Table 1.
Demographics and baseline disease characteristics
| Characteristics mean (SD) unless specified | Secukinumab 300 mg s.c. (N=167) |
Secukinumab 150 mg s.c. (N=165) |
Placebo (N=166) |
| Age (years) | 46.2 (12.3) | 46.9 (11.5) | 46.6 (11.5) |
| Male, n (%) | 77 (46.1) | 81 (49.1) | 88 (53.0) |
| Body mass index (kg/m2) | 27.3 (4.8) | 29.0 (6.4) | 28.3 (5.5) |
| Smoking status (tobacco), n (%) | |||
| Current | 47 (28.1) | 39 (23.6) | 39 (23.5) |
| Former | 20 (12.0) | 34 (20.6) | 25 (15.1) |
| Total spinal pain score, VAS | 72.5 (13.8) | 73.6 (15.4) | 74.0 (13.7) |
| Inflammatory back pain parameters, n (%) | |||
| Onset of back pain is insidious | 150 (89.8) | 147 (89.1) | 152 (91.6) |
| Back pain improving with exercise | 148 (88.6) | 139 (84.2) | 146 (88.0) |
| Back pain worsening with rest | 152 (91.0) | 151 (91.5) | 157 (94.6) |
| Night pain with improvement on getting up | 147 (88.0) | 147 (89.1) | 143 (86.1) |
| Awakening due to back pain in second half of night | 143 (85.6) | 145 (87.9) | 137 (82.5) |
| Alternating buttock pain | 102 (61.1) | 98 (59.4) | 101 (60.8) |
| Efficacy variables at baseline | |||
| PtGA of disease activity | 71.7 (14.4) | 74.5 (14.2) | 72.4 (15.6) |
| PGA of disease activity | 62.6 (15.7) | 62.2 (19.5) | 64.0 (17.6) |
| BASDAI score | 7.3 (1.2) | 7.2 (1.4) | 7.3 (1.2) |
| TJC | 15.3 (15.3) | 14.9 (14.5) | 15.6 (15.0) |
| SJC | 6.1 (8.7) | 5.9 (7.7) | 6.2 (9.0) |
| SPARCC score | 4.5 (4.2) | 4.7 (4.3) | 4.7 (4.4) |
| HAQ-DI score | 1.4 (0.5) | 1.4 (0.6) | 1.5 (0.5) |
| FACIT-Fatigue | 22.0 (9.4) | 21.6 (10.1) | 21.0 (9.5) |
| BASFI, score | 6.3 (1.8) | 6.5 (1.9) | 6.4 (2.0) |
| Evidence of current PsO, n (%) | 152 (91.0) | 147 (89.1) | 153 (92.2) |
| hsCRP (mg/L) | 11.7 (23.3) | 11.5 (21.2) | 8.7 (15.4) |
| Axial PsA history | |||
| Presence of peripheral arthritis, n (%) | 133 (79.6) | 136 (82.4) | 137 (82.5) |
| Time since first signs and symptoms of arthritis (years) | 7.0 (7.1) | 7.8 (8.4) | 7.9 (8.4) |
| Time since first diagnosis of peripheral arthritis (years) | 5.3 (6.6) | 4.7 (5.1) | 5.1 (7.0) |
| Time since first axial signs and symptoms (years) | 6.9 (7.7) | 7.9 (7.9) | 7.7 (9.5) |
| Time since diagnosis of axial PsA prior to baseline (years) | 2.8 (4.4) | 3.3 (4.7) | 2.9 (5.0) |
| Patient with diagnosis of AS, n (%) | 35 (21.0) | 36 (21.8) | 42 (25.3) |
| MRI parameters at baseline* | |||
| Berlin MRI score for the entire spine, Mean (SD) | n=150 2.0 (3.95) |
n=144 1.0 (1.68) |
n=148 1.5 (2.45) |
| Berlin MRI score for SIJ, Mean (SD) |
n=151 1.7 (2.94) |
n=142 1.6 (2.77) |
n=146 1.8 (3.32) |
| HLA-B27 status, n (%)† | |||
| Positive | 32 (35.2) | 25 (28.4) | 28 (34.1) |
| Negative | 59 (64.8) | 63 (71.6) | 54 (65.9) |
*n represents number of patients with evaluable MRI data at baseline and post-baseline.
†Based on available HLA-B27 status data (secukinumab 300 mg (n=91), 150 mg (n=88) and placebo (n=82)).
AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy Fatigue Scale; HAQ-DI, Health Assessment Questionnaire Disability Index; HLA, human leukocyte antigen; hsCRP, high sensitivity C-reactive protein; MTX, methotrexate; N, total number of randomised patients; PGA, physician global assessment; PsA, psoriatic arthritis; PsO, psoriasis; PtGA, patients global assessment; s.c., subcutaneous; SIJ, sacroiliac joints; SJC, swollen joint count; SPARCC, Spondyloarthritis Research Consortium of Canada enthesitis index; TJC, tender joint count; VAS, Visual Analogue Scale.