Table 1.
Baseline patient demographic and disease characteristics (full analysis set)
| Demographic variable | LBEC0101 (n=185) |
ETN-RP (n=187) |
Overall (n=372) |
| Age, years | 52.8±11.6 | 55.5±10.9 | 54.1±11.3 |
| Sex, female | 150 (81.1) | 166 (88.8) | 316 (84.9) |
| Weight, kg | 58.1±12.2 | 56.3±10.1 | 57.2±11.2 |
| Functional status in RA | |||
| I | 31 (16.8) | 34 (18.2) | 65 (17.5) |
| II | 121 (65.4) | 121 (64.7) | 242 (65.1) |
| III | 33 (17.8) | 32 (17.1) | 65 (17.5) |
| IV | 0 | 0 | 0 |
| Duration since first RA diagnosis, years | 7.6±7.6 | 7.8±7.6 | 7.7±7.6 |
| Rheumatoid factor test result, positive | 144 (77.8) | 144 (77.0) | 288 (77.4) |
| Tender joint count from 68 joints | 17.5±10.6. | 18.0±10.8 | 17.8±10.7 |
| Tender joint count from 28 joints | 11.0±6.0 | 11.7±5.9 | 11.3±5.9 |
| Swollen joint count from 66 joints | 13.4±7.5 | 13.7±7.5 | 13.6±7.5 |
| Swollen joint count from 28 joints | 9.2±4.6 | 9.8±5.1 | 9.5±4.8 |
| DAS28-ESR | 6.13±0.899 | 6.26±0.863 | 6.19±0.882 |
| ESR, mm/hour | 49.2±23.8 | 51.5±23.8 | 50.4±23.8 |
| CRP, mg/dL | 1.63±1.8 | 1.7±2.1 | 1.7±1.9 |
| MTX dose, mg/week | 11.3±2.9 | 11.1±3.0 | 11.2±3.0 |
| HAQ-DI | 1.3±0.7 | 1.2±0.7 | 1.2±0.7 |
| PtAP | 64.5±23.2 | 61.5±23.0 | 63.0±23.1 |
| PtGADA | 61.8±23.6 | 62.2±22.6 | 62.0±23.1 |
| PhGADA | 66.9±18.9 | 65.1±18.3 | 66.0±18.6 |
| Patients who used biologics previously and corticosteroids at baseline, n (%) | |||
| Previous use of biologics | 31 (16.8) | 29 (15.5) | 60 (16.1) |
| Baseline corticosteroids | 130 (70.3) | 119 (63.6) | 249 (66.9) |
Data are presented as mean±SD or n (%).
CRP, C reactive protein; DAS28-ESR, disease activity score in 28 joints based on erythrocyte sedimentation rate; ESR, erythrocyte sedimentation rate; ETN-RP, etanercept reference product; 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.