Table 1

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 axSpA76 (85%)
 Non-radiographic axSpA13 (15%)
Sacroiliitis on MRI or radiographs86 (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 baseline5 (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 period3 (3%)
 NSAIDs88 (99%)
 Conventional DMARDs31 (35%)
Concomitant medication use at baseline, n (%)
 NSAIDs10 (11%)
 Conventional DMARDs0
 Systemic corticosteroids2 (2%)
Systemic corticosteroid use, n (%)†
 48-week pre-baseline period17 (19%)
 48-week treatment period6 (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.