Baseline and disease characteristics for the Safety Set (N=89)
| CZP 200 mg Q2 W (N=89) | |
|---|---|
| Age (years), mean (SD) | 46.5 (11.2) |
| Male, n (%) | 56 (63%) |
| BMI (kg/m2), mean (SD) | 27.3 (5.1) |
| Racial group: Caucasian, n (%) | 87 (98%) |
| Diagnosis, n (%) | |
| Radiographic axSpA | 76 (85%) |
| Non-radiographic axSpA | 13 (15%) |
| Sacroiliitis on MRI or radiographs | 86 (97%) |
| Time since axSpA diagnosis (years), mean (SD) | 8.6 (8.4) |
| HLA-B27 positive, n (%) | 89 (100%) |
| Uveitis history, n (%) | 89 (100%) |
| Time since onset of first uveitis flare (years), mean (SD) | 9.9 (9.0) |
| Number of uveitis flares in 48 weeks pre-baseline, mean (SD) | 1.3 (0.7) |
| Number of patients with active flare at baseline | 5 (6%) |
| Psoriasis history, n (%) | 3 (3%) |
| Inflammatory bowel disease history, n (%) | 0 |
| Prior medication exposure, n (%) | |
| TNFi* | 4 (4%) |
| TNFi use in the 48-week pre-baseline period | 3 (3%) |
| NSAIDs | 88 (99%) |
| Conventional DMARDs | 31 (35%) |
| Concomitant medication use at baseline, n (%) | |
| TNFi | 0 |
| NSAIDs | 10 (11%) |
| Conventional DMARDs | 0 |
| Systemic corticosteroids | 2 (2%) |
| Systemic corticosteroid use, n (%)† | |
| 48-week pre-baseline period | 17 (19%) |
| 48-week treatment period | 6 (7%) |
| Tender joint count ≥1, n (%) | 59 (66%) |
| Swollen joint count ≥1, n (%) | 33 (37%) |
| CRP, mg/L, mean (SD) | 14.8 (26.8) |
| CRP > ULN, n (%) | 30 (34%) |
Patients were enrolled from the Czech Republic (n=35), Germany (n=6), the Netherlands (n=6), Poland (n=38), and Spain (n=4).
*Etanercept in all four patients.
†In total, 20 patients had exposure to systemic corticosteroids during the 48-week pre- and post-baseline periods. Some patients used systemic corticosteroids in both the pretreatment and treatment periods.
ASAS, Assessment of SpondyloArthritis international Society; axSpA, axial spondyloarthritis; BMI, body mass index; CRP, C-reactive protein; CZP, certolizumab pegol; DMARD, disease-modifying antirheumatic drug; NSAIDs, non-steroidal anti-inflammatory drugs; Q2W, every 2 weeks; TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal.