Table 1.
Demographics and baseline disease characteristics, including baseline scores for disease activity assessments (safety population)*
| CT-P10 N=102 |
RTX N=51 |
|
|---|---|---|
| Age (years) | 49.8±12.6 | 51.3±10.9 |
| Sex, no. (%) of patients | ||
| Female | 88 (86.3) | 46 (90.2) |
| Male | 14 (13.7) | 5 (9.8) |
| Ethnicity, no. (%) of patients | ||
| Caucasian | 69 (67.6) | 35 (68.6) |
| Asian | 15 (14.7) | 9 (17.6) |
| Other | 18 (17.6) | 7 (13.7) |
| Height (cm) | 161.9±8.1 | 162.1±8.7 |
| Weight (kg) | 71.4±17.7 | 72.4±16.0 |
| Body mass index (kg/m2) | 27.2±6.0 | 27.5±5.5 |
| Disease duration (years) | 11.0±7.8 | 10.3±9.1 |
| C reactive protein (mg/dL) | 1.8±1.7 | 2.1±3.0 |
| Erythrocyte sedimentation rate (mm/hour) | 49.5±24.5 | 50.1±26.7 |
| RF positive, no. (%) of patients | 82 (80.4) | 40 (78.4) |
| Anti-CCP positive, no. (%) of patients | 86 (84.3) | 43 (84.3) |
| Swollen joint count (66 joints assessed) | 16.5±8.2 | 14.5±7.0 |
| Tender joint count (68 joints assessed) | 27.4±14.8 | 27.1±14.2 |
| Disease Activity Score in 28 joints | ||
| C reactive protein | 6.0±0.9 | 6.0±0.9 |
| Erythrocyte sedimentation rate | 6.8±0.9 | 6.7±0.9 |
| Health Assessment Questionnaire Disability Index score | 1.7±0.7 | 1.7±0.7 |
| Prior anti-TNF agents, no. (%) of patients | ||
| 1 | 88 (86.3) | 42 (82.4) |
| 2 | 14 (13.7) | 9 (17.6) |
| Prior anti-TNF agent status, no. (%) of patients | ||
| Failure | 93 (91.2) | 47 (92.2) |
| Intolerance | 9 (8.8) | 4 (7.8) |
| Duration of prior TNF-antagonist use (months) | 18.9±20.3 | 23.7±26.7 |
| Prior TNF antagonists used, no. (%) of patients† | ||
| Adalimumab | 37 (36.3) | 18 (35.3) |
| Certolizumab | 3 (2.9) | 2 (3.9) |
| Etanercept | 30 (29.4) | 19 (37.3) |
| Golimumab | 12 (11.8) | 3 (5.9) |
| Infliximab | 32 (31.4) | 19 (37.3) |
| Investigational drug‡ | 3 (2.9) | 1 (2.0) |
| Weekly dose of MTX at baseline (mg) | 15.4±4.8 | 15.7±4.1 |
*Except where indicated otherwise, values are mean±SD.
†Some patients had previously received more than one anti-TNF agent.
‡Refers to any anti-TNF agent given in a prior study.
CCP, cyclic citrullinated peptide; MTX, methotrexate; RF, rheumatoid factor; RTX, rituximab; TNF, tumour necrosis factor.