Table 1

Demographics and disease characteristics for patients enrolled in C-OPTIMISE

Induction periodPatients 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)
 Range18–4518–4518–4518–45
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 (%)
 Caucasian681 (92.5)97 (93.3)97 (92.4)98 (94.2)
 Asian38 (5.2)5 (4.8)6 (5.7)5 (4.8)
 Other/mixed/missing17 (2.3)2 (1.9)2 (1.9)1 (1.0)
Geographical region, n (%)
 North America33 (4.5)3 (2.9)3 (2.9)4 (3.8)
 Western Europe91 (12.4)10 (9.6)9 (8.6)8 (7.7)
 Eastern Europe537 (73.0)82 (78.8)83 (79.0)82 (78.8)
 Asia75 (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)
 Median3.53.93.53.3
Time since diagnosis, years
 Mean (SD)2.2 (1.7)2.5 (1.7)2.0 (1.7)2.1 (1.7)
 Median1.62.71.31.3
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 (%)
 Uveitis111 (15.1)16 (15.4)20 (19.0)17 (16.3)
 Inflammatory bowel disease17 (2.3)2 (1.9)3 (2.9)1 (1.0)
 Psoriasis45 (6.1)8 (7.7)2 (1.9)7 (6.7)
Concomitant medication,* n (%)
 NSAIDs618 (84.0)85 (81.7)92 (87.6)85 (82.5)
 DMARDs166 (22.6)21 (20.2)24 (22.9)24 (23.3)
Disease characteristics at Week 0, mean (SD)
ASDAS3.7 (0.8)3.7 (0.7)3.7 (0.8)3.5 (0.8)
BASDAI6.7 (1.4)6.5 (1.4)6.7 (1.5)6.3 (1.3)
BASFI5.3 (2.1)5.2 (1.8)5.3 (2.1)4.8 (1.9)
BASMI3.1 (1.5)3.0 (1.3)2.8 (1.4)2.8 (1.6)
Tender joint count2.6 (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)
MASES2.5 (3.0)2.1 (2.8)2.5 (3.1)1.7 (2.5)
Imaging (MRI)
 SIJ SPARCC8.0 (11.4)8.4 (11.6)10.9 (12.5)9.4 (14.3)
 ASspiMRI-a3.1 (5.2)3.5 (6.0)2.9 (5.0)3.2 (5.4)
Disease characteristics at Week 48, mean (SD)
ASDAS0.8 (0.2)0.8 (0.2)0.8 (0.2)
BASDAI0.4 (0.5)0.4 (0.5)0.5 (0.6)
BASFI0.4 (0.5)0.3 (0.5)0.5 (0.7)
BASMI2.1 (1.2)1.9 (1.2)2.2 (1.5)
Tender joint count0.2 (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)
MASES0.1 (0.5)0.1 (0.4)0.3 (1.3)
Imaging (MRI)
 SIJ SPARCC1.0 (2.4)1.1 (2.9)0.7 (1.6)
 ASspiMRI-a0.7 (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.