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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