Demographics and disease characteristics for patients enrolled in C-OPTIMISE
| Induction period | Patients randomised into maintenance period (n=313) | |||
| All axSpA (n=736) | CZP 200 mg Q2W (n=104) | CZP 200 mg Q4W (n=105) | Placebo (n=104) | |
| Baseline demographics | ||||
| Age, years | ||||
| Mean (SD) | 32.9 (7.0) | 32.6 (7.2) | 32.4 (6.9) | 31.2 (6.6) |
| Range | 18–45 | 18–45 | 18–45 | 18–45 |
| Male, n (%) | 514 (69.8) | 79 (76.0) | 83 (79.0) | 85 (81.7) |
| BMI, kg/m2, mean (SD) | 25.7 (4.9) | 25.1 (4.2) | 25.9 (4.6) | 24.7 (3.6) |
| Race, n (%) | ||||
| Caucasian | 681 (92.5) | 97 (93.3) | 97 (92.4) | 98 (94.2) |
| Asian | 38 (5.2) | 5 (4.8) | 6 (5.7) | 5 (4.8) |
| Other/mixed/missing | 17 (2.3) | 2 (1.9) | 2 (1.9) | 1 (1.0) |
| Geographical region, n (%) | ||||
| North America | 33 (4.5) | 3 (2.9) | 3 (2.9) | 4 (3.8) |
| Western Europe | 91 (12.4) | 10 (9.6) | 9 (8.6) | 8 (7.7) |
| Eastern Europe | 537 (73.0) | 82 (78.8) | 83 (79.0) | 82 (78.8) |
| Asia | 75 (10.2) | 9 (8.7) | 10 (9.5) | 10 (9.6) |
| mNY positive, n (%) | 407 (55.3) | 56 (53.8) | 56 (53.3) | 56 (53.8) |
| Symptom duration, years | ||||
| Mean (SD) | 3.3 (2.2) | 3.8 (2.8) | 3.4 (1.8) | 3.1 (1.6) |
| Median | 3.5 | 3.9 | 3.5 | 3.3 |
| Time since diagnosis, years | ||||
| Mean (SD) | 2.2 (1.7) | 2.5 (1.7) | 2.0 (1.7) | 2.1 (1.7) |
| Median | 1.6 | 2.7 | 1.3 | 1.3 |
| HLA-B27 positive, n (%) | 617 (83.8) | 91 (87.5) | 97 (92.4) | 94 (90.4) |
| CRP >ULN, n (%) | 344 (46.7) | 55 (52.9) | 51 (48.6) | 44 (42.3) |
| Prior TNFi therapy, n (%) | 32 (4.3) | 4 (3.8) | 6 (5.7) | 7 (6.7) |
| History of enthesitis (heel), n (%) | 184 (25.0) | 30 (28.8) | 35 (33.3) | 24 (23.1) |
| History of EAMs, n (%) | ||||
| Uveitis | 111 (15.1) | 16 (15.4) | 20 (19.0) | 17 (16.3) |
| Inflammatory bowel disease | 17 (2.3) | 2 (1.9) | 3 (2.9) | 1 (1.0) |
| Psoriasis | 45 (6.1) | 8 (7.7) | 2 (1.9) | 7 (6.7) |
| Concomitant medication,* n (%) | ||||
| NSAIDs | 618 (84.0) | 85 (81.7) | 92 (87.6) | 85 (82.5) |
| DMARDs | 166 (22.6) | 21 (20.2) | 24 (22.9) | 24 (23.3) |
| Disease characteristics at Week 0, mean (SD) | ||||
| ASDAS | 3.7 (0.8) | 3.7 (0.7) | 3.7 (0.8) | 3.5 (0.8) |
| BASDAI | 6.7 (1.4) | 6.5 (1.4) | 6.7 (1.5) | 6.3 (1.3) |
| BASFI | 5.3 (2.1) | 5.2 (1.8) | 5.3 (2.1) | 4.8 (1.9) |
| BASMI | 3.1 (1.5) | 3.0 (1.3) | 2.8 (1.4) | 2.8 (1.6) |
| Tender joint count | 2.6 (5.0) | 1.6 (2.9) | 2.5 (4.1) | 1.9 (3.6) |
| Swollen joint count† | 0.7 (2.1) | 0.4 (1.3) | 0.8 (1.7) | 0.7 (1.6) |
| MASES | 2.5 (3.0) | 2.1 (2.8) | 2.5 (3.1) | 1.7 (2.5) |
| Imaging (MRI) | ||||
| SIJ SPARCC | 8.0 (11.4) | 8.4 (11.6) | 10.9 (12.5) | 9.4 (14.3) |
| ASspiMRI-a | 3.1 (5.2) | 3.5 (6.0) | 2.9 (5.0) | 3.2 (5.4) |
| Disease characteristics at Week 48, mean (SD) | ||||
| ASDAS | — | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| BASDAI | — | 0.4 (0.5) | 0.4 (0.5) | 0.5 (0.6) |
| BASFI | — | 0.4 (0.5) | 0.3 (0.5) | 0.5 (0.7) |
| BASMI | — | 2.1 (1.2) | 1.9 (1.2) | 2.2 (1.5) |
| Tender joint count | — | 0.2 (0.6) | 0.1 (0.5) | 0.2 (0.6) |
| Swollen joint count† | — | 0.0 (0.1) | 0.0 (0.2) | 0.0 (0.1) |
| MASES | — | 0.1 (0.5) | 0.1 (0.4) | 0.3 (1.3) |
| Imaging (MRI) | — | |||
| SIJ SPARCC | — | 1.0 (2.4) | 1.1 (2.9) | 0.7 (1.6) |
| ASspiMRI-a | — | 0.7 (1.5) | 0.7 (1.6) | 0.5 (1.3) |
*Any intake during induction period (Weeks 0 to 48) or maintenance period (Weeks 48 to 96).
†44 joints.
ASDAS, Ankylosing Spondylitis Disease Activity Score; ASspiMRI-a, Ankylosing Spondylitis spine MRI score for activity; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BMI, body mass index; CRP, C-reactive protein; CZP, certolizumab pegol; DMARD, disease-modifying anti-rheumatic drug; EAMs, extra-articular manifestations; HLA-B27, human leucocyte antigen-B27; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; mNY, modified New York; NSAID, non-steroidal anti-inflammatory drug; Q2W, every 2 weeks; Q4W, every 4 weeks; SIJ SPARCC, sacroiliac joint Spondyloarthritis Research Consortium of Canada; TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal.