Table 1.
Patient demographic and clinical characteristics for the intent‐to‐treat population in the COAST‐W studya
| Placebo group (n = 104) | IXEQ2W group (n = 98) | IXEQ4W group (n = 114) | |
|---|---|---|---|
| Age, mean ± SD years | 46.6 ± 12.7 | 44.2 ± 10.8 | 47.4 ± 13.4 |
| Male sex | 87 (83.7) | 75 (76.5) | 91 (79.8) |
| Race | |||
| White | 85 (81.7) | 78 (79.6) | 91 (80.5) |
| Asian | 13 (12.5) | 13 (13.3) | 14 (12.4) |
| Weight, mean ± SD kg | 84.3 ± 17.9 | 79.3 ± 17.3 | 85.5 ± 20.2 |
| <70 kg | 21 (20.2) | 25 (25.5) | 24 (21.1) |
| ≥70 kg | 83 (79.8) | 73 (74.5) | 90 (78.9) |
| Body mass index, mean ± SD kg/m2 | 28.9 ± 5.6 | 27.5 ± 5.4 | 29.4 ± 7.3 |
| Age at onset of axial SpA, mean ± SD years | 27.1 ± 8.8 | 28.1 ± 10 | 28.9 ± 9.6 |
| Duration of symptoms since axial SpA onset, mean ± SD years | 19.9 ± 11.6 | 16.5 ± 9.6 | 18.8 ± 11.6 |
| Duration of disease since axial SpA diagnosis, mean ± SD years | 13.0 ± 10.5 | 11.7 ± 8.8 | 10.1 ± 7.8 |
| Use of DMARDs | |||
| Methotrexate | 20 (19.2) | 9 (9.2) | 12 (10.5) |
| Sulfasalazine | 13 (12.5) | 16 (16.3) | 17 (14.9) |
| Use of oral corticosteroid | 14 (13.5) | 11 (11.2) | 11 (9.6) |
| Use of NSAIDs | 84 (80.8) | 71 (72.4) | 86 (75.4) |
| Prior TNFi experienceb | |||
| 1 prior TNFi | 62 (59.6) | 66 (68.0) | 70 (61.4) |
| 2 prior TNFi | 42 (40.4) | 31 (32.0) | 44 (38.6) |
| Reason for failing prior TNFic | |||
| Inadequate response to 1 TNFi | 64 (61.5) | 66 (68.0) | 75 (65.8) |
| Inadequate response to 2 TNFi | 32 (30.8) | 20 (20.6) | 26 (22.8) |
| Intolerance of TNFi | 8 (7.7) | 11 (11.3) | 13 (11.4) |
| TNFi washout period, median (minimum–maximum) daysd | 123.5 (31.0–4,053.0) | 143.0 (32.0–3,851.0) | 153.5 (29.0–4,639.0) |
| Baseline C‐reactive protein, mean ± SD mg/liter | 16.0 ± 22.3 | 16.9 ± 19.8 | 20.2 ± 34.3 |
| ≤5.00 mg/liter | 39 (37.5) | 26 (26.5) | 44 (38.6) |
| >5.00 mg/liter | 65 (62.6) | 72 (73.5) | 70 (61.4) |
| ASDAS, mean ± SD | 4.1 ± 0.8 | 4.2 ± 0.8 | 4.2 ± 0.9 |
| BASDAI score, mean ± SD | 7.3 ± 1.3 | 7.5 ± 1.3 | 7.5 ± 1.3 |
| BASFI score, mean ± SD | 7.0 ± 1.7 | 7.4 ± 1.4 | 7.4 ± 1.8 |
| ASAS‐HI score, mean ± SD | 9.0 ± 3.5 | 10.1 ± 3.6 | 10.0 ± 3.7 |
| SF‐36 PCS, mean ± SD | 30.6 ± 7.8 | 27.9 ± 7.3 | 27.5 ± 8.3 |
| SPARCC MRI spine score, mean ± SDe | 6.4 ± 10.2 | 11.1 ± 20.3 | 8.3 ± 16 |
| SPARCC MRI spine score ≥2e | 25 (49.0) | 24 (45.3) | 31 (53.4) |
Except where indicated otherwise, values are the number (%) of patients in the analysis population. IXEQ2W = 80‐mg subcutaneous ixekizumab every 2 weeks; IXEQ4W = 80‐mg subcutaneous ixekizumab every 4 weeks; SpA = spondyloarthritis; DMARDs = disease‐modifying antirheumatic drugs; NSAIDs = nonsteroidal antiinflammatory drugs; ASDAS = Ankylosing Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; BASFI = Bath Ankylosing Spondylitis Functional Index; ASAS‐HI = Assessment of Spondyloarthritis international Society Health Index; SF‐36 = Medical Outcomes Study Short Form 36 health survey; PCS = physical component score; SPARCC = Spondyloarthritis Research Consortium of Canada.
Patients were included regardless of whether they were inadequate responders to or intolerant of tumor necrosis factor inhibitors (TNFi).
If a patient had both an inadequate response to 1 TNFi and an intolerance of another TNFi, that patient was classified as having had an inadequate response to 1 TNFi. Patients in the intolerance category discontinued prior TNFi (1 or 2) due to intolerance only.
Washout period for the last TNFi taken. Data were available for all but 1 IXEQ2W patient.
Data were available for the magnetic resonance imaging (MRI) addendum population only (n = 51 for the placebo group, n = 58 for the IXEQ2W group, and n = 53 for the IXEQ4W group).