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Table 1 Baseline characteristics of patients enrolled in COAST-X

From: Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

  PBO
(N = 105)
IXE Q4W
(N = 96)
IXE Q2W
(N = 102)
Total
(N = 303)
Age, years 39.9 (12.4) 40.9 (14.5) 40.0 (12.0) 40.3 (12.9)
Male, n (%) 44 (41.9) 50 (52.1) 49 (48.0) 143 (47.2)
Weight, kg 75.8 (18.4) 79.5 (16.5) 77.3 (16.6) 77.5 (17.2)
Duration of nr-axSpA symptoms, years 10.1 (8.3) 11.3 (10.7) 10.6 (10.1) 10.7 (9.7)
Time since nr-axSpA diagnosis, years 3.1 (4.5) 4.2 (5.5) 3.4 (4.6) 3.6 (4.9)
CRP, mg/L 14.3 (24.4) 12.4 (18.0) 12.1 (17.8) 12.9 (20.4)
Screening MRI/CRP status, n (%)
 Positive MRI and elevated CRP 38 (36.2) 30 (31.3) 39 (38.2) 107 (35.3)
 Positive MRI and nonelevated CRP 40 (38.1) 36 (37.5) 34 (33.3) 110 (36.3)
 Negative MRI and elevated CRP 26 (24.8) 30 (31.3) 28 (27.5) 84 (27.7)
Therapy, n (%)
 Current csDMARD use, including MTX 36 (34.3) 40 (41.7) 42 (41.2) 118 (38.9)
 Current MTX use 17 (16.2) 17 (17.7) 15 (14.7) 49 (16.2)
 Current NSAID/COX-2 inhibitor use 96 (91.4) 81 (84.4) 95 (93.1) 272 (89.8)
ASDAS-CRP 3.8 (0.9) 3.8 (0.8) 3.9 (0.8) 3.8 (0.8)
BASDAI 7.2 (1.5) 7.0 (1.5) 7.3 (1.3) 7.2 (1.4)
Sleep (JSEQ) 9.4 (5.6) 9.4 (5.3) 10.4 (5.3) 9.7 (5.4)
Reported part- or full-time work, n (%) 69 (65.7) 61 (63.5) 66 (64.7) 196 (64.7)
Work productivity (WPAI-SpA)
 Absenteeism 15.6 (26.8)a 12.1 (27.0)b 16.1 (26.5)c 14.7 (26.7)d
 Presenteeism* 62.1 (18.7)e 50.2 (22.3)f 56.3 (24.8)g 56.7 (22.4)h
 Overall work impairment* 65.6 (20.2)e 51.9 (22.8)f 59.3 (26.4)g 59.5 (23.7)h
 Activity impairment 66.4 (20.4) 63.3 (21.5) 66.1 (20.7) 65.3 (20.8)
  1. aN = 65; bN = 53; cN = 60; dN = 178; eN = 62; fN = 49; gN = 57; hN = 168
  2. Data are mean (SD) unless otherwise stated
  3. P values from Fisher’s exact test for categorical data (Monte Carlo estimate of exact p-value was used for categorical values that have more than 2 categories) and analysis of variance with treatment as a factor for continuous data. *p < 0.05
  4. ASDAS-CRP Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein; BASDAI Bath Ankylosing Spondylitis Disease Activity Index; csDMARD Conventional synthetic disease-modifying antirheumatic drug; COX-2 Cyclooxygenase-2; CRP C-reactive protein; IXE Q2W 80-mg ixekizumab every 2 weeks; IXE Q4W 80-mg ixekizumab every 4 weeks; JSEQ Jenkins Sleep Evaluation Questionnaire; MRI Magnetic resonance imaging; MTX Methotrexate; n number of patients in a subcategory; N Number of patients in the analysis category; NRS Numeric rating score; nr-axSpA nonradiographic axial spondyloarthritis; PBO Placebo; PtGA Patient’s Global Assessment of Disease Activity; SD Standard deviation; WPAI-SpA Work Productivity and Activity Impairment Questionnaire for Ankylosing Spondylitis