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Table 2 Between-group differences in primary and secondary continuous outcomes at baseline and at the end of the RCT phase

From: A randomized, double-blind, placebo-controlled 12-week trial of infliximab in patients with juvenile-onset spondyloarthritis

 

Placebo

Infliximab

 
 

Baseline

Week 12

Baseline

Week 12

p*

Active joints, no.

6.1 (3.7)

4.1 (3.0)

4.5 (1.7)

1.4 (2.4)

0.0002

Tender joints, no.

10.6 (6.8)

7.8 (7.9)

6.7 (3.1)

1.0 (2.0)

0.0001

Swollen joints, no.

6.5 (3.6)

4.5 (3.0)

5.0 (2.0)

1.5 (2.4)

0.0003

Tender entheses, no.

9.2 (4.8)

7.1 (5.9)

9.5 (9.7)

1.4 (2.3)

0.004

CHAQ score, 0–3

2.0 (0.5)

2.0 (0.4)

1.9 (0.5)

1.6 (0.8)

0.1

BASDAI score, 0–10

6.1 (1.9)

5.5 (1.8)

5.5 (2.5)

3.4 (2.3)

0.07

BASFI score, 0–10

5.4 (2.6)

4.9 (2.0)

5.5 (2.8)

3.0 (2.8)

0.12

hsCRP level, mg/dl

30.1 (23.4)

19.7 (17.3)

23.1 (9.5)

3.1 (5.0)

0.003

Modified Schober’s, cm

4.5 (1.1)

4.6 (1.3)

4.5 (1.5)

4.7 (1.0)

0.84

Lateral flexion, cm

17.6 (7.0)

16.7 (5.4)

25.4 (14.6)

18.1 (7.1)

0.81

Chest expansion, cm

4.5 (1.5)

4.8 (1.4)

4.4 (1.3)

4.7 (1.5)

0.94

Hip rotation, cm

39.9 (8.9)

42.3 (11.8)

50 (16.1)

47.4 (9.9)

0.92

Physician assessment of disease activity, 10-cm NRS

6.7 (1.6)

5.1 (2.8)

6.4 (1.0)

1.3 (2.1)

0.0006

Physician assessment of health status, 10-cm NRS

3.7 (2.1)

5.0 (2.7)

4.1 (1.3)

7.6 (2.0)

0.01

Parent/patient assessment of well-being, 10-cm NRS

6.4 (1.3)

5.3 (2.6)

3.8 (1.9)

2.3 (2.2)

0.39

Pain score, 0–10 NRS

7.5 (1.8)

5.8 (2.7)

7.2 (1.9)

2.4 (1.9)

0.003

  1. Values represent the mean (SD)
  2. BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, CHAQ Childhood Health Assessment Questionnaire, hsCRP high-sensitive C-reactive protein
  3. *p-values reflect the comparison of the outcomes at week 12 and obtained with ANCOVA analysis adjusting for baseline values