Baseline demographics and disease characteristics, COAST-V and COAST-W (intent-to-treat population).
| COAST-V (bDMARD-naïve) | COAST-W (TNFi-experienced) | ||||||
|---|---|---|---|---|---|---|---|
| PBO | ADA | IXE Q4W | IXE Q2W | PBO | IXE Q4W | IXE Q2W | |
| N = 87 | N = 90 | N = 81 | N = 83 | N = 104 | N = 114 | N = 98 | |
| Age, yrs | 42.7 (12.0) | 41.8 (11.4) | 41.0 (12.1) | 41.3 (11.2) | 46.6 (12.7) | 47.4 (13.4) | 44.2 (10.8) |
| Male, n (%) | 71 (82.6)a | 73 (81.1) | 68 (84.0) | 64 (77.1) | 87 (83.7) | 91 (79.8) | 75 (76.5) |
| BMI, kg/m2 | 27.6 (5.7) | 26.6 (5.6) | 25.8 (4.0) | 25.9 (6.9) | 28.9 (5.6) | 29.4 (7.3) | 27.5 (5.4) |
| Race, n (%) | |||||||
| Asian | 28 (32.6)a | 29 (32.2) | 25 (30.9) | 25 (30.1) | 13 (12.5) | 14 (12.4)a | 13 (13.3) |
| White | 52 (60.5)a | 57 (63.3) | 52 (64.2) | 52 (62.7) | 85 (81.7) | 91 (80.5)a | 78 (79.6) |
| Age of onset of r-axSpA, yrs | 26.4 (8.4) | 26.5 (8.6) | 25.4 (7.7) | 25.8 (8.2) | 27.1 (8.8) | 28.9 (9.6) | 28.1 (10.0) |
| Duration of symptoms, yrs | 16.6 (10.1) | 15.6 (9.3) | 15.8 (11.2) | 15.8 (10.6) | 19.9 (11.6) | 18.8 (11.6) | 16.5 (9.6) |
| CRP level at baseline, mg/L | 16.0 (21.0) | 12.5 (17.6) | 12.2 (13.3) | 13.4 (15.3) | 16.0 (22.3) | 20.2 (34.3) | 17.0 (19.8) |
| BASDAI baseline | 6.8 (1.2) | 6.7 (1.5) | 6.8 (1.3) | 6.7 (1.6) | 7.3 (1.3) | 7.5 (1.3) | 7.5 (1.3) |
| ASDAS baseline | 3.9 (0.7) | 3.7 (0.8) | 3.7 (0.7) | 3.8 (0.8) | 4.1 (0.8) | 4.2 (0.9) | 4.2 (0.8) |
| SF-36 PCS baseline | 32.0 (8.3) | 33.5 (8.3) | 34.0 (7.5) | 34.1 (7.6) | 30.6 (7.8) | 27.5 (8.3) | 27.9 (7.3) |
| SF-36 MCS baseline | 49.8 (10.8) | 48.4 (12.4) | 50.4 (12.3) | 46.3 (12.6) | 46.2 (12.6) | 45.9 (12.3) | 44.5 (12.7) |
| ASAS HI baseline | 8.1 (3.5) | 8.2 (3.7) | 7.5 (3.3) | 8.4 (3.6) | 9.0 (3.5) | 10.0 (3.7) | 10.1 (3.6) |
| ASAS HI > 5 baseline, n (%) | 64 (73.6) | 67 (74.4) | 54 (66.7) | 68 (81.9) | 84 (80.8) | 99 (86.8) | 87 (88.8) |
| EQ-5D-5L UK population index score | 0.52 (0.22) | 0.53 (0.22) | 0.57 (0.19) | 0.52 (0.21) | 0.45 (0.22) | 0.38 (0.24) | 0.39 (0.23) |
Values are mean (SD) unless otherwise specified.
↵a Data missing. ADA: adalimumab; ASAS HI: Assessment of Spondyloarthritis international Society Health Index; ASDAS: Ankylosing Spondylitis Disease Activity Score; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; bDMARD: biologic disease-modifying antirheumatic drugs; CRP: C-reactive protein; EQ-5D-5L: 5-level EuroQol-5 Dimension; IXE: ixekizumab; IXE Q2W: IXE dosed every 2 weeks; IXE Q4W: IXE dosed every 4 weeks; MCS: mental component score; PBO: placebo; PCS: physical component score; r-axSpA: radiographic axial spondyloarthritis; SF-36: 36-item Short Form Health Survey; TNFi: tumor necrosis factor inhibitors.