Table 1.
PBO (N = 105) | IXE Q4W (N = 96) | IXE Q2W (N = 102) | |
---|---|---|---|
Age, years | 39.9 (12.4) | 40.9 (14.5) | 40.0 (12.0) |
Male, n (%) | 44 (41.9) | 50 (52.1) | 49 (48.0) |
Weight, kg | 75.8 (18.4)a | 79.5 (16.5) | 77.3 (16.6) |
Duration of nr-axSpA symptoms, years | 10.1 (8.3) | 11.3 (10.7) | 10.6 (10.1) |
Time since nr-axSpA diagnosis, years | 3.1 (4.5) | 4.2 (5.5) | 3.4 (4.6) |
CRP, mg/l | 14.3 (24.4) | 12.4 (18.0) | 12.1 (17.8) |
Screening MRI/CRP status, n (%) | |||
Positive MRI and elevated CRP | 38 (36.2) | 30 (31.3) | 39 (38.2) |
Positive MRI and non-elevated CRP | 40 (38.1) | 36 (37.5) | 34 (33.3) |
Negative MRI and elevated CRP | 26 (24.8) | 30 (31.3) | 28 (27.5) |
Therapy, n (%) | |||
Current cDMARD use, including MTX | 36 (34.3) | 40 (41.7) | 42 (41.2) |
Current MTX use | 17 (16.2) | 17 (17.7) | 15 (14.7) |
ASDAS | 3.8 (0.9) | 3.8 (0.8) | 3.9 (0.8) |
Patient global disease activity | 7.4 (1.7) | 7.1 (1.7) | 7.6 (1.5) |
Spinal pain NRS | 7.4 (1.6) | 7.3 (1.7) | 7.4 (1.6) |
Function, BASFI | 6.7 (2.0) | 6.4 (2.1) | 6.5 (1.8) |
Stiffness, BASDAI questions 5 and 6 | 7.0 (1.9) | 6.8 (2.0) | 7.1 (1.5) |
Fatigue NRS | 7.1 (1.8) | 7.2 (1.6) | 7.2 (1.8) |
BASDAI fatigue | 7.4 (1.6) | 7.4 (1.6) | 7.5 (1.6) |
Spinal pain at night NRS | 7.3 (1.7) | 7.0 (1.9) | 7.5 (1.8) |
aNx = 104
Data are mean (SD) unless otherwise stated. Percentage was calculated by n/N*100%
ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, cDMARD conventional disease-modifying anti-rheumatic drug, CRP C-reactive protein, MRI magnetic resonance imaging, IXE Q2W 80-mg ixekizumab every 2 weeks, IXE Q4W 80-mg ixekizumab every 4 weeks, MTX methotrexate, N number of patients in the analysis category, n number of patients in subgroup, NRS numeric rating scale, nr-axSpA non-radiographic axial spondyloarthritis, PBO placebo, SD standard deviation