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