Skip to main content

Table 1 Baseline patient demographic and disease characteristics at week 0 and week 52 (full-analysis set)

From: Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Demographic variable

Maintenance group (n = 69)

Switch group (n = 78)

Overall (n = 147)

Age, years

52.6 ± 11.0

54.5 ± 11.0

53.6 ± 11.0

Female, n (%)

52 (75.4)

69 (88.5)

121 (82.3)

Weight, kg

59.9 ± 11.6

57.2 ± 9.6

58.5 ± 10.7

Functional status in RA, n (%)

 I

11 (15.9)

15 (19.2)

26 (17.7)

 II

50 (72.5)

45 (57.7)

95 (64.6)

 III

8 (11.6)

18 (23.1)

26 (17.7)

 IV

0

0

0

Time since RA diagnosis, years

8.1 ± 8.4

7.9 ± 7.8

8.0 ± 8.1

Previous use of biologics, n (%)

 Week 0†

11 (15.9)

8 (10.3)

19 (12.9)

MTX dose, mg/week

 Week 52

12.6 ± 2.7

12.6 ± 2.7

12.6 ± 2.7

Baseline corticosteroids, n (%)

 Week 0†

57 (82.6)

70 (89.7)

127 (86.4)

Positive rheumatoid factor test result, n (%)

 Week 0†

48 (69.6)

52 (66.7)

100 (68.0)

Tender joint count from 68 joints

 Week 0†

18.4 ± 9.83

18.9 ± 10.68

18.7 ± 10.26

 Week 52

1.9 ± 2.48

2.2 ± 2.60

2.0 ± 2.54

Tender joint count from 28 joints

 Week 0†

11.5 ± 5.90

11.5 ± 5.76

11.5 ± 5.81

 Week 52

1.3 ± 1.83

1.4 ± 1.91

1.3 ± 1.87

Swollen joint count from 66 joints

 Week 0†

13.2 ± 8.09

13.5 ± 7.94

13.4 ± 7.98

 Week 52

1.0 ± 1.58

1.3 ± 2.04

1.2 ± 1.84

Swollen joint count from 28 joints

 Week 0†

9.1 ± 5.42

9.1 ± 5.45

9.1 ± 5.42

 Week 52

0.7 ± 1.21

0.9 ± 1.46

0.8 ± 1.34

DAS28-ESR

 Week 0†

6.300 ± 0.8949

6.343 ± 0.9170

6.323 ± 0.9039

 Week 52

3.068 ± 1.0238

3.161 ± 0.9745

3.117 ± 0.9956

ESR, mm/hour

 Week 0†

51.3 ± 21.75

58.4 ± 26.73

55.1 ± 24.69

 Week 52

25.4 ± 15.66

29.3 ± 20.88

27.5 ± 18.65

CRP, mg/dL

 Week 0†

1.22 ± 1.341

1.52 ± 2.152

1.38 ± 1.818

 Week 52

0.20 ± 0.364

0.34 ± 0.770

0.28 ± 0.616

HAQ-DI

 Week 0†

1.627 ± 0.7281

1.458 ± 0.7736

1.537 ± 0.7548

 Week 52

0.792 ± 0.8241

0.840 ± 0.7972

0.817 ± 0.8075

PtAP

 Week 0†

71.67 ± 20.203

65.46 ± 21.722

68.37 ± 21.182

 Week 52

21.43 ± 19.788

25.62 ± 22.269

23.66 ± 21.173

PtGADA

 Week 0†

69.52 ± 21.619

66.58 ± 20.306

67.96 ± 20.912

 Week 52

28.09 ± 23.129

26.71 ± 22.575

27.36 ± 22.769

PhGADA

 Week 0†

76.09 ± 14.748

69.12 ± 17.170

72.39 ± 16.400

 Week 52

18.16 ± 13.625

16.49 ± 12.324

17.27 ± 12.933

  1. Data are presented as mean ± standard deviation, or number of patients (%)
  2. †Week 0 data are given for the population of the extension study only (maintenance group, n = 69/switch group, n = 78)
  3. CRP C-reactive protein, DAS28-ESR disease activity score in 28 joints based on erythrocyte sedimentation rate, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire Disability Index, MTX methotrexate, PhGADA physician’s global assessment of disease activity, PtAP patient’s assessment of arthritis pain, PtGADA patient’s global assessment of disease activity, RA rheumatoid arthritis