Table 1

Baseline patient demographics and characteristics for patients participating in the safety follow-up extension study

CZP 200 mg Q2W (n=120)Placebo→CZP 200 mg Q2W (n=123)All SFE patients (N=243)
Male, n (%)64 (53.3)60 (48.8)124 (51.0)
Age, years, mean (SD)36.8 (10.0)37.3 (10.9)37.1 (10.5)
BMI, kg/m2, mean (SD)26.5 (4.9)26.5 (5.8)26.5 (5.4)
Race
 White, n (%)115 (95.8)114 (92.7)229 (94.2)
 Other, n (%)5 (4.2)9 (7.3)14 (5.8)
Symptom duration, years
 Mean (SD)7.4 (7.5)7.4 (7.2)7.4 (7.3)
 Median (min, max)4.6 (1.0, 41.9)4.8 (1.1, 38.2)4.7 (1.0, 41.9)
Time since first diagnosis, years
 Mean (SD)3.2 (4.3)3.7 (5.0)3.5 (4.7)
 Median (min, max)1.7 (0.1, 29.2)2.1 (0.2, 38.2)1.9 (0.1, 38.2)
Concomitant csDMARDs at baseline, n (%)44 (36.7)40 (32.5)84 (34.6)
CRP, mg/L
 mean (SD)16.4 (17.7)16.0 (18.1)16.2 (17.9)
 >ULN*, n (%)68 (56.7)64 (52.0)132 (54.3)
HLA-B27 positive, n (%)103 (85.8)106 (86.2)209 (86.0)
MRI/CRP status, n (%)
 MRI+/CRP+36 (30.0)30 (24.4)66 (27.2)
 MRI+/CRP−52 (43.3)59 (48.0)111 (45.7)
 MRI−/CRP+32 (26.7)34 (27.6)66 (27.2)
ASDAS, mean (SD)3.9 (0.8)3.8 (0.9)3.8 (0.8)
ASQoL†, mean (SD)0.66 (0.25)0.66 (0.25)0.66 (0.25)
BASDAI total score, mean (SD)6.9 (1.4)6.7 (1.3)6.8 (1.4)
BASFI, mean (SD)5.4 (2.2)5.2 (2.2)5.3 (2.2)
Nocturnal spinal pain, mean (SD)6.7 (2.4)6.5 (2.2)6.6 (2.3)
Total spinal pain, mean (SD)7.0 (1.9)6.8 (1.9)6.9 (1.9)
PGADA, mean (SD)6.8 (2.0)6.6 (2.1)6.7 (2.1)
SPARCC MRI SI joint inflammation score‡, mean (SD)7.6 (10.0)8.8 (12.7)8.2 (11.4)
  • Baseline patient demographics and characteristics for the SFE population are reported at Week 0 of the study, on entry into the double-blind phase.

  • *>ULN defined as values ≥10.0 mg/L.

  • †ASQoL measured on a scale of 0–1.

  • ‡Numbers of patients with SPARCC MRI SI joint inflammation scores were lower than the total population in each randomisation group (CZP: n=89; placebo→CZP: n=91; all SFE: n=180).

  • ASDAS, Ankylosing Spondylitis Disease Activity Score; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BMI, body mass index; CRP, C-reactive protein; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; HLA-B27, human leukocyte antigen B27; PGADA, Patients Global Assessment of Disease Activity; Q2W, every 2 weeks; SFE, safety follow-up extension; SI, sacroiliac; SPARCC, SpondyloArthritis Research Consortium of Canada; ULN, upper limit of normal.