Table 1.
Baseline demographics and patient characteristics
| Placebo + NBBM (n = 158) |
CZP 200 mg Q2W + NBBM (n = 159) |
|
|---|---|---|
| Age (years), mean (SD) | 37.4 (10.8) | 37.3 (10.5) |
| Female, n (%) | 82 (52) | 81 (51) |
| HLA-B27 positive, n (%) | 132 (84) | 128 (81) |
| Caucasian, n (%) | 148 (94) | 152 (96) |
| Symptom duration (years), mean (SD) | 8.0 (7.5) | 7.8 (7.7) |
| Time since first diagnosis (years), mean (SD) | 4.0 (5.4) | 3.6 (4.8) |
| ASDAS, mean (SD) | 3.8 (0.9) | 3.8 (0.8) |
| BASDAI score, mean (SD) | 6.8 (1.3) | 6.9 (1.4) |
| BASFI score, mean (SD) | 5.4 (2.2) | 5.4 (2.1) |
| BASMI score, mean (SD) | 2.8 (1.4) | 3.0 (1.3) |
| CRP (mg/L), mean (SD) | 15.8 (17.7) | 15.8 (17.8) |
| Elevated CRP at baseline (>ULN), n (%) | 83 (53) | 89 (56) |
| MRI/CRP classification, n (%) | ||
| MRI+/CRP+ | 42 (27) | 45 (28) |
| MRI+/CRP− | 76 (48) | 74 (47) |
| MRI−/CRP+ | 39 (25) | 38 (24) |
| Sacroiliac joint MRI SPARCC score, mean (SD) | 8.5 (12.3) | 7.8 (10.8) |
| Sacroiliac joint MRI SPARCC score ≥2, n (%) | 129 (82) | 136 (86) |
| Nocturnal spinal pain score, mean (SD) | 6.6 (2.1) | 6.6 (2.3) |
| Past treatment,a n (%) | ||
| NSAIDs | 144 (91) | 143 (90) |
| DMARDsb | 46 (29) | 44 (28) |
| Tumour necrosis factor inhibitors | 11 (7) | 7 (4) |
| Concomitant treatment, n (%) | ||
| NSAIDs | 138 (87) | 138 (87) |
| DMARDs | 48 (30) | 55 (35) |
| Systemic corticosteroids | 26 (17) | 27 (17) |
Randomised set (N = 317). All patient-reported outcomes were assessed using a numerical rating scale (0–10), with higher numbers indicating poorer outcomes. aMedications with an end date before the baseline visit; bincludes biologic DMARDs and conventional synthetic DMARDs. ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, BASMI Bath Ankylosing Spondylitis Metrology Index, CRP C-reactive protein, CZP certolizumab pegol, DMARD disease-modifying antirheumatic drug, HLA-B27 human leukocyte antigen B27, MRI magnetic resonance imaging, NBBM non-biologic background medication, NSAID non-steroidal anti-inflammatory drug, Q2W every 2 Weeks, SD standard deviation, SPARCC Spondyloarthritis Research Consortium of Canada, ULN upper limit of normal (9.99 mg/L)