Table 1.
Demographics and disease characteristics for patients in COAST-Y
| Lead-in period (N=773) | Randomised withdrawal-retreatment period (N=155) | ||||
| All entered patients N=773 |
Withdrawn to placebo N=53 |
IXE Q4W N=48 |
IXE Q2W N=54 |
Combined IXE N=102 |
|
| Baseline demographics at week 0 | |||||
| Age (years) | 43.2 (12.3) | 38.5 (12.7) | 36.5 (9.7) | 38.4 (10.8) | 37.5 (10.3) |
| Sex, n (%) | |||||
| Male | 551 (71%) | 38 (72%) | 38 (79%) | 40 (74%) | 78 (76%) |
| Race, n (%) | |||||
| White | 562 (73%) | 35 (66%) | 31 (65%) | 31 (57%) | 62 (61%) |
| Asian | 155 (20%) | 13 (25%) | 15 (31%) | 15 (28%) | 30 (29%) |
| Other | 54 (7%) | 5 (9%) | 2 (4%) | 8 (15%) | 10 (10%) |
| BMI (kg/m2) | 27.5 (5.4) | 25.5 (3.9) | 25.9 (4.5) | 25.9 (4.7) | 25.9 (4.6) |
| axSpA symptom duration (years) | 15.5 (10.3) | 12.6 (9.6) | 12.6 (7.5) | 12.9 (8.6) | 12.7 (8.0) |
| axSpA diagnosis duration (years) | 8.3 (8.0) | 6.6 (7.5) | 7.1 (7.0) | 7.6 (8.4) | 7.4 (7.7) |
| HLA-B27 positive, n (%) | 643 (84%) | 45 (85%) | 43 (90%) | 49 (91%) | 92 (90%) |
| csDMARDs use, n (%) | 275 (36%) | 21 (40%) | 18 (38%) | 24 (44%) | 42 (41%) |
| NSAID use, n (%) | 682 (88%) | 50 (94%) | 44 (92%) | 51 (94%) | 95 (93%) |
| Prior TNFi use, n (%)* | |||||
| 0 | 537 (70%) | 44 (83%) | 39 (81%) | 46 (85%) | 85 (83%) |
| 1 | 158 (20%) | 9 (17%) | 3 (6%) | 8 (15%) | 11 (11%) |
| 2 | 78 (10%) | 0 | 6 (13%) | 0 | 6 (6%) |
| Originating study, n (%) | |||||
| COAST-V (r-axSpA, bDMARD-naïve) | 291 (38%) | 24 (45%) | 25 (52%) | 22 (41%) | 47 (46%) |
| COAST-W (r-axSpA, TNFi-experienced) | 236 (31%) | 9 (17%) | 9 (19%) | 8 (15%) | 17 (17%) |
| COAST-X (nr-axSpA, bDMARD-naïve) | 246 (32%) | 20 (38%) | 14 (29%) | 24 (44%) | 38 (37%) |
| Disease characteristics at week 0 | |||||
| C-reactive protein (mg/L) | 4.5 (6.1) | 3.5 (8.8)† | 2.9 (5.8) | 2.1 (2.2) | 2.5 (4.3) |
| ≤5 mg/L, n (%) | 548 (71%) | 45 (85%) | 43 (90%) | 48 (89%) | 91 (89%) |
| >5 mg/L, n (%) | 225 (29%) | 8 (15%) | 5 (10%) | 6 (11%) | 11 (11%) |
| ASDAS score | 2.3 (0.9) | 1.3 (0.5) | 1.3 (0.6) | 1.3 (0.5) | 1.3 (0.5) |
| ASDAS LDA (<2.1), n (%) | 344 (45%) | 48 (91%) | 44 (92%) | 52 (96%) | 96 (94%) |
| ASDAS ID (<1.3), n (%) | 123 (16%) | 36 (68%) | 30 (63%) | 31 (57%) | 61 (60%) |
| BASDAI score | 3.9 (2.3) | 1.3 (1.1) | 1.4 (1.1) | 1.6 (1.2) | 1.5 (1.1) |
| BASDAI spinal pain‡ | 4.2 (2.5) | 1.5 (1.2) | 1.7 (1.5) | 1.7 (1.3) | 1.7 (1.4) |
| BASDAI morning stiffness§ | 3.5 (2.4) | 1.1 (1.1) | 1.1 (1.1) | 1.2 (1.3) | 1.2 (1.2) |
| PatGA | 4.1 (2.5) | 1.6 (1.9) | 1.6 (1.6) | 1.6 (1.3) | 1.6 (1.4) |
| BASFI score | 3.8 (2.5) | 1.1 (1.1) | 1.2 (1.1) | 1.2 (1.2) | 1.2 (1.1) |
| BASMI score | 3.5 (1.6) | 2.7 (1.2) | 2.7 (1.3) | 2.7 (1.4) | 2.7 (1.3) |
| Disease characteristics at week 24 | |||||
| C-reactive protein (mg/L) | – | 2.0 (2.4) | 3.1 (4.0) | 2.1 (1.8) | 2.6 (3.1) |
| ≤5 mg/L, n (%) | – | 46 (87%) | 38 (79%) | 49 (91%) | 87 (85%) |
| >5 mg/L, n (%) | – | 7 (13%) | 10 (21%) | 5 (9%) | 15 (15%) |
| ASDAS score | – | 1.2 (0.5) | 1.3 (0.5) | 1.2 (0.4) | 1.2 (0.5) |
| ASDAS LDA (<2.1), n (%) | – | 50 (94%) | 43 (90%) | 54 (100%) | 97 (95%) |
| ASDAS ID (<1.3), n (%) | – | 37 (70%) | 32 (67%) | 34 (63%) | 66 (65%) |
| BASDAI score | – | 1.2 (1.1) | 1.2 (1.0) | 1.3 (1.1) | 1.2 (1.0) |
| BASDAI spinal pain† | – | 1.5 (1.7) | 1.4 (1.5) | 1.4 (1.2) | 1.4 (1.4) |
| BASDAI morning stiffness‡ | – | 1.1 (1.3) | 0.8 (1.0) | 0.9 (0.9) | 0.8 (0.9) |
| PatGA | – | 1.3 (1.4) | 1.5 (1.4) | 1.3 (1.2) | 1.4 (1.3) |
| BASFI score | – | 1.1 (1.1) | 1.2 (1.2) | 1.0 (1.1) | 1.1 (1.2) |
| BASMI score | – | 2.5 (1.3) | 2.7 (1.3) | 2.8 (1.4) | 2.8 (1.3) |
Data are presented as mean (SD), unless otherwise specified.
*Excludes adalimumab taken as study drug in COAST-V.
†One patient in the withdrawn to placebo group had a high CRP of 61.5 mg/L at week 0, resulting in an increased mean CRP for this treatment group (maximum CRP level was 32.3 for IXE Q4W and 12.3 for IXE Q2W).
‡BASDAI Question 2.
§Mean of BASDAI Questions 5 and 6.
ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; HLA-B27, human leucocyte antigen B27; IXE, ixekizumab; nr-axSpA, non-radiographic axial spondyloarthritis; NSAID, non-steroidal anti-inflammatory drug; PatGA, Patient Global Assessment of Disease Activity; Q2W, every 2 weeks; Q4W, every 4 weeks; r-axSpA, radiographic axial spondyloarthritis; TNFi, tumour necrosis factor inhibitor.