Table 1

Baseline characteristics of all CZP patients

Overall axSpA
N=315
AS
n=174
nr-axSpA
n=141
Mean age, years (SD)39.7 (12.0)41.5 (11.7)37.5 (11.9)
Male, %62.273.048.9
Symptom duration, years, median (min, max)7.8 (0.3, 50.9)9.1 (0.3, 50.9)5.8 (0.3, 41.5)
CRP, mg/L, median (min, max)13.4 (0.1, 174.8)14.2 (0.1, 174.8)12.0 (0.1, 156.2)
Patients with elevated CRP (>15 mg/L), %40.643.736.9
BASDAI, mean (SD)6.4 (1.5)6.4 (1.6)6.5 (1.5)
BASFI, mean (SD)5.4 (2.3)
n=314
5.7 (2.2)4.9 (2.3)
n=140
BASMI linear, mean (SD)3.8 (1.7)4.4 (1.7)3.1 (1.5)
ASDAS, mean (SD)3.9 (0.9)
n=313
3.9 (0.9)3.8 (0.8)
n=139
Spinal radiographs
 mSASSS
   Mean (SD)*9.5 (16.1)13.2 (18.2)4.4 (11.0)
   Median1.5
n=190
3.0
n=110
0.0
n=80
 Patients with ≥1 bridging or non-bridging syndesmophyte at baseline, n (%)63 (33.2)47 (42.7)16 (20.0)
MRI setn=158n=92n=66
 SPARCC (SI joints)
   Mean (95% CI)*8.1 (6.1, 10.2)8.5 (5.6, 11.4)7.5 (4.4, 10.6)
   Median2.0
n=151
1.0
n=91
3.0
n=60
 Patients with MRI inflammation (SPARCC ≥2), estimate, %51.247.057.3
 Berlin score (spine)
   Mean (95% CI)*6.2 (4.8, 7.5), n=1577.4 (5.6, 9.2)4.4 (2.4, 6.5), n=65
   Median2.0
n=153
4.30.5
n=61
 Patients with MRI inflammation (Berlin >2) estimate, %50.4
n=157
57.640.1
n=65
  • *Least squares mean scores were estimated using mixed-model for repeated measures analyses. Inflammation was defined as Berlin >2 or SPARCC ≥2. Data are presented for all patients who received ≥1 dose CZP at any point in the trial. To define AS and nr-axSpA subpopulations, the most recent SI joint X-rays (performed ≤12 months prior to screening) were locally read to determine the presence/absence of radiographic sacroiliitis.

  • AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; CZP, certolizumab pegol; mSASSS, modified Stoke Ankylosing Spondylitis Spine Score; nr, non-radiographic; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada.