Table 1.
Baseline demographics and patient characteristics for all patients included in the imaging set
| r-axSpA |
nr-axSpA |
|||||
|---|---|---|---|---|---|---|
| Overall r-axSpA (n=95) |
Week 0 CZP (dose combined) (n=63) | Placebo (n=32) | Overall nr-axSpA (n=68) |
Week 0 CZP (dose combined) (n=46) | Placebo (n=22) | |
| Except where indicated otherwise, values are n (%) at baseline | ||||||
| Age, years, mean (SD) | 40.6 (11.6) | 40.5 (10.3) | 40.8 (13.8) | 36.6 (12.9) | 36.7 (12.8) | 36.2 (13.5) |
| Gender, male | 69 (72.6) | 44 (69.8) | 25 (78.1) | 36 (52.9) | 24 (52.2) | 12 (54.5) |
| BMI, mean (SD) | 27.2 (5.3) | 27.3 (5.5) | 26.9 (5.0) | 26.4 (5.8) | 26.9 (5.8) | 25.5 (5.9) |
| Symptom duration, years, median (minimum, maximum) | 9.5 (0.3, 50.9) | 8.9 (0.3, 44.8) | 9.8 (0.5, 50.9) | 5.2 (0.3, 39.6) | 5.4 (0.3, 31.4) | 5.0 (0.5, 39.6) |
| Symptom duration, <5 years | 33 (34.7) | 23 (36.5) | 10 (31.3) | 34 (50.0) | 23 (50.0) | 11 (50.0) |
| Smoking status | ||||||
| Current | 21 (22.1) | 15 (23.8) | 6 (18.8) | 20 (29.4) | 13 (28.3) | 7 (31.8) |
| Former | 18 (18.9) | 8 (12.7) | 10 (31.3) | 13 (19.1) | 9 (19.6) | 4 (18.2) |
| Never | 56 (58.9) | 40 (63.5) | 16 (50.0) | 35 (51.5) | 24 (52.2) | 11 (50.0) |
| Positive for HLA-B27 | 78 (82.1) | 51 (81.0) | 27 (84.4) | 53 (77.9) | 34 (73.9) | 19 (86.4) |
| CRP mg/L, median | 14.2 | 14.0 | 16.0 | 10.5 | 10.5 | 10.5 |
| SPARCC SI joint score, mean (SD) | 7.2 (11.9) | 7.2 (11.9) | 12.6 (17.1) | 7.2 (9.8) | 7.2 (9.8) | 11.8 (13.5) |
| SI joint inflammation on MRI (SPARCC≥2) | 49 (52.7) | 33 (54.1) | 16 (50.0) | 41 (68.3) | 26 (65.0) | 15 (75.0) |
| Berlin, mean (SD) | 5.3 (5.9) | 5.3 (5.9) | 5.5 (7.0) | 2.8 (4.2) | 2.8 (4.2) | 3.2 (7.7) |
| Spinal inflammation on MRI (Berlin >2) | 54 (58.1) | 36 (59.0) | 18 (56.3) | 19 (31.7) | 14 (35.0) | 5 (25.0) |
| SI joint and spinal inflammation on MRI (SPARCC≥2 and Berlin >2) | 32 (34.4) | 23 (37.7) | 9 (28.1) | 11 (19.0) | 8 (21.1) | 3 (15.0) |
| BASDAI, mean (SD) | 6.6 (1.5) | 6.5 (1.5) | 6.8 (1.7) | 6.5 (1.5) | 6.5 (1.5) | 6.4 (1.4) |
| BASFI, mean (SD) | 6.0 (2.1) | 5.9 (2.1) | 6.3 (1.9) | 4.8 (2.2) | 4.8 (2.3) | 4.7 (2.0) |
| BASMI, mean (SD) | 4.4 (1.5) | 4.2 (1.5) | 4.8 (1.5) | 2.9 (1.4) | 3.0 (1.4) | 2.8 (1.3) |
| ASDAS, mean (SD) | 4.0 (0.9) | 3.9 (0.8) | 4.2 (1.0) | 3.7 (0.9) | 3.7 (0.8) | 3.8 (1.0) |
| Peripheral arthritis* | 36 (37.9) | 20 (31.7) | 16 (50.0) | 29 (42.6) | 16 (34.8) | 13 (59.1) |
| Enthesitis† | 72 (75.8) | 46 (73.0) | 26 (81.3) | 50 (73.5) | 33 (71.7) | 17 (77.3) |
| Extraspinal features of axSpA (either patient history or current diagnosis) Defined by the ASAS classification criteria screening assessment | ||||||
| Heel enthesitis | 38 (40.0) | 24 (38.1) | 14 (43.8) | 25 (36.8) | 14 (30.4) | 11 (50.0) |
| Uveitis | 22 (23.2) | 12 (19.0) | 10 (31.3) | 14 (20.6) | 9 (19.6) | 5 (22.7) |
| Psoriasis | 3 (3.2) | 2 (3.2) | 1 (3.1) | 5 (7.4) | 4 (8.7) | 1 (4.5) |
| Inflammatory bowel disease | 6 (6.3) | 3 (4.8) | 3 (9.4) | 1 (1.5) | 0 | 1 (4.5) |
*Defined as ≥1 swollen joint in a 44-joint assessment.
†Defined as a Maastricht Ankylosing Spondylitis Entheses Score (MASES) score >0.
ASDAS, Ankylosing Spondylitis Disease Activity Score; 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; HLA, human leucocyte antigen; nr-axSpA, non-radiographic axial spondyloarthritis; r-axSpA, radiographic axial spondyloarthritis; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada.