Skip to main content

Table 1 Baseline demographic and clinical characteristics of the intention-to-treat population

From: Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial

Variable

Placebo + MTX (n = 398)

Sarilumab 150 mg q2w + MTX (n = 400)

Sarilumab 200 mg q2w + MTX (n = 399)

Age (years)

50.9 ± 11.2

50.1 ± 11.9

50.8 ± 11.8

Female (%)

80.7

79.8

84.5

Race (%)

   

Caucasian

86.2

86.3

86.0

Black

2.5

2.5

2.0

Asian

8.0

8.3

8.3

Other

3.3

3.0

3.8

Region (%)

   

Western Europe

18.6

18.8

18.8

South America

38.9

38.8

38.8

Rest of world

42.5

42.5

42.4

RA duration (years)

9.1 ± 8.1

9.5 ± 8.5

8.6 ± 7.0

Prior biologic DMARD use (%)

20.6

20.5

19.5

Seropositive for rheumatoid factor (%)

84.4

87.1

82.6

Anti-CCP antibody positive (%)

85.4

90.2

84.9

Tender joint count

26.8 ± 13.8

27.2 ± 14.2

26.5 ± 14.5

Swollen joint count

16.7 ± 9.3

16.6 ± 9.0

16.8 ± 9.7

CRP (mg/dl)

2.0 ± 2.3

2.4 ± 2.3

2.2 ± 2.4

DAS28-CRP

5.9 ± 0.9

6.0 ± 0.9

6.0 ± 0.9

PtGA (VAS)

63.7 ± 19.9

64.4 ± 20.4

66.3 ± 20.8

Pain VAS

63.7 ± 19.9

65.4 ± 21.4

66.7 ± 21.4

HAQ-DI

1.6 ± 0.7

1.6 ± 0.6

1.7 ± 0.6

FACIT-F

27.2 ± 10.4

26.3 ± 9.8

25.9 ± 10.4

SF-36 PCS

31.9 ± 6.9

31.5 ± 6.7

31.1 ± 6.8

SF-36 MCS

38.9 ± 11.4

39.0 ± 11.3

38.7 ± 12.0

  1. Numbers are presented as mean ± SD unless mentioned otherwise. q2w every 2 weeks, MTX methotrexate, Anti-CCP anti-cyclic citrullinated peptide, CRP C-reactive protein, DAS28-CRP 28-joint disease activity score using C-reactive protein, DMARD disease-modifying anti-rheumatic drug, FACIT-F functional assessment of chronic illness therapy-fatigue scale, HAQ-DI health assessment questionnaire disability index, SF-36 36-item Short Form Health Survey-Version 2, MCS mental component summary, PCS physical component summary, PtGA patient global assessment of disease activity, RA rheumatoid arthritis, VAS visual analog scale