Table 1.
Patient demographic and clinical characteristics at baseline (n = 317)a
| Placebo plus NBBM group (n = 158) | CZP plus NBBM, 200 mg every 2 weeks (n = 159) | |
|---|---|---|
| Demographic characteristic | ||
| Age, mean ± SD years | 37.4 ± 10.8 | 37.3 ± 10.5 |
| Female | 82 (51.9) | 81 (50.9) |
| HLA–B27 positive | 132 (83.5) | 128 (80.5) |
| White race | 148 (93.7) | 152 (95.6) |
| Geographic region | ||
| North America | 13 (8.2) | 15 (9.4) |
| Europe | 130 (82.3) | 130 (81.8) |
| Asia/Australia | 15 (9.5) | 14 (8.8) |
| Disease characteristic | ||
| Symptom duration, mean ± SD years | 8.0 ± 7.5 | 7.8 ± 7.7 |
| Time since first diagnosis, years | ||
| Mean ± SD | 4.0 ± 5.4 | 3.6 ± 4.8 |
| Median (range) | 2.1 (0.0–38.2) | 1.7 (0.1–29.2) |
| CRP, mean ± SD mg/liter | 15.8 ± 17.7 | 15.8 ± 17.8 |
| Elevated CRP at baseline (CRP > ULN) | 83 (52.5) | 89 (56.0) |
| 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 |
| Sacroiliac joint SPARCC score, mean ± SD | 8.5 ± 12.3 | 7.8 ± 10.8 |
| Nocturnal spinal pain score, mean ± SD (scale 0–10) | 6.6 ± 2.1 | 6.6 ± 2.3 |
| ASQoL score, mean ± SD | 12.1 ± 4.3 | 11.7 ± 4.3 |
| Uveitis | ||
| History | 25 (15.8) | 22 (13.8) |
| Current | 11 (7.0) | 6 (3.8) |
| Enthesitis | 122 (77.2) | 125 (78.6) |
| MASES, mean ± SD | 4.8 ± 3.5 | 4.8 ± 3.2 |
| ASAS‐NSAID score, mean ± SD | 66.3 ± 48.7 | 69.6 ± 48.0 |
| MRI/CRP stratificationb | ||
| MRI+/CRP+ | 42 (26.6) | 45 (28.3) |
| MRI+/CRP− | 76 (48.1) | 74 (46.5) |
| MRI−/CRP+ | 39 (24.7) | 38 (23.9) |
| Prior and concomitant medications | ||
| NSAIDs | ||
| Prior | 154 (97.5) | 157 (98.7) |
| Concomitant | 138 (87.3) | 138 (86.8) |
| DMARDs | ||
| Prior | 73 (46.2) | 77 (48.4) |
| Concomitant | 48 (30.4) | 55 (34.6) |
| Corticosteroids | ||
| Prior | 36 (22.8) | 31 (19.5) |
| Concomitant | 16 (10.1) | 16 (10.1) |
| Anti‐TNF medication, any prior usage | 11 (7.0) | 7 (4.4) |
Except where indicated otherwise, values are the number (%) of patients in the analysis population. NBBM = nonbiologic background medication; CZP = certolizumab pegol; ULN = upper limit of normal; ASDAS = Ankylosing Spondylitis Disease Activity Score; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index (0–10 scale; higher scores indicate higher disease activity); BASFI = Bath Ankylosing Spondylitis Functional Index (0–10 scale; higher scores indicate worse function); BASMI = Bath Ankylosing Spondylitis Metrology Index (0–10 scale; higher scores indicate more severe spinal mobility impairment); SPARCC = Spondyloarthritis Research Consortium of Canada; ASQoL = ankylosing spondylitis quality of life (0–18 scale; higher scores indicate worse quality of life); MASES = Maastricht Ankylosing Spondylitis Enthesitis Score (0–13 scale; higher scores indicate more severe enthesitis); ASAS‐NSAID score = Assessment of SpondyloArthritis international Society–nonsteroidal antiinflammatory drug score (0–100 scale; higher scores indicate greater NSAID intake); DMARDs = disease‐modifying antirheumatic drugs; anti‐TNF = anti–tumor necrosis factor.
Three patients were classified as magnetic resonance imaging negative (MRI−)/C‐reactive protein negative (CRP−) and were determined to be protocol deviations.