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Table 2 Patient baseline clinical characteristics

From: Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial

 

Placebo (N = 27)

Namilumab

20 mg (N = 28)

80 mg (N = 25)

150 mg (N = 28)

Mean duration of RA at screening, years

10.04 ± 8.880

9.02 ± 7.476

8.62 ± 8.501

7.35 ± 4.976

Positive rheumatoid factor at baseline

16 (59.3)

16 (57.1)

12 (48.0)

18 (64.3)

Anti-citrullinated peptide antibodies at baseline

20 (74.1)

19 (67.9)

12 (48)

21 (75)

Mean MTX dose at baseline, mg/week

15.73 ± 4.04

16.54 ± 4.741

16.06 ± 4.370

15.96 ± 4.238

Type of failure of prior treatment

 MTX-IR

23 (85.2)

23 (82.1)

22 (88.0)

24 (85.7)

 TNF-IR

4 (14.8)

5 (17.9)

3 (12.0)

4 (14.3)

Corticosteroid use at baseline: yes

6 (22.2)

14 (50.0)

7 (28.0)

9 (32.1)

Mean DAS28-CRP score

5.71 ± 1.021

5.62 ± 0.931

5.63 ± 0.774

5.71 ± 1.122

 Mean DAS28-ESR score

7.19 ± 1.033

7.07 (0.876)

6.99 (0.741)

7.2 (1.023)

 Mean 66 swollen joint count

12.4 ± 8.78

12.8 (9.13)

15.8 (10.92)

13.6 (7.00)

 Mean 68 tender joint count

23.0 ± 13.12

24.1 (11.91)

25.4 (12.49)

24.2 (13.24)

Mean patient’s global assessment of disease activity

68.6 ± 17.6

68.8 ± 15.17

65.9 ± 15.69

66.8 ± 16.27

Mean patient assessment of pain (VAS), mm

77.3 ± 17.43

75.0 ± 17.73

72.6 ± 13.7

69.3 ± 19.69

Mean physician’s global assessment of disease activity (mm)

68.6 ± 17.22

68.8 ± 15.17

65.9 ± 15.69

66.8 ± 16.27

 Mean HAQ-DI

1.84 ± 0.67

1.61 ± 0.509

1.52 ± 0.516

1.49 ± 0.605

 Median CRP, mg/L

7.91

3.95

6.29

9.41

 Mean CRP, mg/L

17.12 ± 22.63

12.24 ± 15.4

8.92 ± 8.9

24.55 ± 60.5

 Mean MBDA score

48.15 ± 17.515

47.92 ± 20.17

41.91 ± 15.47

48.77 ± 17.75

 Mean C1M, ng/mL

35.45 ± 19.355

35.65 ± 24.99

35.36 ± 26.26

46.68 ± 45.56

SF-36 mental health

49.1± 17.92

50.4 ± 17.19

57.2 ± 18.08

50.6 ±18.24

SF-36 vitality

30.1 ± 17.51

31.5 ± 14.6

36.1 ± 14.35

31.7 ± 16.67

  1. Values are mean ± SD or n (%) unless otherwise indicated. CRP C-reactive protein, DAS28 Disease Activity Score 28, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire Disability Index, MBDA multibiomarker disease activity, MTX methotrexate therapy, MTX-IR inadequate response to methotrexate therapy, RA rheumatoid arthritis, TNF-IR inadequate response or intolerance to an anti-tumour necrosis factor biologic therapy, VAS visual analogue scale, SF-36 36-Item Short-Form Health Survey