Table 1

Demographics and baseline disease characteristics

Characteristics mean (SD) unless specifiedSecukinumab
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 (%)
 Current47 (28.1)39 (23.6)39 (23.5)
 Former20 (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 insidious150 (89.8)147 (89.1)152 (91.6)
 Back pain improving with exercise148 (88.6)139 (84.2)146 (88.0)
 Back pain worsening with rest152 (91.0)151 (91.5)157 (94.6)
 Night pain with improvement on getting up147 (88.0)147 (89.1)143 (86.1)
 Awakening due to back pain in second half of night143 (85.6)145 (87.9)137 (82.5)
 Alternating buttock pain102 (61.1)98 (59.4)101 (60.8)
Efficacy variables at baseline
 PtGA of disease activity71.7 (14.4)74.5 (14.2)72.4 (15.6)
 PGA of disease activity62.6 (15.7)62.2 (19.5)64.0 (17.6)
 BASDAI score7.3 (1.2)7.2 (1.4)7.3 (1.2)
 TJC15.3 (15.3)14.9 (14.5)15.6 (15.0)
 SJC6.1 (8.7)5.9 (7.7)6.2 (9.0)
 SPARCC score4.5 (4.2)4.7 (4.3)4.7 (4.4)
 HAQ-DI score1.4 (0.5)1.4 (0.6)1.5 (0.5)
 FACIT-Fatigue22.0 (9.4)21.6 (10.1)21.0 (9.5)
 BASFI, score6.3 (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 (%)
 Positive32 (35.2)25 (28.4)28 (34.1)
 Negative59 (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.