (92.4) | 57 (91.9) | 50 (100) |
| n=52 | n=60 | n=72 | n=40 | n=48 | n=60 | n=66 | n=62 | n=50 | |
| Weight (kg), mean (SD) | 91.2 (20.8) | 93.4 (24.0) | 83.8 (18.7)* | 92.2 (21.2) | 93.6 (24.3) | 83.9 (18.5)* | 90.9 (23.2) | 86.4 (19.6) | 87.3 (23.3) |
| BMI (kg/m2), mean (SD) | 31.6 (7.94) | 32.5 (7.71) | 29.7 (5.95) | 32.0 (8.13) | 32.6 (7.62) | 29.6 (6.02) | 31.5 (7.34) | 29.4 (6.21) | 30.7 (7.82) |
| n=52 | n=60 | n=71 | n=40 | n=48 | n=60 | n=66 | n=62 | n=50 | |
| BMI (kg/m2) group, n (%) Obese (≥30 to <40) | 20 (38.5) | 25 (41.7) | 26 (36.6) | 16 (40.0) | 18 (37.5) | 22 (36.7) | 23 (34.8) | 26 (41.9) | 17 (34.0) |
| n=52 | n=60 | n=71 | n=40 | n=48 | n=60 | n=66 | n=62 | n=50 | |
| Prior TNFi experience, n (%) | |||||||||
| 1 TNFi IR | 32 (61.5) | 37 (61.7) | 37 (50.7) | 23 (57.5) | 28 (58.3) | 30 (49.2) | 36 (54.5) | 34 (54.8) | 28 (56.0) |
| 2 TNFi IR | 17 (32.7) | 19 (31.7) | 28 (38.4) | 14 (35.0) | 16 (33.3) | 24 (39.3) | 24 (36.4) | 22 (35.5) | 18 (36.0) |
| TNFi intolerance | 3 (5.8) | 4 (6.7) | 8 (11.0) | 3 (7.5) | 4 (8.3) | 7 (11.5) | 6 (9.1) | 6 (9.7) | 4 (8.0) |
| Time since PsA onset (years), mean (SD) | 11.3 (8.00) | 11.9 (10.2) | 10.9 (6.36) | 11.4 (8.01) | 12.0 (10.7) | 11.0 (6.52) | 11.1 (8.85) | 15.7 (10.8)** | 12.4 (8.82) |
| Tender joint count 68 joints, mean (SD) | 21.9 (13.9) | 20.8 (15.0) | 23.8 (16.3) | 22.6 (14.2) | 20.8 (15.2) | 21 (13.5) | 23.8 (17.9) | 23.2 (13.1) | 26.8 (18.6) |
| n=52 | n=60 | n=73 | n=40 | n=48 | n=61 | n=66 | n=61 | n=50 | |
| Swollen joint count 66 joints, mean (SD) | 10.3 (7.37) | 13.7 (13.3) | 13.1 (11.5) | 10.3 (7.52) | 13.1 (12.1) | 11.9 (8.99) | 10.2 (7.39) | 12.4 (8.67) | 14.1 (11.6)* |
| n=52 | n=60 | n=73 | n=40 | n=48 | n=61 | n=66 | n=61 | n=50 | |
| HAQ-DI total score, mean (SD) | 1.14 (0.69) | 1.13 (0.61) | 1.14 (0.64) | 1.26 (0.69) | 1.11 (0.63) | 1.10 (0.63) | 1.31 (0.65) | 1.23 (0.62) | 1.29 (0.62) |
| n=52 | n=59 | n=72 | n=40 | n=47 | n=60 | n=65 | n=61 | n=48 | |
| CRP (mg/L), mean (SD) | 13.0 (26.3) | 16.0 (23.0) | 11.2 (18.8) | 15.7 (29.6) | 16.7 (24.6) | 12.0 (20.2) | 11.4 (12.6) | 17.9 (31.3) | 17.0 (34.1) |
| n=50 | n=58 | n=73 | n=38 | n=47 | n=61 | n=66 | n=61 | n=50 | |
| DAS28-CRP, mean (SD) | 4.87 (1.14) | 5.01 (1.12) | 5.05 (1.02) | 4.96 (1.11) | 5.11 (1.02) | 4.99 (0.96) | 5.09 (1.04) | 5.19 (1.00) | 5.26 (1.27) |
| n=51 | n=57 | n=73 | n=39 | n=46 | n=61 | n=66 | n=61 | n=48 | |
| DAPSA, mean (SD) | 46.2 (19.9) | 49.6 (26.3) | 50.9 (26.6) | 47.5 (19.5) | 49.3 (24.9) | 46.8 (21.4) | 48.3 (24.0) | 51.1 (18.6) | 57.1 (30.4) |
| n=51 | n=57 | n=73 | n=39 | n=46 | n=61 | n=66 | n=61 | n=48 | |
| Current plaque psoriasis, n (%) | 45 (86.5) | 57 (95.0) | 66 (90.4) | 34 (85.0) | 45 (93.8) | 57 (93.4) | 63 (95.5) | 61 (98.4) | 47 (94.0) |
The overall number of patients is provided at the top of each column. The actual number of patients evaluable is also provided for each measure that is missing at least one patient.
*p<0.05 versus PBO, **p<0.01 versus PBO.
BMI, body mass index; cDMARD, conventional disease-modifying antirheumatic drug; CRP, C-reactive protein; DAPSA, Disease Activity Index for Psoriatic Arthritis; DAS28-CRP, 28-joint Disease Activity Score using C-reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responder; IXEQ2W, ixekizumab every 2 weeks; IXEQ4W, ixekizumab every 4 weeks; MTX, methotrexate; n, number of patients; PBO, placebo; PsA, psoriatic arthritis; SD, standard deviation; TNFi, tumour necrosis factor inhibitor.